Severe Aortic Stenosis, Symptomatic Degenerative Aortic Stenosis
Conditions
Keywords
Portico™ valve, Portico™ valve delivery system, Portico™ valve loading system, Transcatheter Aortic Valve Replacement, Aortic Stenosis, Heart Valve Prosthesis, TAVR, TAVR Registry, Transcatheter Aortic Valve Implant, TAVI, TAVI Registry, FlexNav delivery system, FlexNav loading system
Brief summary
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative aortic stenosis.
Detailed description
The CONFIDENCE registry study will be conducting as a prospective, non-randomized, observational, single-arm, multi-center study. Approximately 1000 subjects with severe symptomatic (NYHA class ≥ II) aortic stenosis (AS), will undergo Portico™ Transcatheter Aortic Heart Valve implantation. The subject data will be collected at baseline, index procedure, pre- discharge, 30 days and 12 months from the index procedure.
Interventions
DEVICEPortico™ Valve, Portico Delivery System(s) and Loading System(s)
Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
DEVICEPortico™ Valve, FlexNav Delivery System(s) and Loading System(s)
Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
Sponsors
Abbott Medical Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This registry will include market released Portico™ valves (23mm, 25mm, 27mm and 29mm), delivery systems and loading systems. The registry will also allow future iterations of the Portico valve and delivery system along with expanded indications to be included as they receive approval for commercial use in the country where the subject is enrolled.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects who are ≥18 years of age or legal age in host country and have been identified as a candidate for a Portico™ valve implant 2. Subjects who have been informed of the nature of the study, agree to its provisions and have provided written informed consent as approved by the Ethics Committee (EC) of the respective clinical center
Exclusion criteria
1. Have sepsis, including active endocarditis 2. Have any evidence of left ventricular or atrial thrombus 3. Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable 4. Have a non-calcified aortic annulus 5. Have congenital bicuspid or unicuspid leaflet configuration 6. Are unable to tolerate antiplatelet/anticoagulant therapy 7. Are pregnant at the time of signing informed consent 8. Are currently participating in a drug or device study that may impact the registry (unless prior sponsor approval for co-enrollment is granted)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Mortality | 30 days from the index procedure | Death due to proximate cardiac cause, non-coronary vascular conditions, procedure-related deaths, valve-related deaths, sudden or unwitnessed death and unknown cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Stroke | At 30 days | — |
| Number of Subjects With Bleeding Events | At 30 days | — |
| Number of Subjects With Acute Kidney Injury | At 30 days | The increase in creatinine must occur within 48 hours. Stage 1: Increase in serum creatinine to 150% to 199% (1.5 to 1.99 X increase compared with baseline) or increase of greater than or equal to 0.3 mg/dL (26.4 mmol/L) or Urine output \<0.5 mL/kg per hour for \>6 but \<12 hours. Stage 2: Increase in serum creatinine to 200% to 299% (2.0 to 2.99 X increase compared with baseline) or Urine output \<0.5 mL/kg per hour for \>12 but \<24 hours. Stage 3: Increase in serum creatinine to greater than or equal to 300% (3 X increase compared with baseline) or serum creatinine of ≥ 4.0 mg/dL (354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)or Urine output \<0.3 mL/kg per hour for ≥24 hours or anuria for ≥12 hours. Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria. |
| Number of Subjects With Vascular Complications | At 30 days | — |
| Number of Subjects With Annular Rupture | At 30 days | — |
| Number of Subjects With Coronary Obstruction | At 30 days | — |
| Number of Subjects Undergoing Conversion To Open Surgery | At 30 days | — |
| Number Of Subjects Undergoing Transcatheter Valve-In-Valve Deployment | At 30 days | — |
| Number Of Subjects With Valve Embolization | At 30 days | — |
| Number of Subjects With Myocardial Infarction | At 30 days | — |
| Vessel Diameter | At 30 days | — |
| Introducer Sheath Used | At 30 days | This is a yes or no question on the CRF. Sites report if the implanter used an introducer sheath (a special device used to facilitate introduction of the investigational device into the subjects vasculature). |
| Implant Success | At 30 days | — |
| Effective Orifice Area | At 30 days | Effective orifice area is a measure of the working area of the implanted valve determined by echocardiograph. |
