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.
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
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
Patients with severe, massive or torrential tricuspid regurgitation (TR) undergoing TricValve implantation from multiple Italian and European centers
Cohort
Other
TricValve implantation
DeviceTricValve implantation
The composite of all-cause mortality and HF rehospitalization at 6-month follow-up
The composite of all-cause mortality and HF rehospitalization at 6-month follow-up
The composite of all-cause mortality and HF rehospitalization at 1-year follow-up
The composite of all-cause mortality and HF rehospitalization at 1-year follow-up
Cardiovascular mortality at 1-year follow-up
Cardiovascular mortality at 1-year follow-up
Number of HF rehospitalizations at 1-year follow-up
Number of HF rehospitalizations at 1-year follow-up
Number of unscheduled cardiology consultations resulting in changes in medical therapy at 6- month follow-up.
Number of unscheduled cardiology consultations resulting in changes in medical therapy at 6- month follow-up.
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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
