An observational study in Severe Tricuspid Valve Regurgitation, sponsored by Azienda Ospedaliero, Universitaria Pisana. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Azienda Ospedaliero, Universitaria Pisana · Observational
International Registry to collect patients with severe TR undergoing TricValve implantation from multiple Italian and European centers, aimed at:
Study Design
Type of study: Non-profit, multi-center, observational, prospective cohort study (with retrospective inclusion of the first cases performed)
Patient population: 100 patients
Date of beginning of enrollment: April 1st, 2023 (plus inclusion of patients treated since 2022)
Duration of the study: 12 months
All patients enrolled will undergo serial evaluations (Figure 1).
At Baseline we will collect (see eCRF):
At the time of procedure we will collect (see eCRF):
At discharge we will collect (see eCRF):
At 30-day follow-up we will collect (see eCRF):
At 6-month follow-up we will collect (see eCRF):
At 1-year follow-up we will collect (see eCRF):
226 studies on the registry are indexed under Tricuspid Valve Insufficiency; 109 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 94 observational studies indexed under Tricuspid Valve Insufficiency.
Browse Tricuspid Valve Insufficiency studies →Azienda Ospedaliero, Universitaria Pisana is the lead sponsor of 57 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with severe, massive or torrential tricuspid regurgitation (TR) undergoing TricValve implantation from multiple Italian and European centers
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TricValve 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
Time frame: 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
Time frame: 1-year follow-up
Cardiovascular mortality at 1-year follow-up
Cardiovascular mortality at 1-year follow-up
Time frame: 1-year follow-up
Number of HF rehospitalizations at 1-year follow-up
Number of HF rehospitalizations at 1-year follow-up
Time frame: 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.
Time frame: 6- month follow-up
Change in New York Hearts Association (NYHA) functional class and change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 6-month and 1-year follow-up.
Change in New York Hearts Association (NYHA) functional class and change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 6-month and 1-year follow-up.
Time frame: 6- month follow-up
Change in the dose of loop diuretics (in mg/day) at 6-month follow-up
Change in the dose of loop diuretics (in mg/day) at 6-month follow-up
Time frame: 6- month follow-up.
Progression of kidney disease, defined as the composite of end-stage kidney disease, a decrease in eGFR to <10 ml/min/1.73 m2, a decrease in eGFR ≥40% from baseline, and death from renal causes at 6-month follow-up.
Progression of kidney disease, defined as the composite of end-stage kidney disease, a decrease in eGFR to \<10 ml/min/1.73 m2, a decrease in eGFR ≥40% from baseline, and death from renal causes at 6-month follow-up.
Time frame: 6- month follow-up.
Change in 6MWD and in peak oxygen uptake (VO2) at 6-month follow-up.
Change in 6MWD and in peak oxygen uptake (VO2) at 6-month follow-up.
Time frame: 6- month follow-up.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Azienda Ospedaliero, Universitaria Pisana