TVMR With the INNOVALVE System Trial - Early Feasibility Study
TWIST-EFS
1 other identifier
interventional
85
1 country
21
Brief Summary
Study to evaluate the safety and performance of the INNOVALVE system
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
Longer than P75 for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2021
CompletedFirst Posted
Study publicly available on registry
June 9, 2021
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2034
September 21, 2026
September 1, 2026
5.8 years
June 3, 2021
September 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Serious adverse events (SAE) through 30 days post-procedure
Serious adverse events (SAE) through 30 days post-procedure
30 days
Secondary Outcomes (6)
Technical success
Procedure
Procedural success
30 days
NYHA functional class
30 days, 6, 12 months and annually up to 5 years
Six-minute walk test
30 days, 6, 12 months and annually up to 5 years
Quality of life improvement (KCCQ-12)
30 days, 6, 12 months and annually up to 5 years
- +1 more secondary outcomes
Study Arms (1)
Treatment
EXPERIMENTALMV replacement with INNOVALVE system
Interventions
Eligibility Criteria
You may qualify if:
- Clinically significant, symptomatic mitral regurgitation
- High risk for open-heart surgery
- Meets anatomical criteria
You may not qualify if:
- Unsuitable anatomy
- Patient is inoperable
- EF\<25%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Cedars-Sinai
Los Angeles, California, 90048, United States
Stanford University
Palo Alto, California, 94305, United States
Naples Comprehensive Health
Naples, Florida, 34102, United States
Emory University
Atlanta, Georgia, 30308, United States
Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
Northwestern
Chicago, Illinois, 60611, United States
University of Michigan Hospital and Health Systems
Ann Arbor, Michigan, 48109, United States
Henry Ford Health
Detroit, Michigan, 48202, United States
Mayo Clinic
Rochester, Minnesota, 555905, United States
Saint Luke's Hospital
Kansas City, Missouri, 64111, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Northwell Health
Manhasset, New York, 11030, United States
Cornell
New York, New York, 10021, United States
NewYork-Presbyterian / Columbia University
New York, New York, 10032, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
OhioHealth Research Institute
Columbus, Ohio, 43214, United States
Oregon Health & Science Universtiy
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
Ascension Saint Thomas
Nashville, Tennessee, 37205, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chet Rihal
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2021
First Posted
June 9, 2021
Study Start
September 1, 2022
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2034
Last Updated
September 21, 2026
Record last verified: 2026-09