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
85
INNOVALVE system
Cedars-Sinai
Los Angeles, California, United States
Serious adverse events (SAE) through 30 days post-procedure
Serious adverse events (SAE) through 30 days post-procedure
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.
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RECRUITING...and 11 more locations