3D Transthoracic Echocardiographic Evaluation on Tricuspid Regurgitation Progression and Clinical Outcomes in Patients With Cardiac Implantable Electronic Device
3DECHO-TR
2 other identifiers
observational
1,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2026
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 22, 2026
CompletedFirst Submitted
Initial submission to the registry
August 17, 2026
CompletedFirst Posted
Study publicly available on registry
August 31, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2028
August 31, 2026
January 1, 2026
2 years
August 17, 2026
August 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
hospitalization due to heart failure
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 (4)
incidence of CIED related, associated TR
Assessed at the time of the study 3D transthoracic echocardiography, performed at least 1 year after CIED implantation, up to 6 years after implantation.
re-admission due to any cause
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.
Tricuspid valve intervention
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.
transvenous lead extraction or reposition
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.
Study Arms (1)
A patient one year after receiving a cardiac implantable electronic device
Subjects aged 19 years or older who underwent de novo implantation of a leadless PPM or a cardiac implantable electronic device (PPM or ICD) at Samsung Medical Center between 2022 and 2025, and are at least one year post-implantation
Interventions
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.
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, Seoul, 06351, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assitant Professor
Study Record Dates
First Submitted
August 17, 2026
First Posted
August 31, 2026
Study Start
January 22, 2026
Primary Completion (Estimated)
January 31, 2028
Study Completion (Estimated)
January 31, 2028
Last Updated
August 31, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share