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

NCT01808287 | Completed DMC

• 1 other identifier: 2012-07
• Study Type: interventional
• Target: 250
• Locations: 5 countries
• Sites: 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.

Conditions

Aortic Valve Disease

Keywords

Transcatheter Aortic Valve Replacement; Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• All-cause mortality rate

  NAP

  30 days post-index procedure

Secondary Outcomes (1)

• safety endpoints(VARC II)

  Discharge or 72 hours (whichever is longer), 30 days, 1 and 5 years post-index procedure.

Study Arms (2)

High risk population

EXPERIMENTAL

SAPIEN 3 transcatheter heart valve was implanted in high risk patients

Device: Edwards SAPIEN 3 Transcatheter Heart Valve

Intermediate risk population

EXPERIMENTAL

SAPIEN 3 transcatheter heart valve was implanted in intermediate risk patients

Device: Edwards SAPIEN 3 Transcatheter Heart Valve

Interventions

Edwards SAPIEN 3 Transcatheter Heart Valve 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).

Also known as: TAVR, TAVI

High risk population; Intermediate risk population

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Severe symptomatic calcific aortic valve stenosis with:
• High surgical risk: STS Score ≥ 8 or EuroSCORE ≥ 15 (first 50 patients),
• High to Intermediate surgical risk: STS Score ≥ 4 or EuroSCORE ≥ 10 (patients 51 to 150).
• 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).
• Age ≥ 75 years
• NYHA ≥ II
• Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate.
• Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits.

You may not qualify if:

• Non-calcified aortic valve
• Acute myocardial infarction ≤ 30 days before the intended treatment
• Untreated clinically significant coronary artery disease requiring revascularization.
• Aortic valve is a congenital unicuspid or congenital bicuspid valve.
• Mixed aortic valve disease (with predominant aortic regurgitation)
• Preexisting bioprosthetic valve or ring in any position

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (17)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1 Y6, Canada

Location

Laval, Institut universitaire de cardiologie et de pneumologie de Quebec

Laval, Quebec, G1V4G5, Canada

Location

Massy, Institut Jacques Cartier

Massy, 91300, France

Location

Paris, Hopital Bichat

Paris, 75018, France

Location

CHU Charles Nicolle

Rouen, 76031, France

Location

CHU Rangueil

Toulouse, 31059, France

Location

Kerckhoff Heartcenter

Bad Nauheim, 61231, Germany

Location

Universitatsklinik Koln

Cologne, 50937, Germany

Location

Universitatsklinik Essen

Essen, 45122, Germany

Location

Universitares Herzzentrum Hamburg GmbH

Hamburg, 20251, Germany

Location

Stadtisches Klinikum Kalsruhe

Karlsruhe, 76133, Germany

Location

Policlinico Universitario

Padua, 35128, Italy

Location

Royal Victoria Hospital

Belfast, BT12 6BA, United Kingdom

Location

London St. Thomas's Hospital

London, SE1 7EH, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Barts Health NHS Trust Hospital

London, W1G 8PH, United Kingdom

Location

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 27290682 RESULT

• 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.

  PMID: 25456759 DERIVED

MeSH Terms

Conditions

Aortic Valve Disease; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• John Webb, MD

  St. Paul's Hospital Vancouver (Canada)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: March 11, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 17, 2019
• Last Updated: April 1, 2020

Record last verified: 2020-03

Locations

IT (1); FR (4); DE (5); GB (5); CA (2)