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3D Transthoracic Echocardiographic Evaluation on Tricuspid Regurgitation Progression and Clinical Outcomes in Patients With Cardiac Implantable Electronic Device

ConditionsTricuspid RegurgitationCIED ImplantationLeadless PacemakerPacemaker
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorSamsung Medical Center

About this trial

The goal of this observational study is to learn about the development and worsening of tricuspid regurgitation (TR) in patients who have cardiac implantable electronic devices (CIEDs).

The main objective is to compare left bundle branch area pacing (LBBaP) and leadless pacemakers against conventional pacemakers in terms of TR exacerbation.

Participants with these devices will have their retrospective and prospective clinical data analyzed and will undergo 3D transthoracic echocardiography to identify the exact mechanical causes of TR.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 19 years or older.

Patients who underwent the implantation procedure on or after January 2022.

Voluntary informed consent provided by the patient or their legal representative for the review of medical records and study-related data throughout the entire study period.

Disqualifiers

Patients with lead-based CIEDs whose leads do not cross the tricuspid annulus or those with two or more leads crossing the annulus.

Patients whose baseline degree of tricuspid regurgitation (TR) cannot be assessed due to the absence of transthoracic echocardiography (TTE) performed within three months of the procedure.

Patients with a history of ventricular lead extraction.

Patients who have undergone tricuspid valve replacement surgery.

Trial population

Subjects aged 19 years or older who underwent de novo implantation of a leadless PPM or a cardiac implantable electronic device (PPM or ICD) with trans-tricuspid leads at Samsung Medical Center between 2022 and 2025, and are at least one year post-implantation

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 3D Transthoracic echocardiographic evaluation

    Diagnostic test

    The incidence and mechanisms of worsening tricuspid regurgitation are identified through three-dimensional echocardiography, and the resulting structural and functional changes in the heart are evaluated.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: A patient one year after receiving a cardiac implantable electronic device1 intervention

Trial outcomes

Primary outcomes

1

hospitalization due to heart failure

Time frame
From the date of CIED implantation until the date of the first heart failure hospitalization or the date of the study 3D transthoracic echocardiography, whichever occurred first, assessed up to 6 years.

Secondary outcomes

1

incidence of CIED related, associated TR

Time frame
Assessed at the time of the study 3D transthoracic echocardiography, performed at least 1 year after CIED implantation, up to 6 years after implantation.
2

re-admission due to any cause

Time frame
From the date of CIED implantation until the date of the first event or the date of the study 3D transthoracic echocardiography, whichever occurred first, assessed up to 6 years.
3

Tricuspid valve intervention

Time frame
From the date of CIED implantation until the date of the first event or the date of the study 3D transthoracic echocardiography, whichever occurred first, assessed up to 6 years.
4

transvenous lead extraction or reposition

Time frame
From the date of CIED implantation until the date of the first event or the date of the study 3D transthoracic echocardiography, whichever occurred first, assessed up to 6 years.

Other outcomes

Sponsors and contacts

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

Samsung Medical Center

Lead sponsor

Source ClinicalTrials.gov
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