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RECRUITING

NCT04153292

The ENCIRCLE Trial

Sponsor: Edwards Lifesciences

View on ClinicalTrials.gov

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.

Official title: SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

900

Start Date

2020-11-12

Completion Date

2031-02-28

Last Updated

2026-02-25

Healthy Volunteers

Conditions

Mitral Regurgitation Mitral Valve Insufficiency

Interventions

DEVICE

SAPIEN M3 valve and dock

During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.

Inclusion Criteria: 1. 18 years of age or older 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: 1. Mitral/cardiac anatomy that would preclude appropriate delivery and deployment of the SAPIEN M3 dock or valve 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

Locations (68)

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

Clinical Research Directory

The ENCIRCLE Trial

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (68)