Aortic Valve Stenosis
Conditions
Keywords
Aortic Stenosis, CV-12-054-EU-PV, Heart Valve Prosthesis, Trans Catheter Aortic Valve Replacement, TAVR, Trans Catheter Aortic Valve Implant, TAVI
Brief summary
The purpose of this clinical investigation is to further assess the performance and safety profile of the commercially-available Portico™ TAVI System in patients with severe symptomatic aortic stenosis.
Detailed description
This is an international multicenter, prospective, non-randomized clinical investigation without concurrent or matched control, designed to assess the mid-term safety and performance of the Portico valve in patients with severe symptomatic aortic stenosis whom are high risk for surgical valve replacement. The primary endpoint is 1 year all-cause mortality. In addition, the performance and safety profile of the Portico valve will be further evaluated at 30 days, 1 year, and annually through 5 years post-implant. The investigation will be conducted at approximately 65 centers in approximately 15 countries in Europe, Middle-East, Africa, Canada, Australia and New Zealand.
Interventions
DEVICESt Jude Medical Portico replacement aortic valve
PROCEDURETranscatheter Aortic Valve Implant
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has signed the Patient Informed Consent prior to participating in the clinical investigation. * Patient has been referred for a Portico Valve implant as per Heart Team decision or patient has received a Portico Valve as per participation in an SJM sponsored regulatory or first-in-human trial. * Patient has senile degenerative aortic valve stenosis confirmed by echocardiographically derived criteria\*: * An initial aortic valve area (AVA) of less than or equal to (≤) 1.0 cm2 (or indexed EOA less than or equal to (≤) 0.6 cm2/m2) AND * A mean gradient greater than (\>)40 mmHg or jet velocity greater than (\>)4.0 m/s or Doppler Velocity Index less than (\<)0.25. If the mean gradient is \<40 mmHg and left ventricular ejection fraction (LVEF) \<55%, then the site may as well perform a dobutamine stress echo to see if the mean gradient increases to \>40 mmHg. (Baseline measurement taken by echo within 6 months of index procedure.) * Patient has a life expectancy more than (\>) 12 months. For patients enrolled in a French site: * Patient is at high risk for surgery as demonstrated by a Logistic EuroSCORE equal or more than (≥) 20 and/or a Society of Thoracic Surgeon (STS) mortality risk score of more than (\>) 10% and/or by clinical judgment of the Heart Team based on the individual risk profile (comorbidities). * Not applicable for a patient who has received a Portico Valve as per participation in an SJM sponsored Regulatory or First-In-Human trial.
Exclusion criteria
* Any case in which the Portico Valve would not be indicated for the patient as per current instructions for use (i.e any off-label use). * Patient has any other aortic valve than tricuspid one. * Patient has a prosthetic valve or ring in the aortic position. * Patient needs a concomitant structural heart procedure.. * Patient needs the usage of an embolic protection device. * Patient is unwilling or unable to comply with all clinical investigation-required follow-up evaluations. * Patient is pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With All-cause Mortality | 1 year post implant | Percentage of participants that died for any reason at 1 year post implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With All-cause Mortality (30 Days, Annually From 1 Year Through 5 Years) in Cohort B | 30 days through 5 years post implant | Number of participants who died for any reason at different time points such as 30 days, 1 year, 2 years, 3 years, 4 years and 5 years. |
| Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 30 days through 5 years post implant | Percentage of participants that died for cardiovascular or unknown reasons as defined by VARC-2 at 30 days through 5 years post implantation |
| Number of Participants With Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B | 30 days through 5 years post implant | Number of participants who died for any reason at different time points such as 30 days, 1 year, 2 years, 3 years, 4 years and 5 years. |
| Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 30 days through 5 years post implant | Percentage of participants that died for any reason at 30 days through 5 years post implantation |
| Number of Participants With Non-Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B | 30 days through 5 years post implant | Number of participants who died for any reason at different time points such as 30 days, 1 year, 2 years, 3 years, 4 years and 5 years. |
| Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 30 days through 5 years post implant | Percentage of participants with a myocardial infarction as defined by VARC-2 at 30 days through 5 years post implantation post implantation |
