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

Running, not enrolling · Not applicable

Conditions studied: Mitral Regurgitation, Mitral Disease

In brief

This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System.

Key facts

Study ID

NCT03230747

Run by

Edwards Lifesciences

People needed

72

Starts

2017-09-14

Expected to finish

2027-08-31

Last updated by the study team

2026-07-17

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
• High risk of cardiovascular surgery
• Hemodynamically stable while on heart failure medication for at least 2 weeks before the procedure
• The study patient 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 anatomy that would preclude appropriate delivery and deployment of the dock or valve
• Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
• Significant risk of LVOT obstruction
• Severe right ventricular dysfunction
• LV Ejection Fraction <30%
• Patient is inoperable
• Prior surgical or interventional treatment of mitral valve preventing appropriate device access and deployment
• Need for aortic, tricuspid or pulmonic valve replacement
• Presence of mechanical aortic valve prosthesis
• History of cardiac transplantation
• History of recurrent and/or unprovoked deep vein thrombosis or pulmonary embolism
• Clinically significant untreated coronary artery disease requiring revascularization
• Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days.
• Stroke or transient ischemic attack within 90 days of the procedure
• Myocardial infarction within 30 days of the procedure
• Active bacterial endocarditis within 180 days of the procedure
• Inability to tolerate or a medical condition precluding treatment with anti-thrombotic therapy
• Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states
• Hospitalization for CHF or hemodynamic instability requiring inotropic support or intra-aortic balloon pump within 30 days.
• Irreversible, severe pulmonary hypertension
• Patients with renal insufficiency or receiving renal replacement therapy
• Liver disease or significantly abnormal liver function test results
• Refusal of blood products
• Female who is pregnant or lactating
• Estimated life expectancy < 12 months

Where it is running

• Cedars-Sinai Medical Center Heart Institute — Los Angeles, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Emory University — Atlanta, Georgia, United States
• Evanston/ Northshore University — Evanston, Illinois, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Intermountain Medical Center — Murray, Utah, United States
• Sentara Cardiovascular Research Institution — Norfolk, Virginia, United States
• St. Paul's Hospital — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.