Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™ (PREVENT)

March 13, 2018 updated by: 4Tech Cardio Ltd.

The TriCinch System™ is intended for percutaneous treatment of tricuspid regurgitation.

It is a percutaneous catheter-based device designed for tricuspid valve repair in order to decrease effective cross-sectional area and relieve symptoms in patients with tricuspid valve regurgitation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Implantation Procedure: Unlike the standard open chest, arrested heart approach, the 4TECH TriCinch System™ provides a percutaneous solution for tricuspid valve regurgitation treatment: this procedure is performed through deep sedation, while the heart is beating, without the need for respiratory assistance.

The TriCinch System™ consists of a Delivery System that enables transcatheter placement of an implant that can be adjusted to correct Tricuspid valve regurgitation. The TriCinch Delivery System is inserted from the femoral vein to access the right atrium of the heart. At the end of the correction process, the TriCinch Delivery System and the venous introducer are removed and the procedure is concluded.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

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

  • France
      • Lyon, France
        • Hospices Civils de Lyon
      • Toulouse, France, 31076
        • Clinique Pasteur
    • Paris Cedex 18
      • Paris, Paris Cedex 18, France, 75877
        • Bichat Hospital
  • Germany
      • Bonn, Germany, 53127
        • Universitätsklinikum Bonn
      • Frankfurt am Main, Germany, 60389
        • CardioVasculäres Centrum Frankfurt
      • Hamburg, Germany
        • UKE Heart Center
  • Italy
      • Catania, Italy, 95124
        • Ferrarotto Hospital
      • Massa, Italy, 54100
        • Fondazione Toscana G. Monasterio Ospedale del Cuore G. Pasquinucci
      • Milano, Italy, 20129
        • San Raffaele Hospital
      • Padova, Italy, 35128
        • Azienda Ospedaliera Di Padova
      • Roma, Italy
        • Fondazione PTV Policlinico Tor Vergata
    • Lombardy
      • Milan, Lombardy, Italy, 20121
        • Monzino Hospital
    • Tuscany
      • Pisa, Tuscany, Italy, 56124
        • University Hospital Pisa
  • Netherlands
      • Nieuwegein, Netherlands, 3430EM
        • St. Antonius Ziekenhuis

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

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Functional symptomatic tricuspid regurgitation (TR) 2+ to 4+ on a scale of 4+ (moderate to severe), with annular dilatation greater than 40mm.
  • Signed informed consent form prior to any study-related procedure.
  • Available and able to return to the study site for post-procedural follow-up examination
  • Eighteen (18) years of age or older.

Exclusion Criteria:

  • Requirement for concomitant cardiac procedure (other than atrial fibrillation correction surgery, closure of PFO (Patent Foramen Ovale) or ASD (Atrial Septal Defect), or PTCA (percutaneous treatment of coronary artery) or CAD (coronary artery bypass surgery) from 1 to 3 months after or before other procedure.
  • Presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year.
  • Cerebro-vascular event within the past 6 months.
  • History of mitral/tricuspid endocarditis within the last 12 months.
  • Organic tricuspid disease.
  • Contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated.
  • Severe hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg, measurement done by sphygmomanometer with stethoscope, allow the patient to sit for at least 5 minutes before beginning BP measurements).
  • Female patient is pregnant (urine HCG test result positive) or lactating.
  • Known alcohol or drug abuser.
  • Currently participating in the study of an investigational drug or device.
  • At heart team's judgement, patient IVC dimension is not adequate for device implantation.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Percutaneous treatment of TR by TriCinch
Percutaneous treatment of Tricuspid Regurgitation with TriCinch System
Device: TriCinch System
Percutaneous treatment of Tricuspid Regurgitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: The percentage of participants with Major Adverse Events within 30 days of the procedure.
Time Frame: Up to 30 days
Freedom from major adverse event: death, Q-wave myocardial infarction, cardiac tamponade, cardiac surgery for failed TriCinch implantation, stroke, or septicaemia.
Up to 30 days
Performance: The reduction in degree of tricuspid regurgitation measured immediately after the procedure compared to baseline.
Time Frame: intraoperative
Ability to reduce tricuspid regurgitation by at least 1 degree immediately following implantation of the TriCinch device assessed by means of quantitative echocardiographic parameters.
intraoperative
Performance: The reduction in the degree of tricuspid regurgitation measured at time of discharge compared to baseline.
Time Frame: Time of discharge - 5 days
Ability to reduce tricuspid regurgitation by at least 1 degree immediately following implantation of the TriCinch device assessed by means of quantitative echocardiographic parameters.
Time of discharge - 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: The percentage of participants with Major Adverse Events up to 3 months of the procedure.
Time Frame: 3 months
Rate of device-related major adverse event (MAE).
3 months
Safety: The percentage of participants with Major Adverse Events within 6 months of the procedure.
Time Frame: 6 months
Rate of device-related Major Adverse Event (MAE).
6 months
Performance: Assessment in the degree of Tricuspid Regurgitation at 3 months compared to baseline.
Time Frame: 3 months
Ability to maintain Tricuspid Regurgitation with respect to baseline.
3 months
Performance: Assessment in the degree of Tricuspid Regurgitation at 6 months compared to baseline.
Time Frame: 6 months
Ability to maintain Tricuspid Regurgitation with respect to baseline.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life assessment
Time Frame: 6 months
Compare to baseline at 6 months
6 months

Collaborators and Investigators

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

Sponsor

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

June 1, 2013

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

March 13, 2014

First Submitted That Met QC Criteria

March 25, 2014

First Posted (Estimate)

March 27, 2014

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 13, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREVENT_001/2013

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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