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Recruiting INTERVENTIONAL NCT06348394

Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion (ICETEE)

Sponsor: Baylor Research Institute

Updated 5 times since 2024 Last updated: Apr 13, 2026 Started: Feb 25, 2025 Primary completion: Dec 14, 2026 Completion: Dec 30, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Left Atrial Appendage Closure, this trial is actively recruiting participants. The trial is conducted by Baylor Research Institute and has accumulated 5 data snapshots since 2025. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.

Study Description(click to expand)

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.

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.

Status Flow

~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jul 2025 · 10 months · monthly snapshotActive Not Recruiting~Jul 2025 – ~Apr 2026 · 9 months · monthly snapshotRecruitingApr 16, 2026 – present · 3 months · daily APIRecruiting

Change History

5 versions recorded
  1. Apr 16, 2026 — Present [daily]

    Recruiting

    Phase: NANone

  2. Jul 2025 — Apr 2026 [monthly]

    Recruiting NA

    Status: Active Not RecruitingRecruiting

  3. Sep 2024 — Jul 2025 [monthly]

    Active Not Recruiting NA

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting NA

  5. May 2024 — Jul 2024 [monthly]

    Active Not Recruiting NA

    First recorded

Eligibility 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.

Contact Information

Sponsor contact:
  • Baylor Research Institute
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations