3D Echocardiography to See How CIEDs May Worsen Tricuspid Regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study analyzes both past and current patient data to understand how cardiac implantable devices influence tricuspid regurgitation. Researchers will use three-dimensional transthoracic echocardiography to identify the mechanical causes of TR in patients with CIEDs. The study compares left bundle branch area pacing and leadless pacemakers with conventional pacemakers regarding TR progression and its clinical impact. By integrating retrospective and prospective data, the project aims to clarify incidence and outcomes related to CIED-related TR. The work is conducted at Samsung Medical Center and focuses on patients implanted since 2022 or later.

Why it matters

Who can join: the full rules

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.

Where it's running

• Samsung Medical Center
  Seoul, Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Juwon Kim
• Email: abcd186a@naver.com
• Phone: 82+ 2-3410-3419

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.