| Number of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | 30 days through 5 years post implant | Number of participants with a myocardial infarction as defined by VARC-2 at 30 days through 5 years post implantation post implantation |
| Percentage of Participants With Vascular Access Site Complication as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 30 days post implant | Percentage of participants with vascular access site complication (major or minor) as defined by VARC-2 at 30 days post implantation |
| Percentage of Participants With Bleeding Events as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 30 days post implant | Percentage of participants with a bleeding events (life threatening, major or minor) as defined by VARC-2 at 30 days post implantation |
| Percentage of Participants With Stage 1, 2 and 3 Acute Kidney Injury as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 30 days post implant | Percentage of participants with a Stage 1, 2 or Stage 3 acute kidney injury as defined by VARC-2 at 30 days post implantation |
| Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area) | 30 days through 5 years post implant | The aortic valve area as interpreted by an independent echocardiographic core laboratory at 30 days through 5 years post implantation |
| Percentage of Participants With All Cause Mortality in Cohort A | 30 days through 5 years post implant | Percentage of participants that died for any reason at 30 days through 5 years post implantation |
| Mean Quality of Life Assessment in Cohort A | 30 days and 1 year post implant | EuroQuol-5 Dimensions (EQ5D) is a standardized instrument for use as a measure of health outcome applicable to a wide range of health conditions and treatments. A visual analog scale (VAS) for health is also included in the measure as a patient-reported estimate of overall health status. This scale ranges between 0-100, where 0 is 'the worst health you can imagine' and 100 is 'the best health you can imagine'. |
| Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | 30 days post implant | The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations. |
| Mean Six Minute Walk Test (6MWT) | 30 days through 5 years post implant | Distance in metres that the participant can walk in 6 minutes. The six-minute walking test (6MWT) is a commonly used objective measure of functional exercise capacity in individuals with moderately severe impairment. |
| Percentage of Participants With Transient Ischemic Attack in Cohort A | 30 days through 5 years post implantation | Percentage of participants with transient ischemic attack as defined by VARC-2 at 30 days through 5 years post implantation |
| Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 30 days post implant | Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 30 days post implantation |
| Number of Participants With Transient Ischemic Attack in Cohort B | 30 days through 5 years post implantation | Number of participants with transient ischemic attack as defined by VARC-2 at 30 days through 5 years post implantation |
| Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | 2 years post implant | Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 2 years post implantation |
| Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 30 days post implant | Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 30 days post implantation |
| Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | 2 years post implant | Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 2 years post implantation |
| Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A | 30 days post implant | Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 30 days post implantation |
| Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | 2 years post implant | Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 2 years post implantation |
| Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient) | 30 days through 5 years post implant | The mean transvalvular gradient as interpreted by an independent echocardiographic core laboratory at 30 days through 5 years post implantation |
Countries
Australia, Belgium, Canada, Denmark, France, Germany, Israel, Italy, Lithuania, Netherlands, Spain, Switzerland, United Kingdom
Participant flow
Recruitment details
Of the 973 subjects who were screened in Cohort A, 941 underwent an implant attempt with a Portico THV. Subjects in Cohort B were implanted in previous St. Jude Medical sponsored regulatory (pre-market) investigations and first-in-human trials, and consented for participation after completion of 1 year follow-up in their initial study.
Pre-assignment details
The first subject was enrolled on April 16, 2013 and the last subject was enrolled on June 28, 2017. Among the 973 subjects who were screened initially in Cohort A, 32 were excluded due to screen failures or exit without a Portico implant attempt. Hence only 941 subjects from Cohort A and 59 from Cohort B were considered for baseline, endpoint and safety analyses.
