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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Juwon Kim
- Numero di telefono: 82+ 2-3410-3419
- Email: abcd186a@naver.com
Luoghi di studio
-
-
Seoul
-
Seoul, Seoul, Corea del Sud, 06351
- Reclutamento
- Samsung Medical Center
-
Contatto:
- Juwon Kim
- Numero di telefono: 82+ 2-3410-3419
- Email: abcd186a@naver.com
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
hospitalization due to heart failure
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
incidence of CIED related, associated TR
Lasso di tempo: Assessed at the time of the study 3D transthoracic echocardiography, performed at least 1 year after CIED implantation, up to 6 years after implantation.
|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SMC 2026-01-010
- KCT0011605 (Altro identificatore: Korea National Institute of Health)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .