Mitral Disease, Mitral Regurgitation
Conditions
Keywords
Transcatheter Mitral Valve Replacement, SAPIEN M3
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
Interventions
DEVICEEdwards SAPIEN M3 System
SAPIEN M3 System includes the SAPIEN M3 valve and the SAPIEN M3 dock
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Reduction in mitral regurgitation (MR) | 30 Days | Reduction in MR to 0 or 1+ |
Countries
Canada, United States
Outcome results
None listed