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

NCT ID: NCT01808287

Last Updated: 2020-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2019-12-17

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.

Conditions

Aortic Valve Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High risk population

SAPIEN 3 transcatheter heart valve was implanted in high risk patients

Group Type: EXPERIMENTAL

Edwards SAPIEN 3 Transcatheter Heart Valve

Intervention Type: DEVICE

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).

Intermediate risk population

SAPIEN 3 transcatheter heart valve was implanted in intermediate risk patients

Group Type: EXPERIMENTAL

Edwards SAPIEN 3 Transcatheter Heart Valve

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

TAVR; TAVI

Eligibility Criteria

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).

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Webb, MD

Role: PRINCIPAL_INVESTIGATOR

St. Paul's Hospital Vancouver (Canada)

Locations

St. Paul's Hospital

Vancouver, British Columbia, Canada

Laval, Institut universitaire de cardiologie et de pneumologie de Quebec

Laval, Quebec, Canada

Massy, Institut Jacques Cartier

Massy, , France

Paris, Hopital Bichat

Paris, , France

CHU Charles Nicolle

Rouen, , France

CHU Rangueil

Toulouse, , France

Kerckhoff Heartcenter

Bad Nauheim, , Germany

Universitatsklinik Koln

Cologne, , Germany

Universitatsklinik Essen

Essen, , Germany

Universitares Herzzentrum Hamburg GmbH

Hamburg, , Germany

Stadtisches Klinikum Kalsruhe

Karlsruhe, , Germany

Policlinico Universitario

Padua, , Italy

Royal Victoria Hospital

Belfast, , United Kingdom

London St. Thomas's Hospital

London, , United Kingdom

King's College Hospital

London, , United Kingdom

Barts Health NHS Trust Hospital

London, , United Kingdom

Derriford Hospital

Plymouth, , United Kingdom

Countries

Canada; France; Germany; Italy; United Kingdom

References

Vahanian A, Urena M, Walther T, Treede H, Wendler O, Lefevre 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. 2016 Jun 12;12(2):e235-43. doi: 10.4244/EIJV12I2A37.

Reference Type: RESULT

PMID: 27290682 (View on PubMed)

Webb J, Gerosa G, Lefevre T, Leipsic J, Spence M, Thomas M, Thielmann M, Treede H, Wendler O, Walther T. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014 Dec 2;64(21):2235-43. doi: 10.1016/j.jacc.2014.09.026. Epub 2014 Nov 24.

Reference Type: DERIVED

PMID: 25456759 (View on PubMed)

Other Identifiers

2012-07

Identifier Type: -

Identifier Source: org_study_id