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

Stopped early · Not applicable

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

In brief

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.

Key facts

Study ID

NCT03632967

Run by

4Tech Cardio Ltd.

People needed

7

Starts

2018-09-12

Expected to finish

2020-07-14

Last updated by the study team

2020-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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