The primary objective of the study is to generate feasibility safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from moderate to severe functional tricuspid regurgitation with annular dilatation. The TriCinch Coil System is a percutaneous catheter-based medical device for tricuspid valve repair.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Patients enrolled in this study with all eligibility criteria confirmed will be implanted with the TriCinch Coil System. This device offers a percutaneous treatment (access through the vein at the groin) to treat the leaking tricuspid valve.
Cedars Sinai Medical Center
Los Angeles, California, United States
HCA Research Institute at Los Robles Hospital & Medical Center
Thousand Oaks, California, United States
Piedmont Heart Hospital
Atlanta, Georgia, United States
All-cause mortality of the Per Protocol cohort at 30 days post procedure.
Time frame: 30 days post procedure
Number of individual adverse events related to the system or procedure.
Time frame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Echocardiographic changes in Effective Regurgitant Orifice Area (EROA) compared to Baseline
as assessed by the flow convergence method
Time frame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Functional changes as compared to Baseline for New York Heart Association (NYHA) classification
The severity of patients' heart failure symptoms is assessed using the New York Heart Association (NYHA) classification. Patients are ranked from Class I (no limitation of physical activity) to Class IV (unable to carry on any physical activity without discomfort).
Time frame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Rate of Heart Failure event post-procedure defined as a heart failure hospitalization or a heart failure hospitalization equivalent
Time frame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Exercise tolerance (Six Minute Walk Test)
Time frame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Quality of Life evaluation using the Kansas City Cardiomyopathy Questionnaire (KCCQ).
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
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Cardiovascular Institute of the South
Houma, Louisiana, United States
Abbott Northwestern - Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Columbia University Medical Center/NYPH
New York, New York, United States
Houston Methodist
Houston, Texas, United States
Baylor Plano Heart Hospital
Plano, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States
Time frame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure