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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intracardiac echocardiography Left atrial appendage closure. | Active Comparator | Intra cardiac echocardiography will be performed prior to left atrial appendage closure. |
|
| Traditional transesophageal echocardiography guided Left atrial appendage closure | Placebo Comparator | Transesophageal Echocardiography will be performed under general anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracardiac Echocardiography | Other | Transesophageal echocardiography will be performed under general anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 measured as: Peri-device leaks greater than 5 milliliters on color doppler (Yes/No) | Intra op |
| Measure | Description | Time Frame |
|---|---|---|
| Periprocedural complications | Pericardial effusion/tamponade measured as (Yes/No) | 45 days after the procedure |
| Procedural characteristics | Total duration measured as number of minutes. |
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Inclusion Criteria:
Exclusion Criteria
1) A patient will be ineligible for inclusion in this study if he or she meets any of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bonnie Ostergren | Contact | 4698144181 | Bonnie.Ostergren@BSWHealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott and White Heart Hospital | Recruiting | Plano | Texas | 75093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25399274 | Background | 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. | |
| 30827462 |
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Prospective, randomized, parallel controlled, open-label, single center study
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| 45 days after the procedure |
| Patient satisfaction | Patient satisfaction will be assessed in-hospital by a questionnaire addressing anesthesia-related discomfort. | 45 days after the procedure |
| Periprocedural complications | Stroke measured as (Yes/No) | 45 days after the procedure |
| Periprocedural complications | Death measured as (Yes/No) | 45 days after the procedure |
| Procedural characteristics | Fluoroscopy time measured as number of minutes. | 45 days after the procedure |
| Procedural characteristics | Contrast volume measured in milli liters. | 45 days after the procedure |
| Procedural characteristics | Length of hospital stay measured as number of days. | 45 days after the procedure |
| 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. |
| 27540038 | Background | 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. Europace. 2017 Jan;19(1):4-15. doi: 10.1093/europace/euw141. Epub 2016 Aug 18. |
| 40579293 | Derived | 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.2025.05.029. Epub 2025 Jun 1. |