Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion

NCT06348394 | Recruiting FDA Device

• 1 other identifier: 023-318
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Left Atrial Appendage Closure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Periprocedural complications

  45 days after the procedure

• Procedural characteristics

  45 days after the procedure

• Patient satisfaction

  45 days after the procedure

• Periprocedural complications

  45 days after the procedure

• Periprocedural complications

  45 days after the procedure

Study Arms (2)

Intracardiac echocardiography Left atrial appendage closure.

ACTIVE COMPARATOR

Intra cardiac echocardiography will be performed prior to left atrial appendage closure.

Other: Intracardiac Echocardiography

Traditional transesophageal echocardiography guided Left atrial appendage closure

PLACEBO COMPARATOR

Transesophageal Echocardiography will be performed under general anesthesia.

Other: Intracardiac Echocardiography

Interventions

Intracardiac Echocardiography OTHER

Transesophageal echocardiography will be performed under general anesthesia.

Also known as: Transesophageal Echocardiography

Intracardiac echocardiography Left atrial appendage closure.; Traditional transesophageal echocardiography guided Left atrial appendage closure

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott and White Heart Hospital

Plano, Texas, 75093, United States

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 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.

  PMID: 27540038 BACKGROUND

Central Study Contacts

Bonnie Ostergren

CONTACT

4698144181; Bonnie.Ostergren@BSWHealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, parallel controlled, open-label, single center study

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: April 4, 2024
• Study Start: February 25, 2025
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 15, 2026

Record last verified: 2025-06

Locations

US (1)