Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion

Conditions

• Left Atrial Appendage Closure

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• Intracardiac Echocardiography — DEVICE
  Transesophageal echocardiography will be performed under general anesthesia.
• Traditional transesophageal echocardiography — DEVICE
  Traditional transesophageal echocardiography guided Left atrial appendage closure

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

First listed

Apr 4, 2024

Start date

Feb 25, 2025

Status verified

Sep 2026

Primary completion

Dec 30, 2030

Completion

Dec 30, 2030

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

• Bonnie Ostergren
  4698144181
  [email protected]

Locations (1)

Find similar trials in Plano, TX

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