Participants by arm
| Arm | Count |
|---|---|
| Cohort A Patients implanted with a Portico valve after CE mark | 941 |
| Cohort B Patients implanted in previous SJM-sponsored premarket studies | 59 |
| Total | 1,000 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 382 | 18 |
| Overall Study | Lost to Follow-up | 31 | 2 |
| Overall Study | Other Reasons | 19 | 0 |
| Overall Study | Patient Non-Compliance | 1 | 0 |
| Overall Study | Physician Decision | 3 | 0 |
| Overall Study | Study Stopped/Terminated at Site | 5 | 0 |
| Overall Study | Withdrawal by Subject | 102 | 5 |
Baseline characteristics
| Characteristic | Cohort A | Cohort B | Total |
|---|---|---|---|
| Age, Continuous | 82.4 years STANDARD_DEVIATION 5.9 | 82.3 years STANDARD_DEVIATION 4.6 | 82.4 years STANDARD_DEVIATION 5.9 |
| NYHA Classification NYHA I | 29 Participants | 0 Participants | 29 Participants |
| NYHA Classification NYHA II | 309 Participants | 16 Participants | 325 Participants |
| NYHA Classification NYHA III | 554 Participants | 41 Participants | 595 Participants |
| NYHA Classification NYHA IV | 45 Participants | 2 Participants | 47 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Australia | 129 participants | 7 participants | 136 participants |
| Region of Enrollment Belgium | 34 participants | 0 participants | 34 participants |
| Region of Enrollment Canada | 60 participants | 0 participants | 60 participants |
| Region of Enrollment Denmark | 56 participants | 1 participants | 57 participants |
| Region of Enrollment France | 20 participants | 0 participants | 20 participants |
| Region of Enrollment Germany | 410 participants | 39 participants | 449 participants |
| Region of Enrollment Israel | 2 participants | 0 participants | 2 participants |
| Region of Enrollment Italy | 133 participants | 0 participants | 133 participants |
| Region of Enrollment Lithuania | 7 participants | 0 participants | 7 participants |
| Region of Enrollment Netherlands | 29 participants | 12 participants | 41 participants |
| Region of Enrollment Spain | 35 participants | 0 participants | 35 participants |
| Region of Enrollment Switzerland | 4 participants | 0 participants | 4 participants |
| Region of Enrollment United Kingdom | 22 participants | 0 participants | 22 participants |
| Sex: Female, Male Female | 618 Participants | 37 Participants | 655 Participants |
| Sex: Female, Male Male | 323 Participants | 22 Participants | 345 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 382 / 941 | 18 / 59 |
| other Total, other adverse events | 526 / 941 | 22 / 59 |
| serious Total, serious adverse events | 754 / 941 | 40 / 59 |
Outcome results
Primary
Percentage of Participants With All-cause Mortality
Percentage of participants that died for any reason at 1 year post implantation
Time frame: 1 year post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A | Percentage of Participants With All-cause Mortality | 12.1 percentage of participants |
Secondary
Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area)
The aortic valve area as interpreted by an independent echocardiographic core laboratory at 30 days through 5 years post implantation
Time frame: 30 days through 5 years post implant
Population: The data for the number of participants available at the time has been provided. For Cohort A, a total of 941 subjects participated in the study; however, only 574 were available for AVA analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area) | 1 year | 1.74 cm^2 | Standard Deviation 0.48 |
| Cohort A | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area) | 3 years | 1.76 cm^2 | Standard Deviation 0.53 |
| Cohort A | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area) | 30 days | 1.78 cm^2 | Standard Deviation 0.48 |
| Cohort A | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area) | 4 years | 1.76 cm^2 | Standard Deviation 0.57 |
| Cohort A | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area) | 5 years | 1.84 cm^2 | Standard Deviation 0.47 |
| Cohort A | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area) | 2 years | 1.84 cm^2 | Standard Deviation 0.57 |
| Cohort B | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area) | 5 years | 1.74 cm^2 | Standard Deviation 0.48 |
| Cohort B | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area) | 30 days | NA cm^2 | — |
| Cohort B | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area) | 1 year | NA cm^2 | — |
| Cohort B | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area) | 2 years | 1.88 cm^2 | Standard Deviation 0.49 |
| Cohort B | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area) | 3 years | 1.76 cm^2 | Standard Deviation 0.45 |
| Cohort B | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area) | 4 years | 1.88 cm^2 | Standard Deviation 0.48 |
