An observational study in Tricuspid Regurgitation, CIED Implantation and Leadless Pacemaker, sponsored by Samsung Medical Center. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Samsung Medical Center · Observational
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Among 15 studies in Tricuspid Valve Insufficiency with a site in Korea, Republic of — 6 open to participants now, 7 under way, 1 of them phase 3. Tricuspid Valve Insufficiency · Korea, Republic of.
Among the 15 studies in Tricuspid Valve Insufficiency with a site in Korea, Republic of, this one is one of 3 that started in 2026, is one of 6 observational ones, and was the 15th registered.
227 studies on the registry are indexed under Tricuspid Valve Insufficiency; 110 are open to participants now.
Browse Tricuspid Valve Insufficiency studies →6 of the 15 studies in Tricuspid Valve Insufficiency with a site in Korea, Republic of are open now. Recruiting first, the newest first:
Samsung Medical Center · Sites in Korea, Republic of
Tau-MEDICAL Co., Ltd. · Sites in Korea, Republic of
Ages 18+
Yonsei University · Sites in Korea, Republic of
Ages 19+
Daejeon St. Mary's hospital · Sites in Korea, Republic of
Ages 19+
Konkuk University Medical Center · Sites in Korea, Republic of
Ages 19–65
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 82 Tricuspid Valve Insufficiency studies recruiting now, 68 (83%) set no upper age limit and none (0%) stop at 75 or younger; 7 take children under 18; 2 take healthy volunteers.
This study: 19 Years and older · all sexes · no healthy volunteers.
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15 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,000 is above the median of 200 across 94 observational studies indexed under Tricuspid Valve Insufficiency.
Median enrollment 70 across the 9 interventional studies, 566 across the 6 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
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3 of 15 have an industry lead sponsor. The 7 most frequent:
Samsung Medical Center is the lead sponsor of 1,011 studies on the registry; 152 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Samsung Medical Center has 3 studies filed under Tricuspid Valve Insufficiency — fewer than ten, so there is no comparison to draw.
2 of the studies in Tricuspid Valve Insufficiency with a site in Korea, Republic of that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06027307Phase 3Asan Medical CenterEnavogliflozin Outcome Trial in Functional Tricuspid Regurgitation | 2027-06 |
| NCT07607093Samsung Medical CenterEfficacy of Early Rhythm Control in AF With TR Patients | 2027-02-28 |
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Among the 15 studies in Tricuspid Valve Insufficiency with a site in Korea, Republic of, from their registry updates:
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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.
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.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A. Permanent Pacemaker (PPM) B. Implantable Cardioverter-Defibrillator (ICD) C. Leadless Pacemaker
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Diagnostic Test: 3D Transthoracic echocardiographic evaluation
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.
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.
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.
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.
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.
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.
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Jan 2028, 24 months after the start.
Of 46 observational studies under Tricuspid Valve Insufficiency, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 106. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
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Tricuspid Valve Insufficiency →