Aortic Insufficiency, Aortic Stenosis, Aortic Valve Failure, Aortic Valve Stenosis
Conditions
Brief summary
The objective of this clinical trial is to collect data on procedural safety and device performance of the Portico and Navitor devices and FlexNav delivery system to treat patients with severe aortic stenosis in the Indian population.
Detailed description
The objective of this Phase IV clinical trial is to characterize the procedural safety and device performance of the Portico valve, the Navitor Valve, the FlexNav delivery system and FlexNav or Navitor loading system to treat patients with severe aortic stenosis.
Interventions
DEVICETranscatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement for the treatment of patients with severe aortic stenosis
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject must provide written informed consent prior to any clinical investigation-related procedure. 2. Are \>60 years of age in host country, have severe symptomatic (NYHA class ≥ II) aortic stenosis (AS), at high or extreme surgical risk and have been identified as a candidate for a Portico or Navitor valve implant. 3. Subjects must have a Society of Thoracic Surgeons (STS) score of ≥7% OR documented heart team agreement of high or extreme risk for surgical aortic valve replacement due to frailty or co-morbidities not captured by the STS score.
Exclusion criteria
1. Have tested positive for the Corona Virus Disease 2019 (COVID-19) virus at any time AND currently have residual signs or symptoms associated with the COVID-19 virus (eg. evidence of thrombosis, damaged/inflamed heart muscle, damaged/inflamed lung tissue, etc.) 2. Have sepsis, including active endocarditis 3. Have any evidence of left ventricular or atrial thrombus 4. Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable 5. Have a non-calcified aortic annulus 6. Have congenital bicuspid or unicuspid leaflet configuration 7. Are unable to tolerate antiplatelet/anticoagulant therapy 8. Are pregnant at the time of signing informed consent 9. Are currently participating in a drug or device study that may impact this study (unless prior sponsor approval for co-enrollment is granted)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VARC-2 Defined Event Rate of All Cause Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure | 30 days post index procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. |
| VARC-2 Defined Event Rate of Cardiovascular Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure | 30 days post index procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. |
| Myocardial Infarction Rate | 30 days post index procedure | Myocardial Infarction rate: percent of subjects who experienced a myocardial infarction within 30 days of the implant/index procedure |
| VARC-2 Defined Event Rate of Stroke (Including Disabling and Non-disabling, Percent of Subjects) at 30 Days From the Implant/Index Procedure | 30 days post index procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. |
| VARC-2 Defined Event Rate of Bleeding (Life-threatening, Major, Minor, Percent of Subjects) at 30 Days From the Implant/Index Procedure | 30 days post index procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. |
| VARC-2 Defined Event Rate of Acute Kidney Injury (Percent of Subjects) at 30 Days From the Implant/Index Procedure | 30 days post index procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. |
| VARC-2 Defined Event Rate of Vascular Access Site and Access-related Complications (Major and Minor, Percent of Subjects) at 30 Days From the Implant/Index Procedure | 30 days post index procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. |
| VARC-2 Defined Event Rate of Coronary Obstruction (Percent of Subjects) at 30 Days From the Implant/Index Procedure | 30 days post index procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. |
| VARC-2 Defined Event Rate of Permanent Pacemaker Insertion (Percent of Subjects) at 30 Days From the Implant/Index Procedure | 30 days post index procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. |
| Percentage of Subjects With Implant Success | During procedure | Defined as absence of procedural mortality, correct positioning of a single Portico prosthetic heart valve into the proper anatomical location, no conversion to open surgery |
| Echocardiographic Assessment of the Mean Aortic Gradient | 30 days post index procedure | Units=mmHg |
| Echocardiographic Assessment of Effective Orifice Area (EOA) | 30 days post index procedure | units = cm2 |
| Echocardiographic Assessment of Paravalvular Leak (PVL) Per VARC-2 Definitions at 30 Days. | 30 days post index procedure | Reported as either none/trace, mild, moderate, or severe |
| VARC-2 Defined Event Rate of All-Cause Mortality (Percent of Subjects) at 9 Months Post Implant/Index Procedure | 9 months post index procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. |
| VARC-2 Defined Event Rate of Stroke (Including Disabling and Non-disabling, Percent of Subjects) at 9 Months Post-implant/Index Procedure | 9 months post index procedure | The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. |
| New York Heart Association (NYHA) Functional Class | 30 days post index procedure | Reported as the percent of subjects by NYHA class from baseline to 30 days and from baseline to 9 months; NYHA Class was measured as class I, II, III, or IV. Symptoms are worsening from I to IV. |
| EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire | 30 Days | Patients are asked to rate their perception of their health on the day they complete the assessment on a scale of 0 to 100. A score of 100 means the patient has the best health they can imagine, and a score of 0 means the worst health they can imagine. The reported value is the average of all patient scores reported at the specified time point for the specified patient group. |
Countries
India
Contacts
STUDY_DIRECTORBarathi Sethuraman
Abbott
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 74.2 years |
| EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire | 72.5 Scores on a scale STANDARD_DEVIATION 9.2 |
| NYHA Functional Class Class I | 0 Participants |
| NYHA Functional Class Class II | 3 Participants |
| NYHA Functional Class Class III | 5 Participants |
| NYHA Functional Class Class IV | 0 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 20 | 0 / 10 |
| other Total, other adverse events | 10 / 20 | 7 / 10 |
| serious Total, serious adverse events | 7 / 20 | 1 / 10 |
Outcome results
None listed