The ENCIRCLE Trial

Recruiting now · Not applicable

Conditions studied: Mitral Regurgitation, Mitral Valve Insufficiency

In brief

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.

Key facts

Study ID

NCT04153292

Run by

Edwards Lifesciences

People needed

900

Starts

2020-11-12

Expected to finish

2031-02-28

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Mitral/cardiac anatomy that would preclude appropriate delivery and deployment of the SAPIEN M3 dock or valve
• Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 dock and valve
• Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation
• Left ventricular ejection fraction <25%
• Severe right ventricular dysfunction
• Need for aortic, tricuspid or pulmonic valve intervention within the next 12 months
• History of heart transplant
• Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
• Active bacterial endocarditis within 180 days of the procedure
• Hemodynamic instability requiring inotropic or mechanical support within 30 days of the procedure
• Myocardial infarction within 30 days of the procedure
• Clinically significant untreated coronary artery disease requiring revascularization
• Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the procedure
• Stroke or transient ischemic attack within 90 days of the procedure
• Irreversible, severe pulmonary hypertension
• Chronic obstructive pulmonary disease requiring home oxygen therapy or chronic outpatient oral steroid use
• Renal insufficiency or receiving renal replacement therapy
• Liver disease
• Planned surgery within the next 12 months
• Inability to tolerate or a medical condition precluding treatment with antithrombotic therapy, including heparin administration during the procedure
• Active infection requiring current antibiotic therapy
• Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
• Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
• Refusal of blood products
• Female who is pregnant or lactating

Where it is running

• St. Pauls — Vancouver, Canada (enrolling)
• St. Michael's — Toronto, Canada (enrolling)
• Laval University — Québec, Quebec, Canada (enrolling)
• Saint Josephs Hospital Medical Center Dignity Health — Phoenix, Arizona, United States
• Good Samaritan Hospital — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Scripps Health — La Jolla, 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
• Emory University — Atlanta, Georgia, United States
• Sarasota Memorial Hospital — Sarasota, Florida, 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
• Kaiser Sunset LA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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