3D Transthoracic Echocardiographic Evaluation on Tricuspid Regurgitation Progression and Clinical Outcomes in Patients With Cardiac Implantable Electronic Device (3DECHO-TR)
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
As the use of cardiac implantable electronic devices(CIED) increases, CIED-related tricuspid regurgitation (CIED-related TR) is emerging as a critical clinical issue. CIED-related TR is one of the most common causes of primary TR, with a reported incidence ranging from approximately 10% to 30%. Numerous studies have confirmed that the severity of CIED-related TR is closely associated with poor prognosis.
This condition is particularly noteworthy because, unlike secondary TR, it possesses mechanical causes that are potentially intervenable. However, most studies published to date have reported results based on 2D echocardiography, which often leads to ambiguity in identifying the exact mechanisms behind the exacerbation of tricuspid regurgitation. Furthermore, there is a significant lack of data regarding TR associated with more recently introduced procedures, such as left bundle branch area pacing (LBBaP) and leadless pacemakers. Therefore, this study aims to perform 3D transthoracic echocardiography on patients with lead-based CIEDs and leadless pacemakers to comparatively analyze LBBaP and leadless pacemaker patients against conventional pacemaker patients in terms of TR exacerbation. By combining retrospective and prospective clinical data, this research will analyze the incidence and clinical impact of these conditions.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Juwon Kim
- Phone Number: 82+ 2-3410-3419
- Email: abcd186a@naver.com
Study Locations
-
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Seoul
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Seoul, Seoul, South Korea, 06351
- Recruiting
- Samsung Medical Center
-
Contact:
- Juwon Kim
- Phone Number: 82+ 2-3410-3419
- Email: abcd186a@naver.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
|
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 Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
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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
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.
|
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
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.
|
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
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.
|
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.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMC 2026-01-010
- KCT0011605 (Other Identifier: Korea National Institute of Health)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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