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ChAracterization of Patients and Treatment OUtcomes in Severe Tricuspid Regurgitation

ConditionsTricuspid RegurgitationHeart FailureValve Heart Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of Warsaw

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

tricuspid regurgitation

qualification for transcatheter tricuspid valve intervention

Disqualifiers

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

Trial population

Patients with tricuspid regurgitation undergoing qualification process for transcatheter tricuspid valve intervention.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Transcatheter edge-to-edge repair

    Device

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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Medical therapy0 interventions
Group B: Transcatheter edge to edge repair of the tricuspid valve1 intervention

Trial outcomes

Primary outcomes

1

Mortality

Time to death of any cause

Time frame
24 months
2

HF hospitalization

Time to hospitalization due to heart failure

Time frame
24 months

Secondary outcomes

1

TR grade

Tricuspid regurgitation grade by echocardiographic assessment

Time frame
24 months
2

Aerobic capacity

Aerobic capacity assessed by 6-minute walk test

Time frame
24 months
3

QoL

Quality of life assessed by a quality of life survey

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Warsaw

Lead sponsor

Poznan University of Medical Sciences

Collaborator

Medical University of Gdansk

Collaborator

National Institute of Cardiology, Warsaw, Poland

Collaborator

Medical University of Silesia

Collaborator

Jagiellonian University

Collaborator

Source ClinicalTrials.gov
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