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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Mitral Regurgitation; Mitral Disease
• Intervention / Treatment: Device: Edwards SAPIEN M3 System

Detailed Description

Prospective, single-arm, multicenter early feasibility study

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V62146
      • St. Paul's Hospital
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center Heart Institute
    • San Francisco, California, United States, 94109
      • California Pacific Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Evanston/ Northshore University
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Cardiovascular Research Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 years of age or older
2. MR ≥ 3+
3. NYHA functional class ≥ II
4. High risk of cardiovascular surgery
5. Hemodynamically stable while on heart failure medication for at least 2 weeks before the procedure
6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

1. Mitral anatomy that would preclude appropriate delivery and deployment of the dock or valve
2. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
3. Significant risk of LVOT obstruction
4. Severe right ventricular dysfunction
5. LV Ejection Fraction <30%
6. Patient is inoperable
7. Prior surgical or interventional treatment of mitral valve preventing appropriate device access and deployment
8. Need for aortic, tricuspid or pulmonic valve replacement
9. Presence of mechanical aortic valve prosthesis
10. History of cardiac transplantation
11. History of recurrent and/or unprovoked deep vein thrombosis or pulmonary embolism
12. Clinically significant untreated coronary artery disease requiring revascularization
13. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days.
14. Stroke or transient ischemic attack within 90 days of the procedure
15. Myocardial infarction within 30 days of the procedure
16. Active bacterial endocarditis within 180 days of the procedure
17. Inability to tolerate or a medical condition precluding treatment with anti-thrombotic therapy
18. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states
19. Hospitalization for CHF or hemodynamic instability requiring inotropic support or intra-aortic balloon pump within 30 days.
20. Irreversible, severe pulmonary hypertension
21. Patients with renal insufficiency or receiving renal replacement therapy
22. Liver disease or significantly abnormal liver function test results
23. Refusal of blood products
24. Female who is pregnant or lactating
25. Estimated life expectancy < 12 months
26. Participating in another investigational drug or device study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TMVR; Subjects will undergo transcatheter mitral valve replacement	Device: Edwards SAPIEN M3 System; SAPIEN M3 System includes the SAPIEN M3 valve and the SAPIEN M3 dock

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	Defined as meeting all the following: Alive; Successful access, delivery and retrieval of the delivery systems; Deployment of the devices in the intended position; Freedom from emergency surgery or reintervention related to the device or access procedure	At the end of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in mitral regurgitation (MR)	Reduction in MR to 0 or 1+	30 Days

Collaborators and Investigators

• Sponsor: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2017
• Primary Completion (Actual): June 16, 2021
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 26, 2017

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Transcatheter Mitral Valve Replacement; SAPIEN M3
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: 2017-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes