Severe Tricuspid Valve RegurgitationCRITICALNCT05820516
Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation
An observational study of Severe Tricuspid Valve Regurgitation, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Tricuspid Valve Regurgitation
- What is being tested?
- TricValve implantation
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2025to May 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe, massive or torrential tricuspid regurgitation (TR) undergoing TricValve implantation from multiple Italian and European centers
Who may be able to join
- 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
Who cannot join
- 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
- Life expectancy less than one year
- Cerebro-vascular event within the past 3 months
Show all 13Show fewer
- 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)
- Documented primary coagulopathy or platelet disorder, including thrombocytopenia (absolute platelet count <90k)
- Documented evidence of significant renal dysfunction (serum creatinine > 3.0mg/dl) or on any form of dialysis at time of screening within the last 4 weeks
- Contraindication or known allergy to device's components, anti-coagulation therapy with vitamin K antagonists or contrast media that cannot be adequately pre-treated
- Evidence of an acute myocardial infarction (AMI) ≤ 1 month (30 days)
- Currently participating in another study of an investigational drug or device that would directly impact the treatment or outcome of the current study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, Pisa, 56124
Marco De Carlo, MD, +39050995326, marcodecarlo@gmail.com
Matteo Mazzola, MD, +39050994954, matteomazzolaj4@gmail.com
About this study
Official title: Cardiovascular, Renal and haemodynamIc Outcomes in Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation: an International Registry - CRITICAL INTERNATIONAL REGISTRY
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.
Read the detailed description
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):
- Clinical data regarding medical history, clinical status and medications;
- Biohumoral data (blood and urine chemistry);
- Haemodynamic data (Right Heart Catheterization);
- Echocardiographic data including Comprehensive 2D and Doppler Transtoracic Echocardiography and Transoesophageal Echocardiography;
- Anatomical data (Cardiac CT).
- At the time of procedure we will collect (see eCRF):
- Procedural data including the occurrence of peri-procedural complications;
- Haemodynamic data (Right Heart Catheterization).
- At discharge we will collect (see eCRF):
- Clinical data regarding clinical status and medications;
- Biohumoral data (blood and urine chemistry);
- Echocardiographic data including comprehensive 2D and Doppler Transtoracic Echocardiography;
- Peri-procedural data including the occurrence of peri-procedural complications.
- At 30-day follow-up we will collect (see eCRF):
- Clinical data regarding medical history, clinical status and medications;
- Biohumoral data (blood and urine chemistry);
- Echocardiographic data including comprehensive 2D and Doppler Transtoracic Echocardiography;
- At 6-month follow-up we will collect (see eCRF):
- Clinical data regarding medical history, clinical status and medications;
- Biohumoral data (blood and urine chemistry);
- Echocardiographic data including comprehensive 2D and Doppler transthoracic echocardiography;
- Haemodynamic data (Right Heart Catheterization), if clinically indicated.
- At 1-year follow-up we will collect (see eCRF):
- Clinical data regarding medical history, clinical status and medications;
- Biohumoral data (blood and urine chemistry);
- Echocardiographic data including Comprehensive 2D and Doppler Transtoracic Echocardiography;
- Haemodynamic data (Right Heart Catheterization), if clinically indicated.