Secondary
Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient)
The mean transvalvular gradient as interpreted by an independent echocardiographic core laboratory at 30 days through 5 years post implantation
Time frame: 30 days through 5 years post implant
Population: The data for the number of participants available at the time has been provided. For Cohort A, a total of 941 subjects participated in the study; however, only 684 were available for mean aortic gradient analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient) | 30 days | 8.58 mmHg | Standard Deviation 3.89 |
| Cohort A | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient) | 1 year | 8.67 mmHg | Standard Deviation 4.11 |
| Cohort A | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient) | 2 years | 7.81 mmHg | Standard Deviation 3.78 |
| Cohort A | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient) | 3 years | 7.61 mmHg | Standard Deviation 4.29 |
| Cohort A | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient) | 4 years | 7.99 mmHg | Standard Deviation 4.1 |
| Cohort A | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient) | 5 years | 6.69 mmHg | Standard Deviation 3.52 |
| Cohort B | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient) | 4 years | 7.69 mmHg | Standard Deviation 4.07 |
| Cohort B | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient) | 30 days | NA mmHg | — |
| Cohort B | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient) | 3 years | 7.34 mmHg | Standard Deviation 4.03 |
| Cohort B | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient) | 1 year | NA mmHg | — |
| Cohort B | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient) | 5 years | 6.44 mmHg | Standard Deviation 4 |
| Cohort B | Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient) | 2 years | 8.04 mmHg | Standard Deviation 3 |
Secondary
Mean Quality of Life Assessment in Cohort A
EuroQuol-5 Dimensions (EQ5D) is a standardized instrument for use as a measure of health outcome applicable to a wide range of health conditions and treatments. A visual analog scale (VAS) for health is also included in the measure as a patient-reported estimate of overall health status. This scale ranges between 0-100, where 0 is 'the worst health you can imagine' and 100 is 'the best health you can imagine'.
Time frame: 30 days and 1 year post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up. For Cohort A, a total of 941 subjects participated in the study; however, only 774 were available for EQ5D analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A | Mean Quality of Life Assessment in Cohort A | 30 days | 67.3 score on a scale | Standard Deviation 18 |
| Cohort A | Mean Quality of Life Assessment in Cohort A | 1 year | 68.8 score on a scale | Standard Deviation 17.7 |
Secondary
Mean Six Minute Walk Test (6MWT)
Distance in metres that the participant can walk in 6 minutes. The six-minute walking test (6MWT) is a commonly used objective measure of functional exercise capacity in individuals with moderately severe impairment.
Time frame: 30 days through 5 years post implant
Population: The data for the number of participants available at the time has been provided. For Cohort A, a total of 941 subjects participated in the study; however, only 569 were available for 6 minute walk test.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A | Mean Six Minute Walk Test (6MWT) | 30 days | 276.3 meter | Standard Deviation 117.5 |
| Cohort A | Mean Six Minute Walk Test (6MWT) | 1 year | 285.75 meter | Standard Deviation 112.12 |
| Cohort A | Mean Six Minute Walk Test (6MWT) | 2 years | 276.4 meter | Standard Deviation 116.2 |
| Cohort A | Mean Six Minute Walk Test (6MWT) | 3 years | 283.4 meter | Standard Deviation 119.4 |
| Cohort A | Mean Six Minute Walk Test (6MWT) | 4 years | 288.4 meter | Standard Deviation 106.2 |
| Cohort A | Mean Six Minute Walk Test (6MWT) | 5 years | 286.4 meter | Standard Deviation 110.9 |
| Cohort B | Mean Six Minute Walk Test (6MWT) | 4 years | 236.4 meter | Standard Deviation 100 |
| Cohort B | Mean Six Minute Walk Test (6MWT) | 30 days | 250.60 meter | Standard Deviation 104.61 |
| Cohort B | Mean Six Minute Walk Test (6MWT) | 3 years | 244.4 meter | Standard Deviation 111.6 |
| Cohort B | Mean Six Minute Walk Test (6MWT) | 1 year | 257.18 meter | Standard Deviation 97.96 |
| Cohort B | Mean Six Minute Walk Test (6MWT) | 5 years | 197.5 meter | Standard Deviation 107.7 |
| Cohort B | Mean Six Minute Walk Test (6MWT) | 2 years | 253.4 meter | Standard Deviation 119.8 |
Secondary
Number of Participants With All-cause Mortality (30 Days, Annually From 1 Year Through 5 Years) in Cohort B
Number of participants who died for any reason at different time points such as 30 days, 1 year, 2 years, 3 years, 4 years and 5 years.
