Aortic Valve Stenosis
Conditions
Keywords
Transcatheter, Transcatheter Valve Replacement, SAPIEN 3 Ultra
Brief summary
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.
Interventions
DEVICESAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV
Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System.
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
SAPIEN 3 Ultra System
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Severe, calcific aortic stenosis meeting the following transthoracic echocardiogram criteria: * Aortic valve area ≤ 1.0 cm2 OR aortic valve area index ≤ 0.6 cm2/m2 * Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg 2. New York Heart Association functional class ≥ II 3. Judged by the Heart Team to be at intermediate risk for open surgical therapy 4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion criteria
1. Native aortic annulus size unsuitable for available THV sizes on 3D imaging analysis 2. Aortic valve is unicuspid, bicuspid or non-calcified 3. Pre-existing mechanical or bioprosthetic valve in any position. 4. Severe aortic regurgitation (\> 3+) 5. Severe mitral regurgitation (\> 3+) or ≥ moderate stenosis 6. Ventricular dysfunction with left ventricular ejection fraction \< 30% 7. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation 8. Evidence of an acute myocardial infarction ≤ 30 days before the valve implant procedure 9. Subjects with planned concomitant ablation for atrial fibrillation 10. Hypertrophic cardiomyopathy with obstruction 11. Coronary anatomy that increases the risk of coronary artery obstruction post-TAVR 12. Complex coronary artery disease: 1. Unprotected left main coronary artery 2. SYNTAX score \> 32 3. Heart Team assessment that optimal revascularization cannot be performed 13. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath 14. Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system 15. Active bacterial endocarditis within 180 days of the valve implant procedure 16. Stroke or transient ischemic attack within 90 days of the valve implant procedure 17. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of the valve implant procedure 18. Severe lung disease (Forced Ejection Volume 1 \< 50% predicted) or currently on home oxygen 19. Severe pulmonary hypertension 20. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the valve implant procedure 21. History of cirrhosis or any active liver disease 22. Renal insufficiency and/or renal replacement therapy at the time of screening 23. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states 24. Inability to tolerate or condition precluding treatment with antithrombotic therapy during or after the valve implant procedure 25. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication 26. Significant frailty as determined by the Heart Team 27. Subject refuses blood products 28. Body mass index \> 50 kg/m2 29. Estimated life expectancy \< 24 months 30. Positive urine or serum pregnancy test in female subjects of childbearing potential 31. Currently participating in an investigational drug or another device study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success | Day 0 | The number of patients with procedural success, defined as freedom from all of the following at exit from the procedure room: * Mortality * Conversion to surgery * Moderate or severe paravalvular regurgitation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Vascular Complications | Discharge, expected to be within 1-5 days post-procedure] | Number of patients with major vascular complications |
| Valve Migration or Embolization | Discharge, expected to be within 1-5 days post-procedure] | Number of patients with valve migration or embolization |
Countries
Canada, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV: Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System. | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Transcatheter Aortic Valve Replacement (TAVR) | — |
|---|---|---|
| Age, Continuous | 83.5 years STANDARD_DEVIATION 6.27 | — |
| New York Heart Association (NYHA) Class Grouped Class I/II | 56 Participants | — |
| New York Heart Association (NYHA) Class Grouped Class III/IV | 44 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 50 Participants | — |
| Sex: Female, Male Male | 50 Participants | — |
| Society of Thoracic Surgeons (STS) Score | 3.6 units on a scale STANDARD_DEVIATION 1.29 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 100 |
| other Total, other adverse events | 14 / 100 |
| serious Total, serious adverse events | 28 / 100 |
Outcome results
Primary
Procedural Success
The number of patients with procedural success, defined as freedom from all of the following at exit from the procedure room: * Mortality * Conversion to surgery * Moderate or severe paravalvular regurgitation
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Procedural Success | 100 Participants |
Secondary
Major Vascular Complications
Number of patients with major vascular complications
Time frame: Discharge, expected to be within 1-5 days post-procedure]
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Major Vascular Complications | 2 Participants |
Secondary
Valve Migration or Embolization
Number of patients with valve migration or embolization
Time frame: Discharge, expected to be within 1-5 days post-procedure]
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Valve Migration or Embolization | 0 Participants |