Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion

Обзор

This single-center, prospective, randomized study will evaluate the safety and feasibility of Intracardiac echocardiography (ICE)-guided Left atrial appendage closure (LAAC) when compared to the traditional Transesophageal echocardiography (TEE) approach.

Подробное описание

The primary objective of this study is to assess the efficacy and safety of using Intracardiac echocardiography (ICE) to guide implantation of percutaneous left atrial appendage closure (LAAC) devices.

Primary endpoints include procedural success following implantation of the left atrial appendage occlusion (LAAO) device. Procedural success specifies that the device should be implanted in the correct position without device related complications and no peri-device leaks \>5 mm on color doppler.

Secondary end points include periprocedural complications (such as pericardial effusion/tamponade, stroke, death, vascular complications, and device embolization), procedural characteristics (total duration, fluoroscopy time, contrast volume, Length of hospital stay), cost of hospitalization, in-hospital patient satisfaction, and clinical alterations at 45-day follow-up.

Вмешательства

• Другое Intracardiac Echocardiography
  Transesophageal echocardiography will be performed under general anesthesia.

Первичные конечные точки

• Procedural success following implantation of the left atrial appendage occlusion (LAAO) device. [Срок оценки: Intra op]

Вторичные конечные точки (8)

• Periprocedural complications [Срок оценки: 45 days after the procedure]
• Procedural characteristics [Срок оценки: 45 days after the procedure]
• Patient satisfaction [Срок оценки: 45 days after the procedure]
• Periprocedural complications [Срок оценки: 45 days after the procedure]
• Periprocedural complications [Срок оценки: 45 days after the procedure]
• Procedural characteristics [Срок оценки: 45 days after the procedure]
• Procedural characteristics [Срок оценки: 45 days after the procedure]
• Procedural characteristics [Срок оценки: 45 days after the procedure]

Критерии участия

Критерии включения

• Patients diagnosed for non-valvular atrial fibrillation with documented paroxysmal, persistent, or permanent NVAF.
• Deemed to be at high risk of stroke or systemic embolism (SE) defined as a CHADS2 score ≥2 or a CHA2DS2-VASc score ≥3.
• Patient suitable for OAC with warfarin or DOAC and have appropriate rationale to seek a nonpharmacologic alternative to long-term OAC, meeting commercial LAAO criteria indications.
• Can undergo appropriate pre-procedural imaging with Computed tomography (CT) or transesophageal echocardiography (TEE).
• Patient should be able to comply with the protocol.
• Provide written informed consent before study participation.
• Ages 18 and above

Критерии исключения

1\) A patient will be ineligible for inclusion in this study if he or she meets any of the following criteria:

• Presence of an intracardiac thrombus on the preprocedural TEE or CT.
• History of previously implanted device for atrial septal defect or patent foramen ovale.
• Severe LV dysfunction (LVEF < 40%) or greater than moderate valvular heart disease.
• Enrollment in another study that competes or interferes with this study. Approval to dual enroll must be approved by the other study.
• Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests.
• Subject with planned cardiac intervention between the time of consenting and up to 60 days post-LAAO.
• Any other condition or co-morbidity which, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he or she is enrolled in the study.
• For women of childbearing potential: Pregnant or breastfeeding women or planning pregnancy during the course of the investigation are excluded due to the risks involved in the procedure
• Children below 18 years, prisoners and patients who are unable to provide consent are excluded.

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

Другое

Центры проведения

США · 1 центр

• Baylor Scott and White Heart Hospital — Plano

Публикации

• Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192. PMID 25399274
• Hemam ME, Kuroki K, Schurmann PA, Dave AS, Rodriguez DA, Saenz LC, Reddy VY, Valderrabano M. Left atrial appendage closure with the Watchman device using intracardiac vs transesophageal echocardiography: Procedural and cost considerations. Heart Rhythm. 2019 Mar;16(3):334-342. doi: 10.1016/j.hrthm.2018.12.013. PMID 30827462
• Tzikas A, Holmes DR Jr, Gafoor S, Ruiz CE, Blomstrom-Lundqvist C, Diener HC, Cappato R, Kar S, Lee RJ, Byrne RA, Ibrahim R, Lakkireddy D, Soliman OI, Nabauer M, Schneider S, Brachmann J, Saver JL, Tiemann K, Sievert H, Camm AJ, Lewalter T. Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies. Eu PMID 27540038
• Al-Azizi K, Thomas S, Hajar MBA, Pickering T, McCullough K, Dorton C, Moubarak G, Ma TW, Banwait J, Hale S, Gupta S, DiMaio JM, Szerlip M, Matar R, Aqtash O, Baig I, Trehan S, Potluri S. Intracardiac versus transesophageal echocardiographic guidance for left atrial appendage occlusion: Design and rationale of the ICE-TEE trial. Cardiovasc Revasc Med. 2026 Mar;84:82-87. doi: 10.1016/j.carrev.2025.0 PMID 40579293

Идентификаторы

NCT: NCT06348394 · 023-318

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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