| Aortic Valve Mean Gradient | At 30 days | Aortic valve mean gradient is a measure of the pressure gradient across the aortic valve measured by echocardiograph. |
| Number of Subjects With Paravalvular Leak (PVL) | At 30 days | — |
| NYHA Classification | At 30 days | NYHA Functional Classification is a system used to assess patient heart failure severity based on their limitations of physical activity. The four classes are described below: Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort. Subjects' NYHA Classification based on above criteria was assessed during follow up, and subjects were assigned to one of four classifications. Results are presented as percentage of all available subjects who were assigned each functional class (I-IV). |
| EQ5D-3L Visual Analog Scale Value | At 30 days | The EQ-5D-3L consists of EuroQoL 5 questions and 3 answering levels. The rating of questions includes: Level 1 no problems; Level 2 some problems; Level 3 Significant problems; Worst case is 15 points; and best case is 5 points using index. The Visual analogue scale VAS 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state. |
| Kaplan-Meier Rate of All-cause Mortality | At 12 months | Kaplan-Meier (KM) percentage of subjects who died. KM is a statistical method that attempts to account for other factors that may have reduced the number of subjects evaluable at a given time point. |
| Number Of Subjects Undergoing Naïve Permanent Pacemaker Insertion | At 30 days | — |
Countries
Australia, Belgium, Czechia, Germany, Italy, Poland, Spain, Switzerland, United Kingdom
Participant flow
Recruitment details
Between October 2018 and July 2021, implantation with a Portico™ transcatheter heart valve (THV) was attempted in 1001 subjects. This clinical investigation includes 27 sites in 8 countries across Europe and 1 site in Australia.
Participants by arm
| Arm | Count |
|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system. | 501 |
| Portico™ Valve, FlexNav Delivery and Loading System(s) Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems. | 500 |
| Total | 1,001 |
Baseline characteristics
| Characteristic | Portico™ Valve, FlexNav Delivery and Loading System(s) | Portico™ Valve, Delivery System(s) and Loading System(s) | Total |
|---|---|---|---|
| Age, Continuous | 82.3 years STANDARD_DEVIATION 5.3 | 81.7 years STANDARD_DEVIATION 5.4 | 82.0 years STANDARD_DEVIATION 5.3 |
| Baseline EQ5D-3L Visual Analog Scale Value | 60.1 units on a scale STANDARD_DEVIATION 17.8 | 60.8 units on a scale STANDARD_DEVIATION 18.5 | 60.4 units on a scale STANDARD_DEVIATION 18.1 |
| Hypertension | 431 Participants | 440 Participants | 871 Participants |
| NYHA Classification NYHA I | 4 Participants | 14 Participants | 18 Participants |
| NYHA Classification NYHA II | 185 Participants | 160 Participants | 345 Participants |
| NYHA Classification NYHA III | 293 Participants | 295 Participants | 588 Participants |
| NYHA Classification NYHA IV | 18 Participants | 32 Participants | 50 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Australia | 8 Participants | 20 Participants | 28 Participants |
| Region of Enrollment Belgium | 0 Participants | 4 Participants | 4 Participants |
| Region of Enrollment Czechia | 42 Participants | 25 Participants | 67 Participants |
| Region of Enrollment Germany | 195 Participants | 272 Participants | 467 Participants |
| Region of Enrollment Italy | 68 Participants | 43 Participants | 111 Participants |
| Region of Enrollment Poland | 24 Participants | 10 Participants | 34 Participants |
| Region of Enrollment Spain | 138 Participants | 71 Participants | 209 Participants |
| Region of Enrollment Switzerland | 0 Participants | 12 Participants | 12 Participants |
| Region of Enrollment United Kingdom | 25 Participants | 44 Participants | 69 Participants |
| Sex: Female, Male Female | 307 Participants | 319 Participants | 626 Participants |
| Sex: Female, Male Male | 193 Participants | 182 Participants | 375 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 16 / 501 | 10 / 500 |
| other Total, other adverse events | 72 / 501 | 80 / 500 |
| serious Total, serious adverse events | 348 / 501 | 358 / 500 |
Outcome results
Primary
Cardiovascular Mortality
Death due to proximate cardiac cause, non-coronary vascular conditions, procedure-related deaths, valve-related deaths, sudden or unwitnessed death and unknown cause.
Time frame: 30 days from the index procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Cardiovascular Mortality | 15 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Cardiovascular Mortality | 6 Participants |
Secondary
Aortic Valve Mean Gradient
Aortic valve mean gradient is a measure of the pressure gradient across the aortic valve measured by echocardiograph.
