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

Primary Purpose

Aortic Valve Disease

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Edwards SAPIEN 3 Transcatheter Heart Valve

About this trial

This is an interventional treatment trial for Aortic Valve Disease focused on measuring Transcatheter Aortic Valve Replacement, Aortic Stenosis

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).
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.

Exclusion Criteria:

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
For Intermediate Risk patients enrolled under inclusion criterion 1.c) patients with untreated pre-existing conduction disturbances (AV Block and Bundle Branch Block).

Sites / Locations

St. Paul's Hospital
Laval, Institut universitaire de cardiologie et de pneumologie de Quebec
Massy, Institut Jacques Cartier
Paris, Hopital Bichat
CHU Charles Nicolle
CHU Rangueil
Kerckhoff Heartcenter
Universitatsklinik Essen
Universitares Herzzentrum Hamburg GmbH
Stadtisches Klinikum Kalsruhe
Universitatsklinik Koln
Policlinico Universitario
Royal Victoria Hospital
London St. Thomas's Hospital
King's College Hospital
Barts Health NHS Trust Hospital
Derriford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

High risk population

Intermediate risk population

Arm Description

SAPIEN 3 transcatheter heart valve was implanted in high risk patients

SAPIEN 3 transcatheter heart valve was implanted in intermediate risk patients

Outcomes

Primary Outcome Measures

All-cause mortality rate

NAP

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01808287

First Posted

March 7, 2013

Last Updated

March 31, 2020

Sponsor

Edwards Lifesciences

1. Study Identification

Unique Protocol Identification Number

NCT01808287

Brief Title

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

Acronym

SAPIEN3

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

January 2013 (Actual)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Disease

Keywords

Transcatheter Aortic Valve Replacement, Aortic Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

250 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High risk population

Arm Type

Experimental

Arm Description

SAPIEN 3 transcatheter heart valve was implanted in high risk patients

Arm Title

Intermediate risk population

Arm Type

Experimental

Arm Description

SAPIEN 3 transcatheter heart valve was implanted in intermediate risk patients

Intervention Type

Device

Intervention Name(s)

Edwards SAPIEN 3 Transcatheter Heart Valve

Other Intervention Name(s)

TAVR, TAVI

Intervention Description

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).

Primary Outcome Measure Information:

Title

All-cause mortality rate

Description

NAP

Time Frame

30 days post-index procedure

Secondary Outcome Measure Information:

Title

safety endpoints(VARC II)

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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 For Intermediate Risk patients enrolled under inclusion criterion 1.c) patients with untreated pre-existing conduction disturbances (AV Block and Bundle Branch Block).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Webb, MD

Organizational Affiliation

St. Paul's Hospital Vancouver (Canada)

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Paul's Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 1 Y6

Country

Canada

Facility Name

Laval, Institut universitaire de cardiologie et de pneumologie de Quebec

City

Laval

State/Province

Quebec

ZIP/Postal Code

G1V4G5

Country

Canada

Facility Name

Massy, Institut Jacques Cartier

City

Massy

ZIP/Postal Code

91300

Country

France

Facility Name

Paris, Hopital Bichat

City

Paris

ZIP/Postal Code

75018

Country

France

Facility Name

CHU Charles Nicolle

City

Rouen

ZIP/Postal Code

76031

Country

France

Facility Name

CHU Rangueil

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Kerckhoff Heartcenter

City

Bad Nauheim

ZIP/Postal Code

61231

Country

Germany

Facility Name

Universitatsklinik Essen

City

Essen

ZIP/Postal Code

45122

Country

Germany

Facility Name

Universitares Herzzentrum Hamburg GmbH

City

Hamburg

ZIP/Postal Code

20251

Country

Germany

Facility Name

Stadtisches Klinikum Kalsruhe

City

Karlsruhe

ZIP/Postal Code

76133

Country

Germany

Facility Name

Universitatsklinik Koln

City

Koln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Policlinico Universitario

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Royal Victoria Hospital

City

Belfast

ZIP/Postal Code

BT12 6BA

Country

United Kingdom

Facility Name

London St. Thomas's Hospital

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Facility Name

King's College Hospital

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Barts Health NHS Trust Hospital

City

London

ZIP/Postal Code

W1G 8PH

Country

United Kingdom

Facility Name

Derriford Hospital

City

Plymouth

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

27290682

Citation

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.

Results Reference

result

PubMed Identifier

25456759

Citation

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.

Results Reference

derived

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

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