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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | cone-beam computed tomography fusion image | Left 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.