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

Not Applicable

Recruiting

• Conditions: Cardiovascular Diseases
• Interventions: Procedure: cone-beam computed tomography fusion image

• Registration Number: NCT05051280
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-08-01
• Status Verified: 2021-09
• Study First Submitted: 2021-09-12
• Study First Submitted QC: 2021-09-12
• Last Update Submitted: 2021-09-12
• Study First Posted: 2021-09-21
• Last Update Posted: 2021-09-21
• Primary Completion: 2024-08-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CBCT guidance group	cone-beam computed tomography fusion image	Left atrial appendage occlusion under cone-beam computed tomography fusion image guidance

Primary Outcome Measures

Name	Time	Method
rate of success at first device selected	In surgery	successful occluder deployment and release with no being resized

Trial Locations

Locations (1)

Shanghai Jiaotong University School of Medcine, Renji Hospital; 🇨🇳 Shanghai, Shanghai, China