Time frame: At 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Aortic Valve Mean Gradient | 7.38 mmHg | Standard Deviation 4.44 |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Aortic Valve Mean Gradient | 6.80 mmHg | Standard Deviation 2.79 |
Secondary
Effective Orifice Area
Effective orifice area is a measure of the working area of the implanted valve determined by echocardiograph.
Time frame: At 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Effective Orifice Area | 1.85 cm^2 | Standard Deviation 0.48 |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Effective Orifice Area | 1.80 cm^2 | Standard Deviation 0.49 |
Secondary
EQ5D-3L Visual Analog Scale Value
The EQ-5D-3L consists of EuroQoL 5 questions and 3 answering levels. The rating of questions includes: Level 1 no problems; Level 2 some problems; Level 3 Significant problems; Worst case is 15 points; and best case is 5 points using index. The Visual analogue scale VAS 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state.
Time frame: At 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | EQ5D-3L Visual Analog Scale Value | 66.5 units on a scale | Standard Deviation 18.3 |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | EQ5D-3L Visual Analog Scale Value | 66.0 units on a scale | Standard Deviation 18 |
Secondary
Implant Success
Time frame: At 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Implant Success | 488 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Implant Success | 488 Participants |
Secondary
Introducer Sheath Used
This is a yes or no question on the CRF. Sites report if the implanter used an introducer sheath (a special device used to facilitate introduction of the investigational device into the subjects vasculature).
Time frame: At 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Introducer Sheath Used | 469 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Introducer Sheath Used | 120 Participants |
Secondary
Kaplan-Meier Rate of All-cause Mortality
Kaplan-Meier (KM) percentage of subjects who died. KM is a statistical method that attempts to account for other factors that may have reduced the number of subjects evaluable at a given time point.
Time frame: At 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Kaplan-Meier Rate of All-cause Mortality | 13.7 percentage of All-cause Mortality |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Kaplan-Meier Rate of All-cause Mortality | 11.0 percentage of All-cause Mortality |
Secondary
Number of Subjects Undergoing Conversion To Open Surgery
Time frame: At 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Number of Subjects Undergoing Conversion To Open Surgery | 3 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Number of Subjects Undergoing Conversion To Open Surgery | 3 Participants |
Secondary
Number Of Subjects Undergoing Naïve Permanent Pacemaker Insertion
Time frame: At 30 days
Population: Subjects with a pacemaker at baseline are not included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Number Of Subjects Undergoing Naïve Permanent Pacemaker Insertion | 87 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Number Of Subjects Undergoing Naïve Permanent Pacemaker Insertion | 84 Participants |
Secondary
Number Of Subjects Undergoing Transcatheter Valve-In-Valve Deployment
Time frame: At 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Number Of Subjects Undergoing Transcatheter Valve-In-Valve Deployment | 3 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Number Of Subjects Undergoing Transcatheter Valve-In-Valve Deployment | 6 Participants |
Secondary
Number of Subjects With Acute Kidney Injury
The increase in creatinine must occur within 48 hours. Stage 1: Increase in serum creatinine to 150% to 199% (1.5 to 1.99 X increase compared with baseline) or increase of greater than or equal to 0.3 mg/dL (26.4 mmol/L) or Urine output \<0.5 mL/kg per hour for \>6 but \<12 hours. Stage 2: Increase in serum creatinine to 200% to 299% (2.0 to 2.99 X increase compared with baseline) or Urine output \<0.5 mL/kg per hour for \>12 but \<24 hours. Stage 3: Increase in serum creatinine to greater than or equal to 300% (3 X increase compared with baseline) or serum creatinine of ≥ 4.0 mg/dL (354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)or Urine output \<0.3 mL/kg per hour for ≥24 hours or anuria for ≥12 hours. Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.
