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

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.

Study Overview

• Status: Terminated
• Conditions: Tricuspid Regurgitation
• Intervention / Treatment: Device: TriCinch Coil System implantation

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincent's Hospital
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • Prince Charles Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Heart
• Belgium
  • Brugge, Belgium, 8000
    • AZ Sint Jan Brugge-Oostende av
• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet
• France
  • Toulouse, France, 31076
    • Clinique Pasteur
• Germany
  • Frankfurt am Main, Germany, 60389
    • Cardiovascular center Frankfurt
• Netherlands
  • Nieuwegein, Netherlands
    • St Antonius Hospital
  • Rotterdam, Netherlands
    • Erasmus Medical Center
• United Kingdom
  • Brighton, United Kingdom, BN2 5BE
    • Brighton & Sussex University Hospitals - Sussex County Hospital
  • Leeds, United Kingdom, LS1 3EX
    • Leeds General Infirmary
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital
  • Oxford, United Kingdom, OX9 3DU
    • John Radcliffe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality of the Per Protocol cohort at 30 days post procedure.	30 days post procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: 4Tech Cardio Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 28, 2017
• Primary Completion (ACTUAL): July 14, 2020
• Study Completion (ACTUAL): July 14, 2020

Study Registration Dates

• First Submitted: September 22, 2017
• First Submitted That Met QC Criteria: September 22, 2017
• First Posted (ACTUAL): September 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: CIP 2101-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No