SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access
Status: Recruiting
Location: See all (68) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 18 years of age or older
• MR ≥ 3+
• NYHA functional class ≥ II
• Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.
• Subject's heart failure management has been optimized based on subject characteristics and applicable guidelines, and stable for at least 30 days prior to enrollment.
• The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Locations
United States
Alabama
Heart Center Hospital
RECRUITING
Huntsville
Arizona
Banner University Medical Center
RECRUITING
Phoenix
Saint Josephs Hospital Medical Center Dignity Health
RECRUITING
Phoenix
TMC Healthcare
WITHDRAWN
Tucson
California
Scripps Health
RECRUITING
La Jolla
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Good Samaritan Hospital
RECRUITING
Los Angeles
Kaiser Sunset LA
ACTIVE_NOT_RECRUITING
Los Angeles
Saint Joseph Hospital
WITHDRAWN
Orange
California Pacific Medical Center
RECRUITING
San Francisco
Colorado
UC Health Northern Colorado (Medical Center of the Rockies)
RECRUITING
Loveland
Florida
Delray Medical Center
WITHDRAWN
Delray Beach
Cardiac & Vascular Institute Foundation
ACTIVE_NOT_RECRUITING
Gainesville
Ascension St. Vincent's Hospital
ACTIVE_NOT_RECRUITING
Jacksonville
Naples Community Hospital
RECRUITING
Naples
Sarasota Memorial Hospital
RECRUITING
Sarasota
Georgia
Emory University
RECRUITING
Atlanta
Piedmont Healthcare
RECRUITING
Atlanta
Illinois
Rush University Medical Center
WITHDRAWN
Chicago
Northshore University Health System
RECRUITING
Glenview
Indiana
St. Vincent Heart Center of Indiana
WITHDRAWN
Indianapolis
Kansas
University of Kansas
RECRUITING
Kansas City
Cardiovascular Research Institute of Kansas (CRIOK)
RECRUITING
Wichita
Louisiana
Our Lady of the Lake Regional Medical Center
RECRUITING
Baton Rouge
Massachusetts
Brigham & Women's
WITHDRAWN
Boston
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Medstar Union Memorial Hospital
RECRUITING
Baltimore
Michigan
Henry Ford
RECRUITING
Detroit
Minnesota
Minneapolis Heart
WITHDRAWN
Minneapolis
Mayo Clinic
RECRUITING
Rochester
CentraCare
RECRUITING
Saint Cloud
Missouri
Saint Luke's Kansas City
ACTIVE_NOT_RECRUITING
Kansas City
Montana
St. Patrick Hospital
WITHDRAWN
Missoula
North Carolina
Carolinas Medical Center
WITHDRAWN
Charlotte
Novant Health and Vascular Institute
RECRUITING
Charlotte
New Hampshire
Dartmouth-Hitchcock Medical Center
RECRUITING
Lebanon
New Jersey
Morristown Medical Center
WITHDRAWN
Morristown
Robert Wood Johnson University Hospital
RECRUITING
New Brunswick
New York
University of Buffalo
RECRUITING
Buffalo
Weill Cornell Medicine
RECRUITING
New York
Ohio
The Christ Hospital
RECRUITING
Cincinnati
Cleveland Clinic Foundation
RECRUITING
Cleveland
Mount Carmel East Hospital
ACTIVE_NOT_RECRUITING
Columbus
Oklahoma
Oklahoma Heart Hospital
RECRUITING
Oklahoma City
Oklahoma Heart Institute
RECRUITING
Tulsa
Pennsylvania
UPMC Heart and Vascular Institute
ACTIVE_NOT_RECRUITING
Mechanicsburg
Alleghany General Hospital
WITHDRAWN
Pittsburgh
Tennessee
Saint Thomas Health
RECRUITING
Nashville
Texas
Austin Heart
RECRUITING
Austin
HCA Houston Healthcare Medical (SCRI)
ACTIVE_NOT_RECRUITING
Houston
UT Memorial Hermann
ACTIVE_NOT_RECRUITING
Houston
Utah
Intermountain Medical Center
RECRUITING
Murray
Virginia
Sentara Norfolk
RECRUITING
Norfolk
Carilion Roanoke Memorial Hospital
RECRUITING
Roanoke
Washington
University of Washington Seattle
ACTIVE_NOT_RECRUITING
Seattle
Wisconsin
University of Wisconsin
WITHDRAWN
Madison
Other Locations
Australia
Royal Prince Alfred Hospital
ACTIVE_NOT_RECRUITING
Camperdown
The Prince Charles Hospital
ACTIVE_NOT_RECRUITING
Chermside
Canada
Laval University
RECRUITING
Québec
St. Michael's
RECRUITING
Toronto
St. Pauls
RECRUITING
Vancouver
Israel
Shaare Zedek Medical Center
WITHDRAWN
Jerusalem
Rabin Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
WITHDRAWN
Ramat Gan
Netherlands
Leiden University Medical Center
RECRUITING
Leiden
Rotterdam Erasmus MC
RECRUITING
Rotterdam
United Kingdom
Saint Thomas Hospital
RECRUITING
London
Saint Bartholomew's Medical Center
RECRUITING
Oxford
Contact Information
Primary
Edwards THV Clinical Affairs
THV_CT.gov@Edwards.com
+1 (949) 250-2500
Time Frame
Start Date: 2020-11-12
Estimated Completion Date: 2031-02
Participants
Target number of participants: 900
Treatments
Experimental: TMVR - Main Cohort
Subjects for whom commercially available surgical or transcatheter treatment options are deemed unsuitable will have transcatheter mitral valve replacement (TMVR).
Experimental: TMVR - Failed TEER Registry
Subjects who have had an attempted but failed transcatheter edge-to-edge repair (TEER) procedure will have TMVR.
Experimental: TMVR - MAC Registry
Subjects with mitral annular calcification (MAC) will have TMVR.
Related Therapeutic Areas
Sponsors
Leads: Edwards Lifesciences