Clinical Trials Directory

Trials / Unknown

UnknownNCT05051280

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

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
80 (estimated)
Sponsor
RenJi Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREcone-beam computed tomography fusion imageLeft Atrial Appendage Occlusion Under Cone-beam Computed Tomography Fusion Image Guidance

Timeline

Start date
2020-08-01
Primary completion
2024-08-31
Completion
2024-12-31
First posted
2021-09-21
Last updated
2021-09-21

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05051280. Inclusion in this directory is not an endorsement.