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ChAracterization of Patients and Treatment OUtcomes in Severe Tricuspid Regurgitation

NCT06838611 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-02-20

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Transcatheter edge-to-edge repair

Transcatheter edge-to-edge repair of the tricuspid valve for the treatment of severe tricuspid valve regurgitation.

Sponsors & Collaborators

  • Poznan University of Medical Sciences

    collaborator OTHER

  • Medical University of Gdansk

    collaborator OTHER

  • National Institute of Cardiology, Warsaw, Poland

    collaborator OTHER

  • Medical University of Silesia

    collaborator OTHER

  • Jagiellonian University Collegium Medicum, Krakow, Poland

    collaborator UNKNOWN

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Adam Rdzanek, MD PhD · First Department of Cardiology, Medical University of Warsaw

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-14
Primary Completion
2027-11-14
Completion
2028-07-01
FDA Device
Yes

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06838611 on ClinicalTrials.gov