Status:
ACTIVE_NOT_RECRUITING
SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
Lead Sponsor:
Edwards Lifesciences
Conditions:
Mitral Regurgitation
Mitral Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 M...
Detailed Description
Prospective, single-arm, multicenter early feasibility study
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Participating in another investigational drug or device study
Key Trial Info
Start Date :
September 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2027
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03230747
Start Date
September 14 2017
End Date
August 1 2027
Last Update
July 22 2025
Active Locations (9)
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1
Cedars-Sinai Medical Center Heart Institute
Los Angeles, California, United States, 90048
2
California Pacific Medical Center
San Francisco, California, United States, 94109
3
Emory University
Atlanta, Georgia, United States, 30308
4
Evanston/ Northshore University
Evanston, Illinois, United States, 60201