Time frame: 30 days through 5 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Number of Participants With All-cause Mortality (30 Days, Annually From 1 Year Through 5 Years) in Cohort B | 2 years | 4 Participants |
| Cohort A | Number of Participants With All-cause Mortality (30 Days, Annually From 1 Year Through 5 Years) in Cohort B | 3 years | 4 Participants |
| Cohort A | Number of Participants With All-cause Mortality (30 Days, Annually From 1 Year Through 5 Years) in Cohort B | 4 years | 5 Participants |
| Cohort A | Number of Participants With All-cause Mortality (30 Days, Annually From 1 Year Through 5 Years) in Cohort B | 5 years | 5 Participants |
Secondary
Number of Participants With Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B
Number of participants who died for any reason at different time points such as 30 days, 1 year, 2 years, 3 years, 4 years and 5 years.
Time frame: 30 days through 5 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Number of Participants With Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B | 2 years | 0 Participants |
| Cohort A | Number of Participants With Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B | 3 years | 4 Participants |
| Cohort A | Number of Participants With Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B | 4 years | 2 Participants |
| Cohort A | Number of Participants With Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B | 5 years | 4 Participants |
Secondary
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 2 years post implantation
Time frame: 2 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | New-onset atrial fibrillation | 1 Participants |
| Cohort A | Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | New pacemaker implant in pacemaker naïve patients | 1 Participants |
| Cohort A | Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | Overall PM implantation | 1 Participants |
Secondary
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 3 years post implantation
Time frame: 3 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | New-onset atrial fibrillation | 0 Participants |
| Cohort A | Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | New pacemaker implant in pacemaker naïve patients | 0 Participants |
| Cohort A | Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | Overall PM implantation | 0 Participants |
Secondary
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 5 years post implantation
Time frame: 5 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | New-onset atrial fibrillation | 1 Participants |
| Cohort A | Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | New pacemaker implant in pacemaker naïve patients | 0 Participants |
| Cohort A | Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | Overall PM implantation | 0 Participants |
Secondary
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 4 years post implantation
Time frame: 4 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | New-onset atrial fibrillation | 2 Participants |
| Cohort A | Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | New pacemaker implant in pacemaker naïve patients | 0 Participants |
| Cohort A | Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | Overall PM implantation | 0 Participants |
Secondary
Number of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Number of participants with a myocardial infarction as defined by VARC-2 at 30 days through 5 years post implantation post implantation
Time frame: 30 days through 5 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Number of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | 2 years | 0 Participants |
| Cohort A | Number of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | 3 years | 1 Participants |
| Cohort A | Number of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | 4 years | 1 Participants |
| Cohort A | Number of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | 5 years | 0 Participants |
Secondary
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
Time frame: 4 years post implant
Population: The data for the number of participants available at the time has been provided
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class I | 147 Participants |
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class II | 211 Participants |
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class III | 59 Participants |
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class IV | 6 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class IV | 1 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class I | 7 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class III | 5 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class II | 26 Participants |
Secondary
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
Time frame: 5 years post implant
Population: The data for the number of participants available at the time has been provided
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class I | 113 Participants |
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class II | 174 Participants |
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class III | 54 Participants |
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class IV | 4 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class IV | 1 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class I | 11 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class III | 8 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class II | 14 Participants |
Secondary
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
Time frame: 30 days post implant
Population: The data for the number of participants available at the time has been provided
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class I | 298 Participants |
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class II | 405 Participants |
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class III | 98 Participants |
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class IV | 7 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class IV | 0 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class I | 13 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class III | 6 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class II | 35 Participants |
Secondary
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
Time frame: 1 year post implant
Population: The data for the number of participants available at the time has been provided
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class I | 289 Participants |
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class II | 356 Participants |
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class III | 51 Participants |
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class IV | 3 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class IV | 1 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class I | 23 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class III | 10 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class II | 25 Participants |
Secondary
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
Time frame: 2 years post implant
Population: The data for the number of participants available at the time has been provided
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class I | 244 Participants |
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class II | 283 Participants |
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class III | 64 Participants |
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class IV | 4 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class IV | 0 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class I | 14 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class III | 10 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class II | 22 Participants |
Secondary
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
Time frame: 3 years post implant
Population: The data for the number of participants available at the time has been provided
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class I | 194 Participants |
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class II | 251 Participants |
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class III | 62 Participants |
| Cohort A | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class IV | 2 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class IV | 1 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class I | 15 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class III | 9 Participants |
| Cohort B | Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | Class II | 19 Participants |
Secondary
Number of Participants With Non-Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B
Number of participants who died for any reason at different time points such as 30 days, 1 year, 2 years, 3 years, 4 years and 5 years.
