Aortic Valve Stenosis
Conditions
Keywords
THV, Transcatheter Heart Valve, CENTERA, self-expanding
Brief summary
This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement (SAVR).
Detailed description
A prospective, single-arm, controlled, multicenter study. Up to 2 roll-ins were allowed per site but not counted towards total enrollment.
Interventions
DEVICETAVR with CENTERA THV
TAVR with the Edwards CENTERA THV System
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Severe, calcific AS 2. NYHA 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 sizes 23, 26 or 29 mm CENTERA THV based on 3D imaging analysis 2. Aortic valve is unicuspid, bicuspid or non-calcified 3. Pre-existing mechanical or bioprosthetic valve in any position 4. Known hypersensitivity to Nitinol (nickel or titanium) 5. Severe aortic regurgitation (\> 3+) 6. Severe mitral regurgitation (\> 3+) or ≥ moderate stenosis 7. Ventricular dysfunction with left ventricular ejection fraction \< 30% 8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation 9. Evidence of an acute myocardial infarction ≤ 30 days before the valve implant procedure 10. Subjects with planned concomitant ablation for atrial fibrillation 11. Hypertrophic cardiomyopathy with obstruction 12. Coronary anatomy that increases the risk of coronary artery obstruction post-TAVR 13. Complex coronary artery disease 14. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath. 15. Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system 16. Active bacterial endocarditis within 180 days of the valve implant procedure 17. Stroke or transient ischemic attack within 90 days of the valve implant procedure 18. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of the valve implant procedure 19. Severe lung disease or currently on home oxygen 20. Severe pulmonary hypertension 21. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the valve implant procedure 22. History of cirrhosis or any active liver disease 23. Renal insufficiency and/or renal replacement therapy at the time of screening 24. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states 25. Inability to tolerate or condition precluding treatment with antithrombotic therapy during or after the valve implant procedure 26. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication 27. Significant frailty as determined by the Heart Team 28. Immobility that would prevent completion of study procedures 29. Subject refuses blood products 30. Body mass index \> 50 kg/m2 31. Estimated life expectancy \< 24 months 32. Positive urine or serum pregnancy test in female subjects of childbearing potential 33. Currently participating in an investigational drug or another device study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause Death | 1 year | Number of participants that died |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Edwards CENTERA System TAVR Transcatheter aortic valve replacement (TAVR) with the Edwards CENTERA THV System | 101 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Did not receive study valve. | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Edwards CENTERA System TAVR |
|---|---|
| Age, Continuous | 80.0 years STANDARD_DEVIATION 6.32 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 91 Participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 101 |
| other Total, other adverse events | 44 / 101 |
| serious Total, serious adverse events | 46 / 101 |
Outcome results
Primary
All-cause Death
Number of participants that died
Time frame: 1 year
Population: All enrolled participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Edwards CENTERA System TAVR | All-cause Death | 3 Participants |