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Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion

Not Applicable
Active, not recruiting
Conditions
Left Atrial Appendage Closure
Interventions
Other: Intracardiac Echocardiography
Registration Number
NCT06348394
Lead Sponsor
Baylor Research Institute
Brief 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.

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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
444
Inclusion Criteria
  1. Patients diagnosed for non-valvular atrial fibrillation with elevated CHADSVASC and HASBLED scores, meeting commercial LAAO criteria indications, who underwent appropriate pre-procedural imaging with Computed tomography or transesophageal echocardiography.
  2. Patients with increased risk of stroke with elevated CHA2DS2-VASc score.
  3. Patients who cannot be on oral anticoagulants or can't tolerate these medications.
  4. Patient should be able to comply with the protocol.
  5. Provide written informed consent before study participation.
  6. Ages 18 and above

Exclusion 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 left ventricle dysfunction- Left ventricular ejection fraction (LVEF < 40%) or greater than moderate valvular heart disease.
  4. Enrollment in another study that competes or interferes with this study.
  5. Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests.
  6. Subject with planned complex PCI or procedure necessitating multiple intervention.
  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. 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.
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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intracardiac echocardiography Left atrial appendage closure.Intracardiac EchocardiographyIntra cardiac echocardiography will be performed prior to left atrial appendage closure.
Traditional transesophageal echocardiography guided Left atrial appendage closureIntracardiac EchocardiographyTransesophageal Echocardiography will be performed under general anesthesia.
Primary Outcome Measures
NameTimeMethod
Procedural success following implantation of the left atrial appendage occlusion (LAAO) device.Intra op

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)

Secondary Outcome Measures
NameTimeMethod
Periprocedural complications45 days after the procedure

Death measured as (Yes/No)

Patient satisfaction45 days after the procedure

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

Procedural characteristics45 days after the procedure

Length of hospital stay measured as number of days.

Trial Locations

Locations (1)

Baylor Scott and White Heart Hospital

🇺🇸

Plano, Texas, United States

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