Study to evaluate the safety and performance of the INNOVALVE system
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
INNOVALVE system
Cedars-Sinai
Los Angeles, California, United States
RECRUITINGAbsence of implant or delivery related serious adverse events at 30 Days
Absence of implant or delivery related serious adverse events
Time frame: 30 days
Technical success
Time frame: Procedure
Procedural success
Time frame: 30 days
NYHA functional class
Time frame: 30 days, 6, 12 months and annually up to 5 years
Six-minute walk test
Time frame: 30 days, 6, 12 months and annually up to 5 years
Quality of life improvement (KCCQ-12)
Time frame: 30 days, 6, 12 months and annually up to 5 years
Reduction in MR grade
Time frame: 30 days, 6, 12 months and annually up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Naples Comprehensive Health
Naples, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
RECRUITINGNorthwestern
Chicago, Illinois, United States
RECRUITINGUniversity of Michigan Hospital and Health Systems
Ann Arbor, Michigan, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGMorristown Medical Center
Morristown, New Jersey, United States
RECRUITINGNorthwell Health
Manhasset, New York, United States
RECRUITINGCornell
New York, New York, United States
WITHDRAWNNewYork-Presbyterian / Columbia University
New York, New York, United States
RECRUITING...and 7 more locations