Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliero, Universitaria Pisana

About this trial

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.

Eligibility criteria

Qualifiers

The subject must be 18 years of age or older

The subject must be a patient with massive or torrential symptomatic tricuspid regurgitation demonstrated by echocardiography with significant backflow in the IVC and/or SVC and with a v-wave ≥ 25 mmHg as demonstrated by right heart catheterization (measured in the IVC and/or SVC 2-4 cm above/ below right atrium (RA) inflow) within 8 weeks prior to the implantation

Suitable for TricValve Transcatheter Bicaval Valves System implantation according to anatomic criteria by computed tomography (CT)inserire la parte retrospettiva ossia i pazienti che già hanno avuto l'impianto

The subjects must have severe, tricuspid regurgitation leading to New York Heart Association (NYHA) class III or IV

Disqualifiers

Known significant intracardiac shunt (e.g. ventricular septal defect) or congenital structural heart disease based on heart team decision

Requirement for other elective cardiac procedures e.g. Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG) up to 90 days after the procedure or 30 days before the procedure

Right ventricular failure (TAPSE ≤13 mm)

Systolic pulmonary arterial pressure > 65 mmHg as assessed by Doppler echocardiography

Trial design

Treatments tested in this trial

  • TricValve implantation

Treatment groups

No treatment groups listed

Sponsors and collaborators

Azienda Ospedaliero, Universitaria Pisana

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Collaborator

Casa di Cura Pierangeli, Pescara

Collaborator

Fondazione Toscana Gabriele Monasterio

Collaborator

IRCCS San Raffaele

Collaborator

Humanitas Research Hospital IRCCS, Rozzano-Milan

Collaborator

Fondazione Poliambulanza Hospital (Brescia, Italy)

Collaborator

Casa Sollievo della Sofferenza-IRCCS, San Giovanni Rotondo

Collaborator

Ospedale Monaldi di Napoli

Collaborator

Ospedale San Bortolo di Vicenza

Collaborator

Azienda Ospedaliera San Camillo Forlanini

Collaborator

Azienda Policlinico Umberto I

Collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborator

Asst Degli Spedali Civili Di Brescia

Collaborator

Ospedale Santa Corona di Pietra Ligure

Collaborator

Centro Cardiologico Monzino

Collaborator

Maria SS Addolorata di Eboli

Collaborator

Ospedale Polispecialistico Humanitas Gavazzeni, Bergamo

Collaborator

Niguarda Hospital

Collaborator

A.O. Ospedale Papa Giovanni XXIII

Collaborator

Azienda Ospedaliero-Universitaria Careggi

Collaborator

IRCCS Multimedica

Collaborator

Ospedale Miulli, Acquaviva delle Fonti

Collaborator

Azienda Ospedaliera "Sant'Andrea"

Collaborator

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Collaborator

IRCCS ISMETT Palermo

Collaborator

I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Italy

Collaborator