Time frame: 30 days through 5 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Number of Participants With Non-Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B | 2 years | 1 Participants |
| Cohort A | Number of Participants With Non-Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B | 3 years | 3 Participants |
| Cohort A | Number of Participants With Non-Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B | 4 years | 2 Participants |
| Cohort A | Number of Participants With Non-Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B | 5 years | 1 Participants |
Secondary
Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 3 years post implantation
Time frame: 3 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2year follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | Disabling | 0 Participants |
| Cohort A | Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | Non-disabling | 0 Participants |
Secondary
Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 2 years post implantation
Time frame: 2 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2year follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | Disabling | 0 Participants |
| Cohort A | Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | Non-disabling | 0 Participants |
Secondary
Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 4 years post implantation
Time frame: 4 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2year follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | Disabling | 0 Participants |
| Cohort A | Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | Non-disabling | 0 Participants |
Secondary
Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 5 years post implantation
Time frame: 5 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2year follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | Disabling | 0 Participants |
| Cohort A | Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B | Non-disabling | 0 Participants |
Secondary
Number of Participants With Transient Ischemic Attack in Cohort B
Number of participants with transient ischemic attack as defined by VARC-2 at 30 days through 5 years post implantation
Time frame: 30 days through 5 years post implantation
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Number of Participants With Transient Ischemic Attack in Cohort B | 2 years | 1 Participants |
| Cohort A | Number of Participants With Transient Ischemic Attack in Cohort B | 3 years | 0 Participants |
| Cohort A | Number of Participants With Transient Ischemic Attack in Cohort B | 4 years | 0 Participants |
| Cohort A | Number of Participants With Transient Ischemic Attack in Cohort B | 5 years | 0 Participants |
Secondary
Percentage of Participants With All Cause Mortality in Cohort A
Percentage of participants that died for any reason at 30 days through 5 years post implantation
Time frame: 30 days through 5 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With All Cause Mortality in Cohort A | 30 days | 2.7 percentage of participants |
| Cohort A | Percentage of Participants With All Cause Mortality in Cohort A | 1 year | 12.0 percentage of participants |
| Cohort A | Percentage of Participants With All Cause Mortality in Cohort A | 2 years | 19.5 percentage of participants |
| Cohort A | Percentage of Participants With All Cause Mortality in Cohort A | 3 years | 27.0 percentage of participants |
| Cohort A | Percentage of Participants With All Cause Mortality in Cohort A | 4 years | 35.7 percentage of participants |
| Cohort A | Percentage of Participants With All Cause Mortality in Cohort A | 5 years | 44.3 percentage of participants |
Secondary
Percentage of Participants With Bleeding Events as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a bleeding events (life threatening, major or minor) as defined by VARC-2 at 30 days post implantation
Time frame: 30 days post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Bleeding Events as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Life threatening | 3.3 percentage of participants |
| Cohort A | Percentage of Participants With Bleeding Events as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Major | 8.3 percentage of participants |
| Cohort A | Percentage of Participants With Bleeding Events as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Minor | 8.9 percentage of participants |
Secondary
Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants that died for cardiovascular or unknown reasons as defined by VARC-2 at 30 days through 5 years post implantation
Time frame: 30 days through 5 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 30 days | 2.5 percentage of participants |
| Cohort A | Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 1 year | 6.6 percentage of participants |
| Cohort A | Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 2 year | 9.8 percentage of participants |
| Cohort A | Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 3 year | 13.1 percentage of participants |
| Cohort A | Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 4 year | 18.5 percentage of participants |
| Cohort A | Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 5 year | 24.1 percentage of participants |
Secondary
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 2 years post implantation
Time frame: 2 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | New-onset atrial fibrillation | 5.9 percentage of participants |
| Cohort A | Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | New pacemaker implant in pacemaker naïve patients | 22.4 percentage of participants |
| Cohort A | Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Overall PM implantation | 20.4 percentage of participants |
Secondary
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 30 days post implantation
Time frame: 30 days post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | New-onset atrial fibrillation | 4.0 percentage of participants |
| Cohort A | Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | New pacemaker implant in pacemaker naïve patients | 19.0 percentage of participants |
| Cohort A | Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Overall PM implantation | 17.3 percentage of participants |
Secondary
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 1 year post implantation
Time frame: 1 year post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | New-onset atrial fibrillation | 5.3 percentage of participants |
