Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03294200 |
Recruitment Status :
Terminated
(As per sponsor)
First Posted : September 26, 2017
Last Update Posted : July 31, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tricuspid Regurgitation | Device: TriCinch Coil System implantation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System |
Actual Study Start Date : | August 28, 2017 |
Actual Primary Completion Date : | July 14, 2020 |
Actual Study Completion Date : | July 14, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Tricinch Coil System treatment |
Device: TriCinch Coil System implantation
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, without the need for surgical intervention. |
- 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 compared to Baseline by means of echocardiographic semi-quantitative and quantitative measures [ 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 [ 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 (Kansas City Cardiomyopathy Questionnaire). [ Time Frame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294200
Australia, New South Wales | |
St Vincent's Hospital | |
Darlinghurst, New South Wales, Australia, 2010 | |
Australia, Queensland | |
Prince Charles Hospital | |
Chermside, Queensland, Australia, 4032 | |
Australia, Victoria | |
Monash Heart | |
Clayton, Victoria, Australia, 3168 | |
Belgium | |
AZ Sint Jan Brugge-Oostende AV | |
Brugge, Belgium, 8000 | |
Denmark | |
Rigshospitalet | |
Copenhagen, Denmark | |
France | |
Clinique Pasteur | |
Toulouse, France, 31076 | |
Germany | |
CardioVascular Center Frankfurt | |
Frankfurt am Main, Germany, 60389 | |
Netherlands | |
St Antonius Hospital | |
Nieuwegein, Netherlands | |
Erasmus Medical Center | |
Rotterdam, Netherlands | |
United Kingdom | |
Brighton & Sussex University Hospitals - Sussex County Hospital | |
Brighton, United Kingdom, BN2 5BE | |
Leeds General Infirmary | |
Leeds, United Kingdom, LS1 3EX | |
Kings College Hospital | |
London, United Kingdom, SE5 9RS | |
John Radcliffe Hospital | |
Oxford, United Kingdom, OX9 3DU |
Responsible Party: | 4Tech Cardio Ltd. |
ClinicalTrials.gov Identifier: | NCT03294200 |
Other Study ID Numbers: |
CIP 2101-01 |
First Posted: | September 26, 2017 Key Record Dates |
Last Update Posted: | July 31, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Tricuspid Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases |