The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).
A prospective, single-arm, open-label, multi-center early feasibility clinical study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Replacement of the tricusupid valve using Trisol System in a transcatheter approach
Cedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGPiedmont Heart Institute
Atlanta, Georgia, United States
RECRUITINGColumbia University Medical Center/NYPH
New York, New York, United States
Rate of device-related serious adverse events
Rate of device-related serious adverse events, including death (cardiovascular and non- cardiovascular), MI (MVARC definitions), disabling stroke, life-threatening bleeding (MVARC type III-V), renal failure requiring dialysis, emergency surgery, need for additional surgical procedures due to device failure
Time frame: Up to 30 days
Rate of technical success
Technical success: delivery and deployment of the device in the correct position and retrieval of the delivery system.
Time frame: During procedure
Rate of procedural success
Procedural success: freedom from emergency surgery or reintervention related to the device or access procedure, without death, stroke, or device dysfunction
Time frame: Up to 30 days
Change in TR from baseline
Change in TR from baseline: reduction in TR grade immediately following implantation as compared to baseline TR grade, based on TEE imaging.
Time frame: During procedure
Clinical performance endpoints - Change in TR from baseline
Change in TR from baseline: reduction in TR grade as compared to baseline TR grade, based on TTE imaging
Time frame: At 30 days, 6 months, 12 months
Clinical performance endpoints - Change in NYHA class
New York Heart Association (NYHA) functional class: change in NYHA from baseline
Time frame: At 30 days, 6 months, 12 months, and then annually
Clinical performance endpoints --minute walk test
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Cleveland Clinic
Cleveland, Ohio, United States
RECRUITINGMain Line Health / Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States
NOT_YET_RECRUITINGVanderbilt University Medical Center
Nashville, Tennessee, United States
RECRUITINGUniversity of Virginia Cardiology
Charlottesville, Virginia, United States
RECRUITINGSix-minute walk test: change in distance (m) from baseline
Time frame: At 30 days, 6 months and 12 months
Quality-of-Life: change from baseline as measured by Kansas City Cardiomyopathy Questionnaire
Clinical performance endpoints -Quality-of-Life: change from baseline as measured by Kansas City Cardiomyopathy Questionnaire
Time frame: At 30 days, 6 months and 12 months