Left Atrial Appendage Occlusion Under Cone-beam Computed Tomography Fusion Image Guidance

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Cardiovascular Diseases

Treatments: Procedure: cone-beam computed tomography fusion image

Study type: Interventional

Funder types: Other

Identifiers

NCT05051280

CBCT-FIG-LAAO

Details and patient eligibility

About

Left atrial appendage occlusion is being widely recommended as a treatment strategy for patients with nonvalvular AF to prevent stroke, especially those who cannot tolerate long-term oral anticoagulation or have other reasons for nonpharmacologic therapy. Currently, there are a number of guidance for left atrial appendage occlusion, such as transesophageal echocardiography, intracardiac echocardiogram, fluoroscopy, computed tomographic/computed tomographic angiography and so on. Procedures such as atrial septal puncture, device size selection and operational view are guided by different methods in various centers. Our center has developed a new approach to guidance: Cone-beam CT and cardiac computed tomographic angiography were combined by three-dimensional - three-dimensional image fusion in guiding left atrial appendage occlusion.

Full description

Eligible NVAF patients were recruited consecutively and received our LAAO workflow of local anesthesia, intracardiac echocardiography-guided transseptal puncture, and 3DCTA-3DCBCTF fusion-guided occluder implantation. The primary outcome was optimal occluder implantation (successful implantation with no occluder recapture and replacement). Other outcomes were procedure/fluoroscopic time, contrast agent consumption, radiation dose, and peri-procedure complications. We compared our results with existing publications of LAAO guided by 3DCTA and two-dimensional fluoroscopy (3DCTA-2DF) fusion images.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. An age of >18 years;
2. A CHA2DS2-VASc score of ≥2;
3. Clinical conditions allowing TEE and sedation;
4. Left ventricular ejection fraction >30%;
5. And at least one of the following indications: (a) HAS-BLED score of ≥3; (b) intolerance to long-term OAC, and (c) stroke, transient ischemic attack, or thromboembolism even under oral anticoagulation treatment;

Exclusion criteria

1. A glomerular filtration rate of <50 mL/min/1.73 m2;
2. The presence of a thrombus in the LA and LAA;
3. Acute myocardial infarction or unstable angina, decompensated heart failure (New York Heart Association functional class III-IV), or heart transplantation;
4. Stroke or transient ischemic attack within 30 days;
5. Very poor peripheral vessel access not allowing device delivery;
6. Moderate or massive pericardial effusion.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

CBCT guidance group

Experimental group

Description:

Left atrial appendage occlusion under cone-beam computed tomography fusion image guidance

Treatment:

Procedure: cone-beam computed tomography fusion image