Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System

Study Overview
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Brief Summary
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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.

Official Title
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Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System

Conditions
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Functional Tricuspid Regurgitation, Heart Valve Diseases, Tricuspid Valve Insufficiency

Intervention / Treatment
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* Device: Tricinch Coil System Implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe functional tricuspid regurgitation (TR) defined as: TR severity 2+ to 4+ (according to semi-quantitative echocardiographic color flow doppler evaluation); and Annular diameter ≥ 40 mm confirmed by echocardiography Major of age( ≥ 18 years old or older per local regulation) Subject has read and signed the informed consent prior to study related procedures. Willing and able to comply with all required follow-up evaluations and assessments. The 'Heart Team' assessment recommends TriCinch Coil Implantation New York Heart Associate Classification ≥ II. Left Ventricular Ejection Fraction ≥ 30%. Heart failure symptoms (such as fluid retention and severe oedema, liver stasis) despite on optimized medical therapy by the local heart team; at minimum subject on diuretic use Subject has suitable anatomy for investigational device implantation as per imaging requirements Exclusion Criteria: Currently participating in another investigational drug or device study. Subject with Systolic pulmonary arterial pressure (sPAP) > 60mmHg as measured by Transthoracic Echocardiography (TTE) Subject requiring another cardiac procedure in the framework of the index procedure; subject requiring a percutaneous procedure within 30 days before or after the procedure or a cardiac surgical procedure within 3 months before or after the procedure Moderate or Severe tricuspid valve stenosis (defined as a mean gradient ≥5 mmHg at normal heart rate) Aortic and/or pulmonic valve stenosis and/or regurgitation more than or equal to moderate Mitral stenosis and/or regurgitation more than moderate Intra-cardiac thrombus, mass or vegetation requiring active treatment. Implanted inferior vena cava (IVC) filter. Prior tricuspid repair or tricuspid replacement Known allergy to contrast media, silicone, PET, Co-Cr, stainless steel or nitinol that cannot be adequately pre-medicated History of cardiac transplantation Contraindication to Transthoracic/Transoesophageal Echocardiography (TTE/TOE). Endocarditis or severe infection within 12 months of scheduled implant procedure Myocardial Infarction (MI) or known unstable angina within the 30 days prior to the index procedure Cerebro Vascular Accident within the previous 6 months Hemodynamic instability or on IV inotropes Contraindication to anticoagulant therapy and antiplatelet therapy Bleeding disorders or hypercoagulable condition (at risk of blood clots Active peptic ulcer or active GI bleeding within 3 months of scheduled implant procedure Severe renal impairment or on dialysis Life expectancy less than 12 months. Acute anemia Chronic Oral Steroid Use ≥ 6 months Pregnant or lactating female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure Pulmonary embolism within the last 6 months Tricuspid Valve Tethering distance > 10 mm Presence of trans-tricuspid pacemaker or defibrillator leads which are determined as immobile or interfering with the procedure, as evaluated by echocardiography. Contra-indicated for blood transfusion or refuses transfusion Patient undergoing emergency treatment Patient without appropriate venous access

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device: TriCinch Coil System treatment<br> | Device: Tricinch Coil System Implantation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality of the Per Protocol cohort at 30 days post procedure. |  | 30 days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of individual adverse events related to the system or procedure. |  | 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 | 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). | 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 |  | 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure | 
| Exercise tolerance (Six Minute Walk Test) |  | 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. | 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure |