Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation (NCT05820516) | Clinical Trial Compass
RecruitingNot Applicable
Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation
Italy100 participantsStarted 2025-02-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. Distance covered in 6-minute walk test (6MWT) ≥ 60m
✓. Patient/authorized legal guardian understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent Patient/patient's authorized legal guardian is geographically stable (or willing to return for required study follow-up) and understands and is willing to fulfil all of the expected requirements of the clinical protocol
Exclusion criteria
✕. 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
What they're measuring
1
The composite of all-cause mortality and HF rehospitalization at 6-month follow-up
✕. Systolic pulmonary arterial pressure \> 65 mmHg as assessed by Doppler echocardiography
✕. Life expectancy less than one year
✕. Cerebro-vascular event within the past 3 months
✕. History of mitral/tricuspid endocarditis within the last 12 months
✕. Patient has untreated significant left sided valvular heart disease which requires treatment (e.g. mitral regurgitation or stenosis, and aortic regurgitation or stenosis)