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

Sponsor
RenJi Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05051280
Collaborator
(none)
80
Enrollment
1
Location
1
Arm
53
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: cone-beam computed tomography fusion image
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: CBCT guidance group

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

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

Outcome Measures

Primary Outcome Measures

  1. rate of success at first device selected [In surgery]

    successful occluder deployment and release with no being resized

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Jiaotong University School of Medcine, Renji Hospital Shanghai Shanghai China 200127

Sponsors and Collaborators

  • RenJi Hospital

Investigators

  • Study Chair: JUN PU, Doctor, Shanghai Jiao Tong University, School of Medicine, Affiliated Ren Ji Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RenJi Hospital
ClinicalTrials.gov Identifier:
NCT05051280
Other Study ID Numbers:
  • CBCT-FIG-LAAO
First Posted:
Sep 21, 2021
Last Update Posted:
Sep 21, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cardiovascular Diseases

Study Results

No Results Posted as of Sep 21, 2021