Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study (SAPIEN3)

Edwards Lifesciences

Status: Completed

Conditions: Aortic Valve Disease

Treatments: Device: Edwards SAPIEN 3 Transcatheter Heart Valve

Study type: Interventional

Funder types: Industry

Identifiers

NCT01808287

2012-07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

High risk population

Experimental group

Description:

SAPIEN 3 transcatheter heart valve was implanted in high risk patients

Treatment:

Device: Edwards SAPIEN 3 Transcatheter Heart Valve

Intermediate risk population

Experimental group

Description:

SAPIEN 3 transcatheter heart valve was implanted in intermediate risk patients

Treatment:

Device: Edwards SAPIEN 3 Transcatheter Heart Valve