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

NCT05051280 | Unknown

• 1 other identifier: CBCT-FIG-LAAO
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• rate of success at first device selected

  successful occluder deployment and release with no being resized

  In surgery

Study Arms (1)

CBCT guidance group

EXPERIMENTAL

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

Procedure: cone-beam computed tomography fusion image

Interventions

cone-beam computed tomography fusion image PROCEDURE

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

CBCT guidance group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An age of \>18 years;
• A CHA2DS2-VASc score of ≥2;
• Clinical conditions allowing TEE and sedation;
• Left ventricular ejection fraction \>30%;
• 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;

You may not qualify if:

• A glomerular filtration rate of \<50 mL/min/1.73 m2;
• The presence of a thrombus in the LA and LAA;
• Acute myocardial infarction or unstable angina, decompensated heart failure (New York Heart Association functional class III-IV), or heart transplantation;
• Stroke or transient ischemic attack within 30 days;
• Very poor peripheral vessel access not allowing device delivery;
• Moderate or massive pericardial effusion.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Shanghai Jiaotong University School of Medcine, Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• JUN PU, Doctor

  Shanghai Jiao Tong University, School of Medicine, Affiliated Ren Ji Hospital

  STUDY CHAIR

Central Study Contacts

JUN PU, Doctor

CONTACT

13817577592; Pujun310@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2021
• First Posted: September 21, 2021
• Study Start: August 1, 2020
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)