Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion

Part of paid clinical trials in Plano, Texas.

Sponsor
Baylor Research Institute
Study ID
NCT06348394
Status
Recruiting
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Conditions

  • Left Atrial Appendage Closure

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 25, 2025
Status verified
Jun 2025
Primary completion
Dec 14, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
444 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Intracardiac echocardiography Left atrial appendage closure.
    Intra cardiac echocardiography will be performed prior to left atrial appendage closure.
  • Placebo Comparator: Traditional transesophageal echocardiography guided Left atrial appendage closure
    Transesophageal Echocardiography will be performed under general anesthesia.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor Scott and White Heart HospitalPlanoTexas75093
Bonnie Ostergren
[email protected]
4698144181
Sarah Hale
[email protected]
4698144845
Karim Al-Azizi, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Baylor Scott and White Heart Hospital· Plano, TX

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