SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation

NAActive, not recruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

September 14, 2017

Primary Completion Date

June 16, 2021

Study Completion Date

August 31, 2027

Conditions
Mitral RegurgitationMitral Disease
Interventions
DEVICE

Edwards SAPIEN M3 System

SAPIEN M3 System includes the SAPIEN M3 valve and the SAPIEN M3 dock

Trial Locations (9)

23507

Sentara Cardiovascular Research Institution, Norfolk

30308

Emory University, Atlanta

48202

Henry Ford Hospital, Detroit

55905

Mayo Clinic, Rochester

60201

Evanston/ Northshore University, Evanston

84107

Intermountain Medical Center, Murray

90048

Cedars-Sinai Medical Center Heart Institute, Los Angeles

94109

California Pacific Medical Center, San Francisco

V62146

St. Paul's Hospital, Vancouver

Sponsors
All Listed Sponsors
lead

Edwards Lifesciences

INDUSTRY