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RecruitingNCT06348394ICETEEUpdated Sep 3, 2026

Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion

An interventional study of Intracardiac Echocardiography and Traditional transesophageal echocardiography in Left Atrial Appendage Closure, sponsored by Baylor Research Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Baylor Research Institute · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
444
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Left Atrial Appendage Closure
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients diagnosed for non-valvular atrial fibrillation with documented paroxysmal, persistent, or permanent NVAF.
  2. Deemed to be at high risk of stroke or systemic embolism (SE) defined as a CHADS2 score ≥2 or a CHA2DS2-VASc score ≥3.
  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.
  4. Can undergo appropriate pre-procedural imaging with Computed tomography (CT) or transesophageal echocardiography (TEE).
  5. Patient should be able to comply with the protocol.
  6. Provide written informed consent before study participation.
  7. Ages 18 and above

Exclusion criteria

Exclusion Criteria

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

  1. Presence of an intracardiac thrombus on the preprocedural TEE or CT.
  2. History of previously implanted device for atrial septal defect or patent foramen ovale.
  3. Severe LV dysfunction (LVEF \< 40%) or greater than moderate valvular heart disease.
  4. Enrollment in another study that competes or interferes with this study. Approval to dual enroll must be approved by the other study.
  5. Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests.
  6. Subject with planned cardiac intervention between the time of consenting and up to 60 days post-LAAO.
  7. 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.
  8. 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
  9. Children below 18 years, prisoners and patients who are unable to provide consent are excluded.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
444 participants (estimated)

Study arms

  • Active comparator
    Intracardiac echocardiography Left atrial appendage closure.

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

    Device: Intracardiac Echocardiography

  • Placebo comparator
    Traditional transesophageal echocardiography guided Left atrial appendage closure

    Transesophageal Echocardiography will be performed under general anesthesia.

    Device: Traditional transesophageal echocardiography

Interventions

  • DeviceIntracardiac Echocardiography

    Transesophageal echocardiography will be performed under general anesthesia.

  • DeviceTraditional transesophageal echocardiography

    Traditional transesophageal echocardiography guided Left atrial appendage closure

05

What researchers measure

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)

    Time frame: Intra op

Secondary outcomes

  1. Periprocedural complications

    Pericardial effusion/tamponade measured as (Yes/No)

    Time frame: 45 days after the procedure

  2. Procedural characteristics

    Total duration measured as number of minutes.

    Time frame: 45 days after the procedure

  3. Patient satisfaction

    Patient satisfaction will be assessed in-hospital by a questionnaire addressing anesthesia-related discomfort.

    Time frame: 45 days after the procedure

  4. Periprocedural complications

    Stroke measured as (Yes/No)

    Time frame: 45 days after the procedure

  5. Periprocedural complications

    Death measured as (Yes/No)

    Time frame: 45 days after the procedure

  6. Procedural characteristics

    Fluoroscopy time measured as number of minutes.

    Time frame: 45 days after the procedure

  7. Procedural characteristics

    Contrast volume measured in milli liters.

    Time frame: 45 days after the procedure

  8. Procedural characteristics

    Length of hospital stay measured as number of days.

    Time frame: 45 days after the procedure

06

Study locations

1 of 1 sites recruiting
07

References and documents

Publications

  • 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. PubMed 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. PubMed 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. Europace. 2017 Jan;19(1):4-15. doi: 10.1093/europace/euw141. Epub 2016 Aug 18. PubMed 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.2025.05.029. Epub 2025 Jun 1. PubMed 40579293 ↗
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Registry details

Key details

Study ID
NCT06348394
Lead sponsor
Baylor Research Institute
Responsible party
Sponsor
First posted
Apr 4, 2024
Start date
Feb 25, 2025
Primary completion
Dec 30, 2030 (estimated)
Completion
Dec 30, 2030 (estimated)
Last update
Sep 3, 2026

Study contacts

Bonnie Ostergren
Contact
Bonnie.Ostergren@BSWHealth.org
4698144181

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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