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

Baylor Scott and White Health (BSWH)

Status: Active, not recruiting

Conditions: Left Atrial Appendage Closure

Treatments: Other: Intracardiac Echocardiography

Study type: Interventional

Funder types: Other

Identifiers

NCT06348394

023-318

Details and patient eligibility

About

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.

Full 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.

Enrollment: 444 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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444 participants in 2 patient groups, including a placebo group

Intracardiac echocardiography Left atrial appendage closure.

Active Comparator group

Description:

Intra cardiac echocardiography will be performed prior to left atrial appendage closure.

Treatment:

Other: Intracardiac Echocardiography

Traditional transesophageal echocardiography guided Left atrial appendage closure

Placebo Comparator group

Description:

Transesophageal Echocardiography will be performed under general anesthesia.

Treatment:

Other: Intracardiac Echocardiography