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Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion

ConditionLeft Atrial Appendage Closure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorBaylor Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intracardiac Echocardiography

    Device

    Transesophageal echocardiography will be performed under general anesthesia.

  • Traditional transesophageal echocardiography

    Device

    Traditional transesophageal echocardiography guided Left atrial appendage closure

Treatment groups

444 Participants
are divided into 2 treatment groups
Group A: Intracardiac echocardiography Left atrial appendage closure.Active comparator 1 intervention
Group B: Traditional transesophageal echocardiography guided Left atrial appendage closurePlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baylor Research Institute

Lead sponsor

Source ClinicalTrials.gov
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