Clinical Trial

Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation

Study acronym: CRITICAL
Recruiting
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Summary
International Registry to collect patients with severe TR undergoing TricValve implantation from multiple Italian and European centers, aimed at: * Assessing the effect of TricValve implantation on cardiovascular and all-cause mortality, HF rehospitalization, renal function, functional capacity and quality of life. * Clarifying the haemodynamic effects of TricValve implantation and investigating their pathophysiological implications.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-04-07; most recent amendment 2026-05-06.
Status change: Not Yet Recruiting → Recruiting 2025-01-27
Trial Details
NCT Number NCT05820516
Lead Sponsor Azienda Ospedaliero, Universitaria Pisana
Collaborators: Azienda Ospedaliera Universitaria Integrata Verona, Casa di Cura Pierangeli, Pescara, Fondazione Toscana Gabriele Monasterio, IRCCS San Raffaele, Humanitas Research Hospital IRCCS, Rozzano-Milan, Fondazione Poliambulanza Hospital (Brescia, Italy), IRCCS Casa Sollievo della Sofferenza, Ospedale Monaldi di Napoli, Ospedale San Bortolo di Vicenza, Azienda Ospedaliera San Camillo Forlanini, Azienda Policlinico Umberto I, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Asst Degli Spedali Civili Di Brescia, Ospedale Santa Corona di Pietra Ligure, Centro Cardiologico Monzino, Maria SS Addolorata di Eboli, Ospedale Polispecialistico Humanitas Gavazzeni, Bergamo, Niguarda Hospital, A.O. Ospedale Papa Giovanni XXIII, Azienda Ospedaliero-Universitaria Careggi, IRCCS Multimedica, Ospedale Miulli, Acquaviva delle Fonti, Azienda Ospedaliera "Sant'Andrea", I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, IRCCS ISMETT Palermo, I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Italy
Conditions Severe Tricuspid Valve Regurgitation
Enrollment 100 participants
Start Date 2025-02-01
Primary Completion 2026-12 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-05-11