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
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|
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 (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Percutaneous treatment of TR by TriCinch
Percutaneous treatment of Tricuspid Regurgitation with TriCinch System
Device: TriCinch System
Percutaneous treatment of Tricuspid Regurgitation
- 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.
- 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.
- 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.
- 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).
- 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).
- 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.
- 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.
- Quality of Life assessment [ Time Frame: 6 months ]Compare to baseline at 6 months
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
|Paris, Paris Cedex 18, France, 75877|
|Hospices Civils de Lyon|
|Toulouse, France, 31076|
|Bonn, Germany, 53127|
|CardioVasculares Centrum Frankfurt|
|Frankfurt am Main, Germany, 60389|
|UKE Heart Center|
|Milan, Lombardy, Italy, 20121|
|University Hospital Pisa|
|Pisa, Tuscany, Italy, 56124|
|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|
|St. Antonius Ziekenhuis|
|Nieuwegein, Netherlands, 3430EM|
|Principal Investigator:||Antonio Colombo, MD||San Raffaele Hospital|