| Cohort A | Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | New pacemaker implant in pacemaker naïve patients | 21.2 percentage of participants |
| Cohort A | Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Overall PM implantation | 19.4 percentage of participants |
Secondary
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 3 years post implantation
Time frame: 3 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | New-onset atrial fibrillation | 7.3 percentage of participants |
| Cohort A | Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | New pacemaker implant in pacemaker naïve patients | 23.6 percentage of participants |
| Cohort A | Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Overall PM implantation | 21.6 percentage of participants |
Secondary
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 4 years post implantation
Time frame: 4 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | New-onset atrial fibrillation | 8.8 percentage of participants |
| Cohort A | Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | New pacemaker implant in pacemaker naïve patients | 25.4 percentage of participants |
| Cohort A | Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Overall PM implantation | 23.2 percentage of participants |
Secondary
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 5 years post implantation
Time frame: 5 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | New-onset atrial fibrillation | 9.5 percentage of participants |
| Cohort A | Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | New pacemaker implant in pacemaker naïve patients | 27.7 percentage of participants |
| Cohort A | Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Overall PM implantation | 25.3 percentage of participants |
Secondary
Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a myocardial infarction as defined by VARC-2 at 30 days through 5 years post implantation post implantation
Time frame: 30 days through 5 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 30 days | 1.6 percentage of participants |
| Cohort A | Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 1 year | 2.5 percentage of participants |
| Cohort A | Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 2 years | 3.2 percentage of participants |
| Cohort A | Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 3 years | 3.6 percentage of participants |
| Cohort A | Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 4 years | 4.9 percentage of participants |
| Cohort A | Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 5 years | 6.5 percentage of participants |
Secondary
Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants that died for any reason at 30 days through 5 years post implantation
Time frame: 30 days through 5 years post implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 30 days | 0.2 percentage of participants |
| Cohort A | Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 1 year | 5.8 percentage of participants |
| Cohort A | Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 2 years | 10.8 percentage of participants |
| Cohort A | Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 3 years | 16.0 percentage of participants |
| Cohort A | Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 4 years | 21.1 percentage of participants |
| Cohort A | Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A | 5 years | 26.6 percentage of participants |
Secondary
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 5 years post implantation
Time frame: 5 years post implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | None/trace/trivial | 69.8 percentage of participants |
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Mild | 28.6 percentage of participants |
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Moderate | 1.6 percentage of participants |
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Severe | 0.0 percentage of participants |
| Cohort B | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Severe | 0.0 percentage of participants |
| Cohort B | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | None/trace/trivial | 69.6 percentage of participants |
| Cohort B | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Moderate | 0.0 percentage of participants |
| Cohort B | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Mild | 30.4 percentage of participants |
Secondary
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 2 years post implantation
Time frame: 2 years post implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | None/trace/trivial | 56.1 percentage of participants |
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Mild | 42.4 percentage of participants |
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Moderate | 1.5 percentage of participants |
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Severe | 0.0 percentage of participants |
| Cohort B | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Severe | 0.0 percentage of participants |
| Cohort B | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | None/trace/trivial | 57.5 percentage of participants |
| Cohort B | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Moderate | 0.0 percentage of participants |
| Cohort B | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Mild | 42.5 percentage of participants |
Secondary
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 3 years post implantation
Time frame: 3 years post implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | None/trace/trivial | 64.9 percentage of participants |
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Mild | 34.7 percentage of participants |
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Moderate | 0.4 percentage of participants |
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Severe | 0.0 percentage of participants |
| Cohort B | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Severe | 0.0 percentage of participants |
| Cohort B | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | None/trace/trivial | 70.6 percentage of participants |
| Cohort B | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Moderate | 0.0 percentage of participants |
| Cohort B | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Mild | 29.4 percentage of participants |
Secondary
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 4 years post implantation
