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

Not Applicable

Completed

• Conditions: Aortic Valve Disease
• Interventions: Device: Edwards SAPIEN 3 Transcatheter Heart Valve

• Registration Number: NCT01808287
• Lead Sponsor: Edwards Lifesciences

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-03-07
• Study First Submitted QC: 2013-03-07
• Study First Posted: 2013-03-11
• Primary Completion: 2013-12
• Study Completion: 2019-12-17
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermediate risk population	Edwards SAPIEN 3 Transcatheter Heart Valve	SAPIEN 3 transcatheter heart valve was implanted in intermediate risk patients
High risk population	Edwards SAPIEN 3 Transcatheter Heart Valve	SAPIEN 3 transcatheter heart valve was implanted in high risk patients

Primary Outcome Measures

Name	Time	Method
All-cause mortality rate	30 days post-index procedure	NAP

Secondary Outcome Measures

Name	Time	Method
safety endpoints(VARC II)	Discharge or 72 hours (whichever is longer), 30 days, 1 and 5 years post-index procedure.	safety endpoints; composite of mortality, and major complications including THV-related dysfunction major bleeds MI new conduction abnormality new onset of AF time-related valve safety composite of valve structural deterioration

Trial Locations

Locations (17)

Kerckhoff Heartcenter; 🇩🇪 Bad Nauheim, Germany

Policlinico Universitario; 🇮🇹 Padova, Italy

Universitatsklinik Koln; 🇩🇪 Koln, Germany

Royal Victoria Hospital; 🇬🇧 Belfast, United Kingdom

Universitares Herzzentrum Hamburg GmbH; 🇩🇪 Hamburg, Germany

Derriford Hospital; 🇬🇧 Plymouth, United Kingdom

Massy, Institut Jacques Cartier; 🇫🇷 Massy, France

Paris, Hopital Bichat; 🇫🇷 Paris, France

King's College Hospital; 🇬🇧 London, United Kingdom

Universitatsklinik Essen; 🇩🇪 Essen, Germany

London St. Thomas's Hospital; 🇬🇧 London, United Kingdom

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

CHU Charles Nicolle; 🇫🇷 Rouen, France

CHU Rangueil; 🇫🇷 Toulouse, France

Stadtisches Klinikum Kalsruhe; 🇩🇪 Karlsruhe, Germany

Barts Health NHS Trust Hospital; 🇬🇧 London, United Kingdom

Laval, Institut universitaire de cardiologie et de pneumologie de Quebec; 🇨🇦 Laval, Quebec, Canada