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Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System

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ClinicalTrials.gov Identifier: NCT03294200
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Tricuspid Regurgitation Device: TriCinch Coil System implantation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
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
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 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.




Primary Outcome Measures :
  1. All-cause mortality of the Per Protocol cohort at 30 days post procedure. [ Time Frame: 30 days post procedure ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Exercise tolerance (Six Minute Walk Test) [ Time Frame: 30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure ]
  6. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. ≥ 18 years old
  3. Subject has read and signed the informed consent prior to study related procedures.
  4. Willing and able to comply with all required follow-up evaluations and assessments.
  5. The 'Heart Team' assessment recommends TriCinch Coil Implantation
  6. New York Heart Associate Classification ≥ II.
  7. Left Ventricular Ejection Fraction ≥ 30%.
  8. 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
  9. Subject has suitable anatomy for investigational device implantation as per imaging requirements

Exclusion Criteria:

  1. Currently participating in another investigational drug or device study.
  2. Subject with Systolic pulmonary arterial pressure (sPAP) > 60mmHg as measured by Transthoracic Echocardiography (TTE)
  3. 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
  4. Moderate or Severe tricuspid valve stenosis (defined as a mean gradient ≥5 mmHg at normal heart rate)
  5. Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation more than moderate
  6. Intra-cardiac thrombus, mass or vegetation requiring active treatment.
  7. Implanted inferior vena cava (IVC) filter.
  8. Prior tricuspid repair or tricuspid replacement
  9. Known allergy to contrast media, silicone, PET, Co-Cr, stainless steel or nitinol that cannot be adequately pre-medicated
  10. History of cardiac transplantation
  11. Contraindication to Transthoracic/Transoesophageal Echocardiography (TTE/TOE).
  12. Endocarditis or severe infection within 12 months of scheduled implant procedure
  13. Myocardial Infarction (MI) or known unstable angina within the 30 days prior to the index procedure
  14. Cerebro Vascular Accident within the previous 6 months
  15. Hemodynamic instability or on IV inotropes
  16. Contraindication to anticoagulant therapy and antiplatelet therapy
  17. Documented history of bleeding diathesis, hypercoagulable or active peptic ulcer or gastrointestinal bleeding within 3 months of scheduled implant procedure
  18. Severe renal impairment or on dialysis
  19. Life expectancy less than 12 months.
  20. Acute anemia
  21. Chronic Oral Steroid Use ≥ 6 months
  22. Pregnant or lactating female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure
  23. Pulmonary embolism within the last 6 months
  24. Tricuspid Valve Tethering distance > 10 mm
  25. Presence of trans-tricuspid pacemaker or defibrillator leads which are determined as immobile or interfering with the procedure, as evaluated by echocardiography.
  26. Contra-indicated for blood transfusion or refuses transfusion
  27. Patient undergoing emergency treatment
  28. Patient without appropriate venous access

Information from the National Library of Medicine

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


Contacts
Contact: Julien Delumeau, MSc +33 7 85 10 59 70 julien.delumeau@4tech.ie

Locations
Australia, New South Wales
St Vincent's Hospital Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: David Muller, MD         
Australia, Queensland
Prince Charles Hospital Recruiting
Chermside, Queensland, Australia, 4032
Contact: Darren Walters, MD         
Australia, Victoria
Monash Heart Recruiting
Clayton, Victoria, Australia, 3168
Contact: Robert Gooley, MD         
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Lars Sondergaard, M         
Netherlands
St Antonius Hospital Recruiting
Nieuwegein, Netherlands
Contact: Martin Swaans, MD         
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
Contact: Nicolas Van Mieghem, MD         
Sponsors and Collaborators
4Tech Cardio Ltd.

Responsible Party: 4Tech Cardio Ltd.
ClinicalTrials.gov Identifier: NCT03294200     History of Changes
Other Study ID Numbers: CIP 2101-01
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
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

Additional relevant MeSH terms:
Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases