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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Percutaneous treatment of Tricuspid Regurgitation
Bichat Hospital
Paris, Paris Cedex 18, France
Hospices Civils de Lyon
Lyon, France
Clinique Pasteur
Toulouse, France
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.
Time frame: Up to 30 days
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.
Time frame: intraoperative
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.
Time frame: Time of discharge - 5 days
Safety: The percentage of participants with Major Adverse Events up to 3 months of the procedure.
Rate of device-related major adverse event (MAE).
Time frame: 3 months
Safety: The percentage of participants with Major Adverse Events within 6 months of the procedure.
Rate of device-related Major Adverse Event (MAE).
Time frame: 6 months
Performance: Assessment in the degree of Tricuspid Regurgitation at 3 months compared to baseline.
Ability to maintain Tricuspid Regurgitation with respect to baseline.
Time frame: 3 months
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Universitatsklinikum Bonn
Bonn, Germany
CardioVasculares Centrum Frankfurt
Frankfurt am Main, Germany
UKE Heart Center
Hamburg, Germany
Monzino Hospital
Milan, Lombardy, Italy
University Hospital Pisa
Pisa, Tuscany, Italy
Ferrarotto Hospital
Catania, Italy
Fondazione Toscana G. Monasterio Ospedale del Cuore G. Pasquinucci
Massa, Italy
...and 4 more locations
Performance: Assessment in the degree of Tricuspid Regurgitation at 6 months compared to baseline.
Ability to maintain Tricuspid Regurgitation with respect to baseline.
Time frame: 6 months