Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
900 participants
INTERVENTIONAL
2020-11-12
2031-02-28
Brief Summary
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Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TMVR - Main Cohort
Subjects for whom commercially available surgical or transcatheter treatment options are deemed unsuitable will have transcatheter mitral valve replacement (TMVR).
SAPIEN M3 valve and dock
During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.
TMVR - Failed TEER Registry
Subjects who have had an attempted but failed transcatheter edge-to-edge repair (TEER) procedure will have TMVR.
SAPIEN M3 valve and dock
During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.
TMVR - MAC Registry
Subjects with mitral annular calcification (MAC) will have TMVR.
SAPIEN M3 valve and dock
During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.
Interventions
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SAPIEN M3 valve and dock
During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.
Eligibility Criteria
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Inclusion Criteria
2. MR ≥ 3+
3. NYHA functional class ≥ II
4. Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.
5. 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.
6. 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.
Exclusion Criteria
2. Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 dock and valve
3. Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation
4. Left ventricular ejection fraction \<25%
5. Severe right ventricular dysfunction
6. Need for aortic, tricuspid or pulmonic valve intervention within the next 12 months
7. History of heart transplant
8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
9. Active bacterial endocarditis within 180 days of the procedure
10. Hemodynamic instability requiring inotropic or mechanical support within 30 days of the procedure
11. Myocardial infarction within 30 days of the procedure
12. Clinically significant untreated coronary artery disease requiring revascularization
13. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the procedure
14. Stroke or transient ischemic attack within 90 days of the procedure
15. Irreversible, severe pulmonary hypertension
16. Chronic obstructive pulmonary disease requiring home oxygen therapy or chronic outpatient oral steroid use
17. Renal insufficiency or receiving renal replacement therapy
18. Liver disease
19. Planned surgery within the next 12 months
20. Inability to tolerate or a medical condition precluding treatment with antithrombotic therapy, including heparin administration during the procedure
21. Active infection requiring current antibiotic therapy
22. Active SARS-CoV-2 infection (Coronavirus-19 \[COVID-19\]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
23. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
24. Refusal of blood products
25. Female who is pregnant or lactating
26. Estimated life expectancy \<12 months due to non-cardiac conditions
27. Participating in another investigational drug or device study that has not reached its primary endpoint
28. Subject considered to be part of a vulnerable population
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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John Webb, MD
Role: PRINCIPAL_INVESTIGATOR
St. Paul's Hospital
Mayra Guerrero, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
David Daniels, MD
Role: PRINCIPAL_INVESTIGATOR
California Pacific Medical Center
Locations
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Heart Center Hospital
Huntsville, Alabama, United States
Banner University Medical Center
Phoenix, Arizona, United States
Saint Josephs Hospital Medical Center Dignity Health
Phoenix, Arizona, United States
TMC Healthcare
Tucson, Arizona, United States
Scripps Health
La Jolla, California, United States
Good Samaritan Hospital
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Kaiser Sunset LA
Los Angeles, California, United States
Saint Joseph Hospital
Orange, California, United States
California Pacific Medical Center
San Francisco, California, United States
UC Health Northern Colorado (Medical Center of the Rockies)
Loveland, Colorado, United States
Delray Medical Center
Delray Beach, Florida, United States
Cardiac & Vascular Institute Foundation
Gainesville, Florida, United States
Ascension St. Vincent's Hospital
Jacksonville, Florida, United States
Naples Community Hospital
Naples, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Emory University
Atlanta, Georgia, United States
Piedmont Healthcare
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Northshore University Health System
Glenview, Illinois, United States
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States
University of Kansas
Kansas City, Kansas, United States
Cardiovascular Research Institute of Kansas (CRIOK)
Wichita, Kansas, United States
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States
Medstar Union Memorial Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham & Women's
Boston, Massachusetts, United States
Henry Ford
Detroit, Michigan, United States
Minneapolis Heart
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
CentraCare
Saint Cloud, Minnesota, United States
Saint Luke's Kansas City
Kansas City, Missouri, United States
St. Patrick Hospital
Missoula, Montana, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Morristown Medical Center
Morristown, New Jersey, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
University of Buffalo
Buffalo, New York, United States
Weill Cornell Medicine
New York, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Novant Health and Vascular Institute
Charlotte, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Mount Carmel East Hospital
Columbus, Ohio, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
UPMC Heart and Vascular Institute
Mechanicsburg, Pennsylvania, United States
Alleghany General Hospital
Pittsburgh, Pennsylvania, United States
Saint Thomas Health
Nashville, Tennessee, United States
Austin Heart
Austin, Texas, United States
HCA Houston Healthcare Medical (SCRI)
Houston, Texas, United States
UT Memorial Hermann
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Sentara Norfolk
Norfolk, Virginia, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States
University of Washington Seattle
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
The Prince Charles Hospital
Chermside, Queensland, Australia
Royal Prince Alfred Hospital
Camperdown, , Australia
Laval University
Québec, Quebec, Canada
St. Michael's
Toronto, , Canada
St. Pauls
Vancouver, , Canada
Shaare Zedek Medical Center
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Leiden University Medical Center
Leiden, , Netherlands
Rotterdam Erasmus MC
Rotterdam, , Netherlands
Saint Bartholomew's Medical Center
London, , United Kingdom
Saint Thomas Hospital
London, , United Kingdom
Countries
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Central Contacts
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References
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Guerrero ME, Daniels DV, Makkar RR, Thourani VH, Asch FM, Pham M, Muhammad KI, Greenbaum AB, Vasquez A, Oldemeyer JB, Dahle TG, Rihal C, Morse MA, Rodriguez E, O'Neill BP, Russo M, Whisenant B, Yadav P, Yu X, Wang DD, Makar M, Baran DA, Mahoney P, Reddy G, Blanke P, Webb J; ENCIRCLE Trial Executive Committee and Study Investigators. Percutaneous transcatheter valve replacement in individuals with mitral regurgitation unsuitable for surgery or transcatheter edge-to-edge repair: a prospective, multicountry, single-arm trial. Lancet. 2025 Nov 29;406(10519):2541-2550. doi: 10.1016/S0140-6736(25)02073-2. Epub 2025 Oct 27.
Other Identifiers
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2018-19
Identifier Type: -
Identifier Source: org_study_id
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