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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03230747
Other study ID # 2017-03
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 14, 2017
Est. completion date August 2027

Study information

Verified date June 2023
Source Edwards Lifesciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Prospective, single-arm, multicenter early feasibility study


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 74
Est. completion date August 2027
Est. primary completion date June 16, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Device:
Edwards SAPIEN M3 System
SAPIEN M3 System includes the SAPIEN M3 valve and the SAPIEN M3 dock

Locations

Country Name City State
Canada St. Paul's Hospital Vancouver British Columbia
United States Emory University Atlanta Georgia
United States Henry Ford Hospital Detroit Michigan
United States Evanston/ Northshore University Evanston Illinois
United States Cedars-Sinai Medical Center Heart Institute Los Angeles California
United States Intermountain Medical Center Murray Utah
United States Sentara Cardiovascular Research Institution Norfolk Virginia
United States Mayo Clinic Rochester Minnesota
United States California Pacific Medical Center San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Reduction in mitral regurgitation (MR) Reduction in MR to 0 or 1+ 30 Days
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