Overview

This trial is active, not recruiting.

Condition aortic valve disease
Treatment edwards sapien 3 transcatheter heart valve
Sponsor Edwards Lifesciences
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

Allocation non-randomized
Intervention model parallel assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
SAPIEN 3 transcatheter heart valve was implanted in high risk patients
edwards sapien 3 transcatheter heart valve TAVR
The Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (intermediate or higher operable risk) with severe aortic stenosis requiring aortic valve replacement (AVR).
(Experimental)
SAPIEN 3 transcatheter heart valve was implanted in intermediate risk patients
edwards sapien 3 transcatheter heart valve TAVR
The Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (intermediate or higher operable risk) with severe aortic stenosis requiring aortic valve replacement (AVR).

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

All 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. Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate. 5. 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. 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 February 2017.
Information provided to ClinicalTrials.gov by Edwards Lifesciences.