SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
- Conditions
- Mitral DiseaseMitral Regurgitation
- Registration Number
- NCT03230747
- Lead Sponsor
- Edwards Lifesciences
- 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 M3 System.
- Detailed Description
Prospective, single-arm, multicenter early feasibility study
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 72
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Technical Success At the end of the procedure 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
- Secondary Outcome Measures
Name Time Method Reduction in mitral regurgitation (MR) 30 Days Reduction in MR to 0 or 1+
Trial Locations
- Locations (9)
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
Cedars-Sinai Medical Center Heart Institute🇺🇸Los Angeles, California, United States