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

July 30, 2020 updated by: 4Tech Cardio Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
All-cause mortality of the Per Protocol cohort at 30 days post procedure.
Time Frame: 30 days post procedure
30 days post procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
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
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
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
30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
4Tech Cardio Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 14, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 14, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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