ChAracterization of Patients and Treatment OUtcomes in Severe Tricuspid Regurgitation
CAPTURE
1 other identifier
observational
300
1 country
1
Brief Summary
The goal of this observational study is to characterize the population of patients qualified for transcatheter tricuspid valve interventions (TTVI). It is expected to:
- Describe the profile of patients qualified for TTVI
- Establish the most common causes for disqualification from TTVI
- Evaluate the immediate and long-term efficacy of TTVI
- Evaluate TTVI safety Participants will undergo a standard qualification procedure for TTVI and then will be subject to a follow-up consisting of clinical examination, echocardiography and laboratory testing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 14, 2023
CompletedFirst Submitted
Initial submission to the registry
February 16, 2025
CompletedFirst Posted
Study publicly available on registry
February 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
February 20, 2025
February 1, 2025
4 years
February 16, 2025
February 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mortality
Time to death of any cause
24 months
HF hospitalization
Time to hospitalization due to heart failure
24 months
Secondary Outcomes (3)
TR grade
24 months
Aerobic capacity
24 months
QoL
24 months
Study Arms (2)
Medical therapy
Cohort of patients disqualified from transcatheter procedures and receiving medical therapy only.
Transcatheter edge to edge repair of the tricuspid valve
Patients undergoing transcatheter tricuspid valve edge-to-edge repair
Interventions
Transcatheter edge-to-edge repair of the tricuspid valve for the treatment of severe tricuspid valve regurgitation.
Eligibility Criteria
Patients with tricuspid regurgitation undergoing qualification process for transcatheter tricuspid valve intervention.
You may qualify if:
- tricuspid regurgitation
- qualification for transcatheter tricuspid valve intervention
You may not qualify if:
- tricuspid regurgitation qualified for surgical treatment
- concomitant left heart valve disease qualified for surgical treatment
- multivessel coronary artery disease qualified for coronary artery bypass grafting
- lack of patient's consent to enter the registry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of Warsawlead
- Poznan University of Medical Sciencescollaborator
- Medical University of Gdanskcollaborator
- National Institute of Cardiology, Warsaw, Polandcollaborator
- Medical University of Silesiacollaborator
- Jagiellonian Universitycollaborator
Study Sites (1)
First Department of Cardiology, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-091, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Rdzanek, MD PhD
First Department of Cardiology, Medical University of Warsaw
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Tomaniak Mariusz MD PhD Assoc. Prof.
Study Record Dates
First Submitted
February 16, 2025
First Posted
February 20, 2025
Study Start
November 14, 2023
Primary Completion (Estimated)
November 14, 2027
Study Completion (Estimated)
July 1, 2028
Last Updated
February 20, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share