SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation

Mitral Regurgitation Clinical Trial

— SAPIEN M3 EFS  

Official title:

Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03230747
• Other study ID #: 2017-03
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Mitral Disease
• Mitral Regurgitation
• Mitral Valve Insufficiency

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