Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation

NCT05820516 | Recruiting

• 1 other identifier: CRITICAL
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Tricuspid Valve Regurgitation

Keywords

Severe Tricuspid Valve Regurgitation; TricValve

Outcome Measures

Primary Outcomes (1)

• 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

  6-month follow-up

Secondary Outcomes (8)

• The composite of all-cause mortality and HF rehospitalization at 1-year follow-up

  1-year follow-up

• Cardiovascular mortality at 1-year follow-up

  1-year follow-up

• Number of HF rehospitalizations at 1-year follow-up

  1-year follow-up

• Number of unscheduled cardiology consultations resulting in changes in medical therapy at 6- month follow-up.

  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.

  6- month follow-up

Interventions

TricValve implantation DEVICE

TricValve implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe, massive or torrential tricuspid regurgitation (TR) undergoing TricValve implantation from multiple Italian and European centers

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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
• Patients unsuitable for implantation because of thrombosis of the lower venous system or vena cava filter
• Evidence of an acute myocardial infarction (AMI) ≤ 1 month (30 days)
• Liver cirrhosis Child C
• Female patient of child-bearing potential

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Pisana

Pisa, 56124, Italy

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Marco De Carlo, MD

CONTACT

+39050995326; marcodecarlo@gmail.com

Matteo Mazzola, MD

CONTACT

+39050994954; matteomazzolaj4@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 19, 2023
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

IT (1)