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

Recruitingn/aAges 19 Years - anyAllSamsung Medical Center
NCT07793916 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aged 19 years or older. * Patients who are at least one year post-implantation of one of the following Cardiac Implantable Electronic Devices (CIEDs): A. Permanent Pacemaker (PPM) B. Implantable Cardioverter-Defibrillator (ICD) C. Leadless Pacemaker * 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. Exclusion Criteria: * 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. * Individuals who refuse active medical treatment.
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What it tests

  • 3D Transthoracic echocardiographic evaluation
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Where

1 site
Samsung Medical Center
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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