Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
Not Applicable
Terminated
- Conditions
- Tricuspid Regurgitation
- Interventions
- Device: TriCinch Coil System implantation
- Registration Number
- NCT03294200
- Lead Sponsor
- 4Tech Cardio Ltd.
- Brief Summary
The objective of the study is to generate safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from significant functional tricuspid regurgitation with annular dilatation.
The TriCinch Coil System is a percutaneous catheter-based medical device for tricuspid valve repair.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 18
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
- ≥ 18 years old
- 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, mitral and/or pulmonic valve stenosis and/or regurgitation more than or equal to moderate
- Mitral valve 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tricinch Coil System treatment TriCinch Coil System implantation -
- Primary Outcome Measures
Name Time Method All-cause mortality of the Per Protocol cohort at 30 days post procedure. 30 days post procedure
- Secondary Outcome Measures
Name Time Method 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 compared to Baseline by means of echocardiographic semi-quantitative and quantitative measures 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 (Kansas City Cardiomyopathy Questionnaire). 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
Trial Locations
- Locations (13)
St Vincent's Hospital
🇦🇺Darlinghurst, New South Wales, Australia
Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
Clinique Pasteur
🇫🇷Toulouse, France
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
Brighton & Sussex University Hospitals - Sussex County Hospital
🇬🇧Brighton, United Kingdom
CardioVascular Center Frankfurt
🇩🇪Frankfurt am Main, Germany
Kings College Hospital
🇬🇧London, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
AZ Sint Jan Brugge-Oostende AV
🇧🇪Brugge, Belgium
Rigshospitalet
🇩🇰Copenhagen, Denmark
St Antonius Hospital
🇳🇱Nieuwegein, Netherlands
Monash Heart
🇦🇺Clayton, Victoria, Australia
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands