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

Primary Purpose

Tricuspid Regurgitation

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
TriCinch System
Sponsored by
4Tech Cardio Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tricuspid Regurgitation focused on measuring tricuspid, regurgitation, repair, outcomes

Eligibility Criteria

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

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.

Sites / Locations

  • Bichat Hospital
  • Hospices Civils de Lyon
  • Clinique Pasteur
  • Universitatsklinikum Bonn
  • CardioVasculares Centrum Frankfurt
  • UKE Heart Center
  • Monzino Hospital
  • University Hospital Pisa
  • Ferrarotto Hospital
  • Fondazione Toscana G. Monasterio Ospedale del Cuore G. Pasquinucci
  • San Raffaele Hospital
  • Azienda Ospedaliera di Padova
  • Fondazione PTV Policlinico Tor Vergata
  • St. Antonius Ziekenhuis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Percutaneous treatment of TR by TriCinch

Arm Description

Percutaneous treatment of Tricuspid Regurgitation with TriCinch System

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 13, 2014
Last Updated
March 13, 2018
Sponsor
4Tech Cardio Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02098200
Brief Title
Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™
Acronym
PREVENT
Official Title
Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Regurgitation
Keywords
tricuspid, regurgitation, repair, outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous treatment of TR by TriCinch
Arm Type
Experimental
Arm Description
Percutaneous treatment of Tricuspid Regurgitation with TriCinch System
Intervention Type
Device
Intervention Name(s)
TriCinch System
Intervention Description
Percutaneous treatment of Tricuspid Regurgitation
Primary Outcome Measure Information:
Title
Safety: The percentage of participants with Major Adverse Events within 30 days of the procedure.
Description
Freedom from major adverse event: death, Q-wave myocardial infarction, cardiac tamponade, cardiac surgery for failed TriCinch implantation, stroke, or septicaemia.
Time Frame
Up to 30 days
Title
Performance: The reduction in degree of tricuspid regurgitation measured immediately after the procedure compared to baseline.
Description
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 Frame
intraoperative
Title
Performance: The reduction in the degree of tricuspid regurgitation measured at time of discharge compared to baseline.
Description
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 Frame
Time of discharge - 5 days
Secondary Outcome Measure Information:
Title
Safety: The percentage of participants with Major Adverse Events up to 3 months of the procedure.
Description
Rate of device-related major adverse event (MAE).
Time Frame
3 months
Title
Safety: The percentage of participants with Major Adverse Events within 6 months of the procedure.
Description
Rate of device-related Major Adverse Event (MAE).
Time Frame
6 months
Title
Performance: Assessment in the degree of Tricuspid Regurgitation at 3 months compared to baseline.
Description
Ability to maintain Tricuspid Regurgitation with respect to baseline.
Time Frame
3 months
Title
Performance: Assessment in the degree of Tricuspid Regurgitation at 6 months compared to baseline.
Description
Ability to maintain Tricuspid Regurgitation with respect to baseline.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Quality of Life assessment
Description
Compare to baseline at 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Colombo, MD
Organizational Affiliation
San Raffaele Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bichat Hospital
City
Paris
State/Province
Paris Cedex 18
ZIP/Postal Code
75877
Country
France
Facility Name
Hospices Civils de Lyon
City
Lyon
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
Universitatsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
CardioVasculares Centrum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60389
Country
Germany
Facility Name
UKE Heart Center
City
Hamburg
Country
Germany
Facility Name
Monzino Hospital
City
Milan
State/Province
Lombardy
ZIP/Postal Code
20121
Country
Italy
Facility Name
University Hospital Pisa
City
Pisa
State/Province
Tuscany
ZIP/Postal Code
56124
Country
Italy
Facility Name
Ferrarotto Hospital
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Fondazione Toscana G. Monasterio Ospedale del Cuore G. Pasquinucci
City
Massa
ZIP/Postal Code
54100
Country
Italy
Facility Name
San Raffaele Hospital
City
Milano
ZIP/Postal Code
20129
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Fondazione PTV Policlinico Tor Vergata
City
Roma
Country
Italy
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3430EM
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™

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