Accuracy of LAA Occluder Size Selection: CT vs. DSA During Combined AF Ablation and LAA Occlusion

Официальное название

The Accuracy of Left Atrial Appendage Occluder Size Selection Between Preoperative CT and Intraoperative DSA Evaluation During a Combined Atrial Fibrillation Ablation and Left Atrial Appendage Occlusion Procedure

Обзор

This study is a prospective, multi-center, randomized controlled trial. The subjects are patients scheduled to undergo a combined procedure of atrial fibrillation (AF) ablation and left atrial appendage (LAA) occlusion. After signing the informed consent form, the subjects will be randomly assigned to either the cardiac Computed Tomography (CT) group or the Digital Subtraction Angiography (DSA) group. The operator will select the appropriate LAA occluder size for implantation based on different measurement methods. All subjects will undergo clinical follow-up before discharge and at 3 months postoperatively, as well as telephone follow-up 1-5 years after the surgery.

Вмешательства

• Другое CT group
  After completing the AF ablation, select the appropriate LAA occluder based on preoperative CT measurements for implantation.
• Другое DSA group
  After completing the AF ablation, select the appropriate LAA occluder based on intraoperative DSA measurements for implantation.

Первичные конечные точки

• Accuracy of LAA occluder size selection [Срок оценки: During procedure]

Вторичные конечные точки (4)

• Procedure success [Срок оценки: During procedure]
• Peri-device leak at 3 months post-procedure [Срок оценки: 3 months]
• Procedure-related times [Срок оценки: During procedure]
• Incidence of major adverse events (MAE) related to the device or procedure within 3 months post-procedure [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Age ≥ 18 years;
• Patients with non-valvular atrial fibrillation scheduled to undergo atrial fibrillation ablation and percutaneous left atrial appendage occlusion;
• Able to understand the purpose of the trial, willing to participate in the study, and the subject or their legal representative has signed the informed consent form, and is willing to complete the follow-up according to the protocol requirements.

Критерии исключения

• Allergy to contrast agents or other conditions that preclude cardiac CT or DSA imaging;
• Absence of clear images for measuring the diameter of the LAA in all layers of the CT scan;
• Imaging indicates the presence of thrombus in the left atrium or LAA;
• Patients with valvular AF (mechanical valve replacement or moderate to severe mitral stenosis combined with AF);
• LAA depth < 15 mm, or LAA anchor zone diameter < 10 mm or > 33 mm;
• Female patients of childbearing age planning to become pregnant during the follow-up period required by this study;
• Currently participating in another clinical trial of drugs or medical devices and has not yet completed the primary endpoints of that study, which may confound the results of this study or affect the participant's compliance with the follow-up;
• Other conditions that the investigator deems make the participant unsuitable for this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 5 центров

• Foshan Nanhai District People's Hospital — Foshan
• The Second People's Hospital of Foshan — Foshan
• Meizhou Hospital of Traditional Chinese Medicine — Meizhou
• First Affiliated Hospital of Shantou University Medical College — Shantou
• Guangdong Provincial Zhongshan Hospital of Traditional Chinese Medicine — Zhongshan

Идентификаторы

NCT: NCT06455644 · B-2024-091

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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