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

4Tech Cardio Ltd.9 sites in 1 country7 target enrollmentSeptember 12, 2018

ConditionsFunctional Tricuspid Regurgitation Heart Valve Diseases Tricuspid Valve Insufficiency

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Functional Tricuspid Regurgitation
Sponsor: 4Tech Cardio Ltd.
Enrollment: 7
Locations: 9
Primary Endpoint: All-cause mortality of the Per Protocol cohort at 30 days post procedure.
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 12, 2018

End Date

July 14, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

4Tech Cardio Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

All-cause mortality of the Per Protocol cohort at 30 days post procedure.

Time Frame: 30 days post procedure

Secondary Outcomes

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(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(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).(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)