Actively Recruiting
Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation
Led by Azienda Ospedaliero, Universitaria Pisana · Updated on 2026-05-11
100
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
Sponsors
A
Azienda Ospedaliero, Universitaria Pisana
Lead Sponsor
A
Azienda Ospedaliera Universitaria Integrata Verona
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Massive or torrential symptomatic tricuspid regurgitation confirmed by echocardiography with significant backflow in the inferior or superior vena cava and a v-wave 25 25 25 mmHg measured by right heart catheterization within 8 weeks prior to implantation
- Suitable for TricValve transcatheter bicaval valve system implantation based on anatomical criteria from computed tomography
- Severe tricuspid regurgitation causing New York Heart Association (NYHA) class III or IV symptoms
- Ability to walk at least 60 meters in a 6-minute walk test
- Patient or legal guardian understands the procedure, agrees to follow-up evaluations, provides written informed consent, and is geographically stable or willing to return for follow-up
You will not qualify if you...
- Presence of significant intracardiac shunt or congenital structural heart disease as determined by heart team
- Need for other elective cardiac procedures such as PCI or CABG within 30 days before or 90 days after the procedure
- Right ventricular failure with TAPSE 13 mm
- Systolic pulmonary arterial pressure greater than 65 mmHg by Doppler echocardiography
- Life expectancy less than one year
- Cerebrovascular event within the past 3 months
- History of mitral or tricuspid endocarditis within the last 12 months
- Untreated significant left-sided valvular heart disease requiring treatment
- Known primary coagulopathy or platelet disorder including platelet count less than 90,000
- Significant renal dysfunction with serum creatinine over 3.0 mg/dl or dialysis within the last 4 weeks
- Allergy or contraindication to device components, vitamin K antagonist anticoagulation, or contrast media not manageable with pre-treatment
- Acute myocardial infarction within the past 30 days
- Current participation in another investigational drug or device study affecting this treatment or outcome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Azienda Ospedaliero Universitaria Pisana
Pisa, Pisa, Italy, 56124
Actively Recruiting
Research Team
M
Marco De Carlo, MD
CONTACT
M
Matteo Mazzola, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here