Time frame: At 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Number of Subjects With Acute Kidney Injury | Stage 1 | 4 Participants |
| Portico™ Valve, Delivery System(s) and Loading System(s) | Number of Subjects With Acute Kidney Injury | Stage 2 | 0 Participants |
| Portico™ Valve, Delivery System(s) and Loading System(s) | Number of Subjects With Acute Kidney Injury | Stage 3 | 7 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Number of Subjects With Acute Kidney Injury | Stage 1 | 5 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Number of Subjects With Acute Kidney Injury | Stage 2 | 3 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Number of Subjects With Acute Kidney Injury | Stage 3 | 4 Participants |
Secondary
Number of Subjects With Annular Rupture
Time frame: At 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Number of Subjects With Annular Rupture | 2 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Number of Subjects With Annular Rupture | 1 Participants |
Secondary
Number of Subjects With Bleeding Events
Time frame: At 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Number of Subjects With Bleeding Events | Life Threatening | 16 Participants |
| Portico™ Valve, Delivery System(s) and Loading System(s) | Number of Subjects With Bleeding Events | Major | 26 Participants |
| Portico™ Valve, Delivery System(s) and Loading System(s) | Number of Subjects With Bleeding Events | Minor | 31 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Number of Subjects With Bleeding Events | Life Threatening | 18 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Number of Subjects With Bleeding Events | Major | 33 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Number of Subjects With Bleeding Events | Minor | 20 Participants |
Secondary
Number of Subjects With Coronary Obstruction
Time frame: At 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Number of Subjects With Coronary Obstruction | 2 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Number of Subjects With Coronary Obstruction | 3 Participants |
Secondary
Number of Subjects With Myocardial Infarction
Time frame: At 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Number of Subjects With Myocardial Infarction | 2 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Number of Subjects With Myocardial Infarction | 1 Participants |
Secondary
Number of Subjects With Paravalvular Leak (PVL)
Time frame: At 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Number of Subjects With Paravalvular Leak (PVL) | None/Trace/Trivial | 185 Participants |
| Portico™ Valve, Delivery System(s) and Loading System(s) | Number of Subjects With Paravalvular Leak (PVL) | Mild | 188 Participants |
| Portico™ Valve, Delivery System(s) and Loading System(s) | Number of Subjects With Paravalvular Leak (PVL) | Moderate | 9 Participants |
| Portico™ Valve, Delivery System(s) and Loading System(s) | Number of Subjects With Paravalvular Leak (PVL) | Severe | 0 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Number of Subjects With Paravalvular Leak (PVL) | Severe | 0 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Number of Subjects With Paravalvular Leak (PVL) | None/Trace/Trivial | 158 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Number of Subjects With Paravalvular Leak (PVL) | Moderate | 7 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Number of Subjects With Paravalvular Leak (PVL) | Mild | 221 Participants |
Secondary
Number of Subjects With Stroke
Time frame: At 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Number of Subjects With Stroke | Disabling Stroke | 8 Participants |
| Portico™ Valve, Delivery System(s) and Loading System(s) | Number of Subjects With Stroke | Non-Disabling Stroke | 5 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Number of Subjects With Stroke | Disabling Stroke | 10 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Number of Subjects With Stroke | Non-Disabling Stroke | 6 Participants |
Secondary
Number Of Subjects With Valve Embolization
Time frame: At 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Number Of Subjects With Valve Embolization | 6 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Number Of Subjects With Valve Embolization | 7 Participants |
Secondary
Number of Subjects With Vascular Complications
Time frame: At 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Number of Subjects With Vascular Complications | Major | 32 Participants |
| Portico™ Valve, Delivery System(s) and Loading System(s) | Number of Subjects With Vascular Complications | Minor | 36 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Number of Subjects With Vascular Complications | Major | 41 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Number of Subjects With Vascular Complications | Minor | 25 Participants |
Secondary
NYHA Classification
NYHA Functional Classification is a system used to assess patient heart failure severity based on their limitations of physical activity. The four classes are described below: Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort. Subjects' NYHA Classification based on above criteria was assessed during follow up, and subjects were assigned to one of four classifications. Results are presented as percentage of all available subjects who were assigned each functional class (I-IV).
Time frame: At 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | NYHA Classification | NYHA I | 152 Participants |
| Portico™ Valve, Delivery System(s) and Loading System(s) | NYHA Classification | NYHA II | 218 Participants |
| Portico™ Valve, Delivery System(s) and Loading System(s) | NYHA Classification | NYHA III | 58 Participants |
| Portico™ Valve, Delivery System(s) and Loading System(s) | NYHA Classification | NYHA IV | 3 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | NYHA Classification | NYHA IV | 2 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | NYHA Classification | NYHA I | 159 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | NYHA Classification | NYHA III | 42 Participants |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | NYHA Classification | NYHA II | 254 Participants |
Secondary
Vessel Diameter
Time frame: At 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Portico™ Valve, Delivery System(s) and Loading System(s) | Vessel Diameter | 7.42 mm | Standard Deviation 1.44 |
| Portico™ Valve, FlexNav Delivery and Loading System(s) | Vessel Diameter | 7.09 mm | Standard Deviation 1.36 |