Outcome of Patients with Severe Functional TR According to Medical, Transcatheter or Surgical Treatment
Launched by OTTAWA HEART INSTITUTE RESEARCH CORPORATION · Apr 11, 2023
Trial Information
Current as of November 11, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
TRIGISTRY is an international, observational study looking at people with severe functional tricuspid regurgitation (TR) — a leak in the tricuspid valve of the heart that is not due to a congenital problem. The study compares three real-world paths people take: continuing with standard medical care (no valve procedure), isolated tricuspid valve surgery, or a less invasive transcatheter valve intervention. It uses the TRI-SCORE risk tool to help compare outcomes fairly between groups. This is not a randomized trial; researchers will look back at the care people actually received at many centers around the world. Enrollment started in 2022 and is by invitation, with an estimated 3,500 participants, and results are planned to focus on survival at 2 years and longer-term outcomes up to 10 years.
Who can be eligible? Adults aged 18 and older with isolated functional TR that is moderate-to-severe or severe, and no significant disease of the left-side heart valves (such as the mitral valve). Exclusions include congenital valve problems, prior tricuspid valve procedures, organic TR, or other major valve diseases. If you participate, your treatment will be decided by you and your doctors as part of usual care, and the study will gather information from medical records to compare how people do across the three groups. This study is observational, not testing a new drug or device, and it involves centers in the United States, Europe, and other countries.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age ≥ 18 years
- • Isolated (no left-valvular heart disease (mitral regurgitation) \>2)
- • AND Functional
- • AND Moderate to severe or severe Tricuspid regurgitation
- Exclusion Criteria:
- • Congenital valvular disease,
- • Previous tricuspid valve intervention,
- • Organic tricuspid valvular disease
- • Associated valvular heart disease
About Ottawa Heart Institute Research Corporation
The Ottawa Heart Institute Research Corporation is a leading clinical research organization dedicated to advancing cardiovascular medicine through innovative research and clinical trials. Affiliated with the renowned University of Ottawa Heart Institute, the corporation focuses on conducting high-quality, ethically-driven studies that aim to improve patient outcomes and enhance understanding of heart-related diseases. With a commitment to collaboration and excellence, the organization engages multidisciplinary teams of researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective therapies and interventions for cardiovascular health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Rochester, Minnesota, United States
Leiden, Netherlands
Ottawa, Ontario, Canada
Leiden, Netherlands
Madrid, Spain
Madrid, Spain
Madrid, Spain
Madrid, Spain
Köln, Germany
Nantes, France
Madrid, Spain
Tel Aviv, Israel
Madrid, Spain
Lille, France
Rouen, France
Frankfurt, Germany
Rennes, France
Créteil, France
Berlin, Germany
New York, New York, United States
Bad Oeynhausen, Germany
Amiens, France
Leipzig, Germany
Milan, Italy
Lugano, Switzerland
New York, New York, United States
Vienna, Austria
Québec, Canada
Toronto, Canada
Vancouver, Canada
Lyon, France
Marseille, France
Nancy, France
Paris, France
Saint Denis, France
Toulouse, France
Bonn, Germany
Hamburg, Germany
Hamburg, Germany
Hamburg, Germany
Mainz, Germany
Munich, Germany
Milan, Italy
Bern, Switzerland
Zürich, Switzerland
New York, New York, United States
Patients applied
Trial Officials
David Messika-Zeitoun
Principal Investigator
Ottawa Heart Institute Research Corporation
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported