Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation

NCT ID: NCT05820516

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2026-05-31

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

TricValve implantation

TricValve implantation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. The subject must be 18 years of age or older

2. 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

3. Suitable for TricValve Transcatheter Bicaval Valves System implantation according to anatomic criteria by computed tomography (CT)

4. The subjects must have severe, tricuspid regurgitation leading to New York Heart Association (NYHA) class III or IV

5. Distance covered in 6-minute walk test (6MWT) ≥ 60m

6. 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

1. Known significant intracardiac shunt (e.g. ventricular septal defect) or congenital structural heart disease based on heart team decision

2. 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

3. Right ventricular failure (TAPSE ≤13 mm)

4. Systolic pulmonary arterial pressure > 65 mmHg as assessed by Doppler echocardiography

5. Life expectancy less than one year

6. Cerebro-vascular event within the past 3 months

7. History of mitral/tricuspid endocarditis within the last 12 months

8. Patient has untreated significant left sided valvular heart disease which requires treatment (e.g. mitral regurgitation or stenosis, and aortic regurgitation or stenosis)

9. Documented primary coagulopathy or platelet disorder, including thrombocytopenia (absolute platelet count <90k)

10. 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

11. Contraindication or known allergy to device's components, anti-coagulation therapy with vitamin K antagonists or contrast media that cannot be adequately pre-treated

12. Patients unsuitable for implantation because of thrombosis of the lower venous system or vena cava filter

13. Evidence of an acute myocardial infarction (AMI) ≤ 1 month (30 days)

14. Liver cirrhosis Child C

15. Female patient of child-bearing potential

16. Currently participating in another study of an investigational drug or device that would directly impact the treatment or outcome of the current study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role: lead

Responsible Party

Marco De Carlo

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Marco De Carlo, MD

Role: CONTACT

marcodecarlo@gmail.com

+39050995326

Matteo Mazzola, MD

Role: CONTACT

matteomazzolaj4@gmail.com

+39050994954

Facility Contacts

Marco De Carlo, MD

Role: primary

marcodecarlo@gmail.com

+39050995326

Matteo Mazzola, MD

Role: backup

matteomazzolaj4@gmail.com

+39050994954

Other Identifiers

CRITICAL

Identifier Type: -

Identifier Source: org_study_id