Overview

This trial is active, not recruiting.

Condition aortic valve disease
Treatment edwards sapien 3 transcatheter heart valve
Sponsor Edwards Lifesciences
Collaborator C5 Research (Cleveland Clinical Coordinating Center for Clinical Research)
Start date January 2013
End date December 2013
Trial size 250 participants
Trial identifier NCT01808287, 2012-07

Summary

The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
All-cause mortality rate
time frame: 30 days post-index procedure

Secondary Outcomes

Measure
device success(VARC II) safety endpoints(VARC II) echocardiography endpoints(VARCII)
time frame: Discharge or 72 hours (whichever is longer), 30 days, 1 and 5 years post-index procedure.

Eligibility Criteria

Male or female participants at least 75 years old.

Inclusion Criteria: 1. Severe symptomatic calcific aortic valve stenosis with: 1. High surgical risk: STS Score ≥ 8 or EuroSCORE ≥ 15 (first 50 patients), 2. High to Intermediate surgical risk: STS Score ≥ 4 or EuroSCORE ≥ 10 (patients 51 to 150). 3. Intermediate surgical risk: STS Score 4 to 8 or Logistic EuroSCORE 10 to 15 (subsequent patients); except for 20mm valve implants (STS Score > 4 or EuroSCORE ≥ 10) 2. Age ≥ 75 years. 3. NYHA ≥ II 4. AVA< 1cm2 and mean gradient > 40mmHg 5. Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate 6. Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits Exclusion Criteria: 1. Non-calcified aortic valve 2. Acute myocardial infarction ≤ 30 days before the intended treatment 3. Untreated clinically significant coronary artery disease requiring revascularization. 4. Aortic valve is a congenital unicuspid or congenital bicuspid valve. 5. Mixed aortic valve disease (with predominant aortic regurgitation) 6. Preexisting bioprosthetic valve or ring in any position 7. Leukopenia, anemia, thrombocytopenia 8. Hypertrophic cardiomyopathy with or without obstruction 9. Severe ventricular dysfunction with LVEF < 20% 10. Echocardiographic evidence of intracardiac mass, thrombus or vegetation 11. Active upper GI bleeding within 90 days prior to procedure 12. known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure 13. Native aortic annulus size : 1. < 18 mm or > 25 mm as measured by TEE, 23 and 26mm valves 2. > 27mm as measured by TEE, 29mm valve 3. < 16mm as measured by TEE, 20mm valve 14. Clinically (by neurologist) or neuroimaging confirmed stroke or TIA within 90 days of the procedure 15. Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the time of screening 16. Estimated life expectancy < 24 months 17. Expectation that patient will not improve despite treatment of aortic stenosis 18. Currently participating in an investigational drug or another device study 19. Active bacterial endocarditis within 180 days of procedure 20. Known hypersensitivity to contrast media, chromium, nickel, molybdenum, manganese, copper, silicon, and/or polymeric materials 21. Any neurologic disease which severely affects the ability to walk or perform everyday activities 22. Senile dementia 23. For Intermediate Risk patients enrolled under inclusion criterion 1.c) patients with untreated pre-existing conduction disturbances (AV Block and Bundle Branch Block).

Additional Information

Official title Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve
Principal investigator John Webb, MD
Description This is a non-randomized, prospective, multicenter safety and device success study. Two hundred fifty (250) patients are planned to be enrolled at up to 20 participating investigational centers in Europe and Canada. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, hospital discharge, 30 days, 1 year and annually thereafter for a minimum of 5 years.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Edwards Lifesciences.