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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Juwon Kim
- 電話番号：82+ 2-3410-3419
- メール：abcd186a@naver.com
研究場所
-
-
Seoul
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Seoul、Seoul、韓国、06351
- 募集
- Samsung Medical Center
-
コンタクト：
- Juwon Kim
- 電話番号：82+ 2-3410-3419
- メール：abcd186a@naver.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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hospitalization due to heart failure
時間枠：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.
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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.
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
incidence of CIED related, associated TR
時間枠：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.
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re-admission due to any cause
時間枠：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.
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Tricuspid valve intervention
時間枠：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.
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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.
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transvenous lead extraction or reposition
時間枠：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.
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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.
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- SMC 2026-01-010
- KCT0011605 (その他の識別子：Korea National Institute of Health)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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