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

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ClinicalTrials.gov Identifier: NCT02098200
Recruitment Status : Completed
First Posted : March 27, 2014
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
4Tech Cardio Ltd.

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.


Condition or disease Intervention/treatment Phase
Tricuspid Regurgitation Device: TriCinch System Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™
Study Start Date : June 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : October 2017

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. 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.


Other Outcome Measures:
  1. Quality of Life assessment [ Time Frame: 6 months ]
    Compare to baseline at 6 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098200


Locations
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France
Bichat Hospital
Paris, Paris Cedex 18, France, 75877
Hospices Civils de Lyon
Lyon, France
Clinique Pasteur
Toulouse, France, 31076
Germany
Universitatsklinikum Bonn
Bonn, Germany, 53127
CardioVasculares Centrum Frankfurt
Frankfurt am Main, Germany, 60389
UKE Heart Center
Hamburg, Germany
Italy
Monzino Hospital
Milan, Lombardy, Italy, 20121
University Hospital Pisa
Pisa, Tuscany, Italy, 56124
Ferrarotto Hospital
Catania, Italy, 95124
Fondazione Toscana G. Monasterio Ospedale del Cuore G. Pasquinucci
Massa, Italy, 54100
San Raffaele Hospital
Milano, Italy, 20129
Azienda Ospedaliera di Padova
Padova, Italy, 35128
Fondazione PTV Policlinico Tor Vergata
Roma, Italy
Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3430EM
Sponsors and Collaborators
4Tech Cardio Ltd.
Investigators
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Principal Investigator: Antonio Colombo, MD San Raffaele Hospital

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Responsible Party: 4Tech Cardio Ltd.
ClinicalTrials.gov Identifier: NCT02098200     History of Changes
Other Study ID Numbers: PREVENT_001/2013
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

Keywords provided by 4Tech Cardio Ltd.:
tricuspid
regurgitation
repair
outcomes

Additional relevant MeSH terms:
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Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases