Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation

NCT05820516 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

  • Severe Tricuspid Valve Regurgitation

Interventions

DEVICE

TricValve implantation

TricValve implantation

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona

    collaborator OTHER
  • Casa di Cura Pierangeli, Pescara

    collaborator UNKNOWN
  • Fondazione Toscana Gabriele Monasterio

    collaborator OTHER
  • IRCCS San Raffaele

    collaborator OTHER
  • Humanitas Research Hospital IRCCS, Rozzano-Milan

    collaborator OTHER
  • Fondazione Poliambulanza Hospital (Brescia, Italy)

    collaborator UNKNOWN
  • Casa Sollievo della Sofferenza-IRCCS, San Giovanni Rotondo

    collaborator UNKNOWN
  • Ospedale Monaldi di Napoli

    collaborator UNKNOWN
  • Ospedale San Bortolo di Vicenza

    collaborator OTHER
  • Azienda Ospedaliera San Camillo Forlanini

    collaborator OTHER
  • Azienda Policlinico Umberto I

    collaborator OTHER
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    collaborator OTHER
  • Asst Degli Spedali Civili Di Brescia

    collaborator OTHER
  • Ospedale Santa Corona di Pietra Ligure

    collaborator UNKNOWN
  • Centro Cardiologico Monzino

    collaborator OTHER
  • Maria SS Addolorata di Eboli

    collaborator UNKNOWN
  • Ospedale Polispecialistico Humanitas Gavazzeni, Bergamo

    collaborator UNKNOWN
  • Niguarda Hospital

    collaborator OTHER
  • A.O. Ospedale Papa Giovanni XXIII

    collaborator OTHER
  • Azienda Ospedaliero-Universitaria Careggi

    collaborator OTHER
  • IRCCS Multimedica

    collaborator OTHER
  • Ospedale Miulli, Acquaviva delle Fonti

    collaborator UNKNOWN
  • Azienda Ospedaliera "Sant'Andrea"

    collaborator OTHER
  • I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

    collaborator OTHER
  • IRCCS ISMETT Palermo

    collaborator UNKNOWN
  • I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Italy

    collaborator UNKNOWN
  • Azienda Ospedaliero, Universitaria Pisana

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2026-12-31
Completion
2027-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05820516 on ClinicalTrials.gov