NCT03230747CompletedNot Applicable
Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
Edwards Lifesciences9 sites in 2 countries72 target enrollmentStarted: September 14, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 72
- Locations
- 9
- Primary Endpoint
- Technical Success
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years of age or older
- •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 Criteria
- •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
Arms & Interventions
TMVR
Experimental
Subjects will undergo transcatheter mitral valve replacement
Intervention: Edwards SAPIEN M3 System (Device)
Outcomes
Primary Outcomes
Technical Success
Time Frame: 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 Outcomes
- Reduction in mitral regurgitation (MR)(30 Days)
Investigators
Study Sites (9)
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