A Phase 1 interventional study of TriCinch System in Tricuspid Regurgitation, sponsored by 4Tech Cardio Ltd.. Completed at 14 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-14.
Sponsored by 4Tech Cardio Ltd. · Phase 1, Interventional, and Treatment
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.
Exclusion Criteria:
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.
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
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
Quality of Life assessment
Compare to baseline at 6 months
Time frame: 6 months
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tricuspid Valve Insufficiency→
4Tech Cardio Ltd.