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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBCT guidance group

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

Group Type EXPERIMENTAL

cone-beam computed tomography fusion image

Intervention Type PROCEDURE

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

Interventions

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cone-beam computed tomography fusion image

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No