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

Cardiovascular Diseases Clinical Trial

Official title:

Combination of Cone Beam Computed Tomography and Cardiac Computed Tomography Angiography: Left Atrial Appendage Occlusion Under Three-dimensional Computed Tomography Fusion Image Guidance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05051280
• Other study ID #: CBCT-FIG-LAAO
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2021
• Source: RenJi Hospital
• Contact: JUN PU, Doctor
• Phone: 13817577592
• Email: Pujun310[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Procedure:
• cone-beam computed tomography fusion image
Left Atrial Appendage Occlusion Under Cone-beam Computed Tomography Fusion Image Guidance

Locations

Country	Name	City	State
China	Shanghai Jiaotong University School of Medcine, Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of success at first device selected	successful occluder deployment and release with no being resized	In surgery