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

Primary Purpose

Tricuspid Regurgitation

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
TriCinch Coil System implantation
Sponsored by
4Tech Cardio Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tricuspid Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St Vincent's Hospital
  • Prince Charles Hospital
  • Monash Heart
  • AZ Sint Jan Brugge-Oostende AV
  • Rigshospitalet
  • Clinique Pasteur
  • CardioVascular Center Frankfurt
  • St Antonius Hospital
  • Erasmus Medical Center
  • Brighton & Sussex University Hospitals - Sussex County Hospital
  • Leeds General Infirmary
  • Kings College Hospital
  • John Radcliffe Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tricinch Coil System treatment

Arm Description

Outcomes

Primary Outcome Measures

All-cause mortality of the Per Protocol cohort at 30 days post procedure.

Secondary Outcome Measures

Number of individual adverse events related to the system or procedure.
Echocardiographic changes compared to Baseline by means of echocardiographic semi-quantitative and quantitative measures
Functional changes as compared to Baseline for New York Heart Association (NYHA) classification
Rate of Heart Failure event post-procedure defined as a heart failure hospitalization or a heart failure hospitalization equivalent
Exercise tolerance (Six Minute Walk Test)
Quality of Life evaluation (Kansas City Cardiomyopathy Questionnaire).

Full Information

First Posted
September 22, 2017
Last Updated
July 30, 2020
Sponsor
4Tech Cardio Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03294200
Brief Title
Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
Official Title
Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
As per sponsor
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
July 14, 2020 (Actual)
Study Completion Date
July 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
4Tech Cardio Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tricinch Coil System treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
TriCinch Coil System implantation
Intervention Description
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 Measure Information:
Title
All-cause mortality of the Per Protocol cohort at 30 days post procedure.
Time Frame
30 days post procedure
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
Exercise tolerance (Six Minute Walk Test)
Time Frame
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
St Vincent's Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Monash Heart
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
AZ Sint Jan Brugge-Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
CardioVascular Center Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60389
Country
Germany
Facility Name
St Antonius Hospital
City
Nieuwegein
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Facility Name
Brighton & Sussex University Hospitals - Sussex County Hospital
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX9 3DU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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