- Conditions
- Severe Tricuspid Valve Regurgitation
- Being tested
- TricValve implantation
- Keywords
- Severe Tricuspid Valve Regurgitation, TricValve
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TricValve implantationDevice
TricValve implantation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6-month follow-up
Secondary outcomes (8)
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
Measured: 1-year follow-up
Cardiovascular mortality at 1-year follow-up
Cardiovascular mortality at 1-year follow-up
Measured: 1-year follow-up
Number of HF rehospitalizations at 1-year follow-up
Number of HF rehospitalizations at 1-year follow-up
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6- month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Tricuspid Valve RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona, Casa di Cura Pierangeli, Pescara, Fondazione Toscana Gabriele Monasterio, IRCCS San Raffaele, Humanitas Research Hospital IRCCS, Rozzano-Milan, Fondazione Poliambulanza Hospital (Brescia, Italy), IRCCS Casa Sollievo della Sofferenza, Ospedale Monaldi di Napoli, Ospedale San Bortolo di Vicenza, Azienda Ospedaliera San Camillo Forlanini, Azienda Policlinico Umberto I, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Asst Degli Spedali Civili Di Brescia, Ospedale Santa Corona di Pietra Ligure, Centro Cardiologico Monzino, Maria SS Addolorata di Eboli, Ospedale Polispecialistico Humanitas Gavazzeni, Bergamo, Niguarda Hospital, A.O. Ospedale Papa Giovanni XXIII, Azienda Ospedaliero-Universitaria Careggi, IRCCS Multimedica, Ospedale Miulli, Acquaviva delle Fonti, Azienda Ospedaliera "Sant'Andrea", I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, IRCCS ISMETT Palermo, I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Italy
- Responsible party
- Principal investigator, Marco De Carlo, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820516
- Sponsor's protocol ID
- CRITICAL
- Acronym
- CRITICAL
- Status last verified
- May 2026
- First submitted
- 28 Mar 2023
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular, Renal and haemodynamIc Outcomes in Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation: an International Registry - CRITICAL INTERNATIONAL REGISTRY
- ClinicalTrials.gov ID
- NCT05820516
- Acronym / sponsor ID
- CRITICAL / CRITICAL
- Conditions
- Severe Tricuspid Valve Regurgitation
- Keywords
- Severe Tricuspid Valve Regurgitation, TricValve
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona, Casa di Cura Pierangeli, Pescara, Fondazione Toscana Gabriele Monasterio, IRCCS San Raffaele, Humanitas Research Hospital IRCCS, Rozzano-Milan, Fondazione Poliambulanza Hospital (Brescia, Italy), IRCCS Casa Sollievo della Sofferenza, Ospedale Monaldi di Napoli, Ospedale San Bortolo di Vicenza, Azienda Ospedaliera San Camillo Forlanini, Azienda Policlinico Umberto I, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Asst Degli Spedali Civili Di Brescia, Ospedale Santa Corona di Pietra Ligure, Centro Cardiologico Monzino, Maria SS Addolorata di Eboli, Ospedale Polispecialistico Humanitas Gavazzeni, Bergamo, Niguarda Hospital, A.O. Ospedale Papa Giovanni XXIII, Azienda Ospedaliero-Universitaria Careggi, IRCCS Multimedica, Ospedale Miulli, Acquaviva delle Fonti, Azienda Ospedaliera "Sant'Andrea", I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, IRCCS ISMETT Palermo, I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Italy
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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):
- Clinical data regarding medical history, clinical status and medications;
- Biohumoral data (blood and urine chemistry);
- Haemodynamic data (Right Heart Catheterization);
- Echocardiographic data including Comprehensive 2D and Doppler Transtoracic Echocardiography and Transoesophageal Echocardiography;
- Anatomical data (Cardiac CT).
- At the time of procedure we will collect (see eCRF):
- Procedural data including the occurrence of peri-procedural complications;
- Haemodynamic data (Right Heart Catheterization).
- At discharge we will collect (see eCRF):
- Clinical data regarding clinical status and medications;
- Biohumoral data (blood and urine chemistry);
- Echocardiographic data including comprehensive 2D and Doppler Transtoracic Echocardiography;
- Peri-procedural data including the occurrence of peri-procedural complications.
- At 30-day follow-up we will collect (see eCRF):
- Clinical data regarding medical history, clinical status and medications;
- Biohumoral data (blood and urine chemistry);
- Echocardiographic data including comprehensive 2D and Doppler Transtoracic Echocardiography;
- At 6-month follow-up we will collect (see eCRF):
- Clinical data regarding medical history, clinical status and medications;
- Biohumoral data (blood and urine chemistry);
- Echocardiographic data including comprehensive 2D and Doppler transthoracic echocardiography;
- Haemodynamic data (Right Heart Catheterization), if clinically indicated.
- At 1-year follow-up we will collect (see eCRF):
- Clinical data regarding medical history, clinical status and medications;
- Biohumoral data (blood and urine chemistry);
- Echocardiographic data including Comprehensive 2D and Doppler Transtoracic Echocardiography;
- Haemodynamic data (Right Heart Catheterization), if clinically indicated.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe, massive or torrential tricuspid regurgitation (TR) undergoing TricValve implantation from multiple Italian and European centers
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
- Life expectancy less than one year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TricValve implantationTricValve implantation | Device | – |
Primary outcome
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 6-month follow-up
8 secondary outcomes
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
Time frame: 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.
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.
Time frame: 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.
Time frame: 6- month follow-up.
Change in 6MWD and in peak oxygen uptake (VO2) at 6-month follow-up.
Time frame: 6- month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Tricuspid Valve Regurgitation, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco De Carlo, MD (+39050995326, marcodecarlo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The composite of all-cause mortality and HF rehospitalization at 6-month follow-up (time frame: 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.