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

Aortic Valve Disease Clinical Trial

— SAPIEN3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01808287
• Other study ID #: 2012-07
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 17, 2019

Study information

• Verified date: March 2020
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 17, 2019
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Aortic Valve Disease

Intervention

Device:
• Edwards SAPIEN 3 Transcatheter Heart Valve
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).

Locations

Country	Name	City	State
Canada	Laval, Institut universitaire de cardiologie et de pneumologie de Quebec	Laval	Quebec
Canada	St. Paul's Hospital	Vancouver	British Columbia
France	Massy, Institut Jacques Cartier	Massy
France	Paris, Hopital Bichat	Paris
France	CHU Charles Nicolle	Rouen
France	CHU Rangueil	Toulouse
Germany	Kerckhoff Heartcenter	Bad Nauheim
Germany	Universitatsklinik Essen	Essen
Germany	Universitares Herzzentrum Hamburg GmbH	Hamburg
Germany	Stadtisches Klinikum Kalsruhe	Karlsruhe
Germany	Universitatsklinik Koln	Koln
Italy	Policlinico Universitario	Padova
United Kingdom	Royal Victoria Hospital	Belfast
United Kingdom	Barts Health NHS Trust Hospital	London
United Kingdom	King's College Hospital	London
United Kingdom	London St. Thomas's Hospital	London
United Kingdom	Derriford Hospital	Plymouth

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Canada,  France,  Germany,  Italy,  United Kingdom, 

References & Publications (1)

Vahanian A, Urena M, Walther T, Treede H, Wendler O, Lefèvre T, Spence MS, Redwood S, Kahlert P, Rodes-Cabau J, Leipsic J, Webb J. Thirty-day outcomes in patients at intermediate risk for surgery from the SAPIEN 3 European approval trial. EuroIntervention — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality rate	NAP	30 days post-index procedure
Secondary	safety endpoints(VARC II)	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	Discharge or 72 hours (whichever is longer), 30 days, 1 and 5 years post-index procedure.