Time frame: 4 years post implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | None/trace/trivial | 53.2 percentage of participants |
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Mild | 45.7 percentage of participants |
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Moderate | 1.1 percentage of participants |
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Severe | 0.0 percentage of participants |
| Cohort B | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Severe | 0.0 percentage of participants |
| Cohort B | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | None/trace/trivial | 50.0 percentage of participants |
| Cohort B | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Moderate | 0.0 percentage of participants |
| Cohort B | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Mild | 50.0 percentage of participants |
Secondary
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A
Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 1 year post implantation
Time frame: 1 year post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A | None/trace/trivial | 29.7 percentage of participants |
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A | Mild | 67.7 percentage of participants |
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A | Moderate | 2.6 percentage of participants |
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A | Severe | 0.0 percentage of participants |
Secondary
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A
Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 30 days post implantation
Time frame: 30 days post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A | None/trace/trivial | 28.4 percentage of participants |
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A | Mild | 67.6 percentage of participants |
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A | Moderate | 3.9 percentage of participants |
| Cohort A | Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A | Severe | 0.0 percentage of participants |
Secondary
Percentage of Participants With Stage 1, 2 and 3 Acute Kidney Injury as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a Stage 1, 2 or Stage 3 acute kidney injury as defined by VARC-2 at 30 days post implantation
Time frame: 30 days post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Stage 1, 2 and 3 Acute Kidney Injury as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Stage 1 | 0.4 percentage of participants |
| Cohort A | Percentage of Participants With Stage 1, 2 and 3 Acute Kidney Injury as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Stage 2 | 1.0 percentage of participants |
| Cohort A | Percentage of Participants With Stage 1, 2 and 3 Acute Kidney Injury as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Stage 3 | 2.0 percentage of participants |
Secondary
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 1 year post implantation
Time frame: 1 year post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Disabling | 2.1 percentage of participants |
| Cohort A | Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Non-disabling | 2.0 percentage of participants |
Secondary
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 4 years post implantation
Time frame: 4 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Disabling | 6.3 percentage of participants |
| Cohort A | Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Non-disabling | 4.3 percentage of participants |
Secondary
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 5 years post implantation
Time frame: 5 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Disabling | 7.8 percentage of participants |
| Cohort A | Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Non-disabling | 4.7 percentage of participants |
Secondary
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 30 days post implantation
Time frame: 30 days post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Disabling | 1.4 percentage of participants |
| Cohort A | Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Non-disabling | 1.2 percentage of participants |
Secondary
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 3 years post implantation
Time frame: 3 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Disabling | 4.3 percentage of participants |
| Cohort A | Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Non-disabling | 3.9 percentage of participants |
Secondary
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 2 years post implantation
Time frame: 2 years post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Disabling | 3.2 percentage of participants |
| Cohort A | Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Non-disabling | 3.2 percentage of participants |
Secondary
Percentage of Participants With Transient Ischemic Attack in Cohort A
Percentage of participants with transient ischemic attack as defined by VARC-2 at 30 days through 5 years post implantation
Time frame: 30 days through 5 years post implantation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Transient Ischemic Attack in Cohort A | 1 year | 1.4 percentage of participants |
| Cohort A | Percentage of Participants With Transient Ischemic Attack in Cohort A | 30 days | 0.4 percentage of participants |
| Cohort A | Percentage of Participants With Transient Ischemic Attack in Cohort A | 2 years | 1.9 percentage of participants |
| Cohort A | Percentage of Participants With Transient Ischemic Attack in Cohort A | 3 years | 1.9 percentage of participants |
| Cohort A | Percentage of Participants With Transient Ischemic Attack in Cohort A | 4 years | 2.5 percentage of participants |
| Cohort A | Percentage of Participants With Transient Ischemic Attack in Cohort A | 5 years | 2.8 percentage of participants |
Secondary
Percentage of Participants With Vascular Access Site Complication as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with vascular access site complication (major or minor) as defined by VARC-2 at 30 days post implantation
Time frame: 30 days post implant
Population: Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Percentage of Participants With Vascular Access Site Complication as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Major | 7.0 percentage of participants |
| Cohort A | Percentage of Participants With Vascular Access Site Complication as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A | Minor | 6.2 percentage of participants |