Status:
RECRUITING
TVMR With the INNOVALVE System Trial - Early Feasibility Study
Lead Sponsor:
Edwards Lifesciences
Conditions:
Mitral Valve Regurgitation (Degenerative or Functional)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Study to evaluate the safety and performance of the INNOVALVE system
Detailed Description
The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the INNOVALVE system
Eligibility Criteria
Inclusion
- Clinically significant, symptomatic mitral regurgitation
- High risk for open-heart surgery
- Meets anatomical criteria
Exclusion
- Unsuitable anatomy
- Patient is inoperable
- EF\<25%
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2031
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04919980
Start Date
September 1 2022
End Date
July 1 2031
Last Update
October 23 2025
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Cedars-Sinai
Los Angeles, California, United States, 90048
2
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
3
University of Michigan Hospital and Health Systems
Ann Arbor, Michigan, United States, 48109
4
Mayo Clinic
Rochester, Minnesota, United States, 555905