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

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Disease
• Intervention / Treatment: Device: Edwards SAPIEN 3 Transcatheter Heart Valve

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 Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1 Y6
      • St. Paul's Hospital
  • Quebec
    • Laval, Quebec, Canada, G1V4G5
      • Laval, Institut universitaire de cardiologie et de pneumologie de Quebec
• France
  • Massy, France, 91300
    • Massy, Institut Jacques Cartier
  • Paris, France, 75018
    • Paris, Hopital Bichat
  • Rouen, France, 76031
    • CHU Charles Nicolle
  • Toulouse, France, 31059
    • CHU Rangueil
• Germany
  • Bad Nauheim, Germany, 61231
    • Kerckhoff Heartcenter
  • Essen, Germany, 45122
    • Universitätsklinik Essen
  • Hamburg, Germany, 20251
    • Universitäres Herzzentrum Hamburg GmbH
  • Karlsruhe, Germany, 76133
    • Stadtisches Klinikum Kalsruhe
  • Koln, Germany, 50937
    • Universitätsklinik Köln
• Italy
  • Padova, Italy, 35128
    • Policlinico Universitario
• United Kingdom
  • Belfast, United Kingdom, BT12 6BA
    • Royal Victoria Hospital
  • London, United Kingdom, SE5 9RS
    • King's College Hospital
  • London, United Kingdom, SE1 7EH
    • London St. Thomas's Hospital
  • London, United Kingdom, W1G 8PH
    • Barts Health NHS Trust Hospital
  • Plymouth, United Kingdom, PL6 8DH
    • Derriford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 71 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High risk population; SAPIEN 3 transcatheter heart valve was implanted in high risk patients	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).; Other Names: TAVI; TAVR
Experimental: Intermediate risk population; SAPIEN 3 transcatheter heart valve was implanted in intermediate risk patients	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).; Other Names: TAVI; TAVR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality rate	NAP	30 days post-index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: John Webb, MD, St. Paul's Hospital Vancouver (Canada)

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 17, 2019

Study Registration Dates

• First Submitted: March 7, 2013
• First Submitted That Met QC Criteria: March 7, 2013
• First Posted (Estimate): March 11, 2013

Study Record Updates

• Last Update Posted (Actual): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Aortic Stenosis; Transcatheter Aortic Valve Replacement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: 2012-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No