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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Procedure: cone-beam computed tomography fusion image

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun Pu, Doctor; Phone Number: 13817577592; Email: Pujun310@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Shanghai Jiaotong University School of Medcine, Renji Hospital
      • Contact: Jun Pu, Doctor; Phone Number: 13817577592; Email: Pujun310@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of success at first device selected	successful occluder deployment and release with no being resized	In surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): August 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: September 12, 2021
• First Submitted That Met QC Criteria: September 12, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 12, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: CBCT-FIG-LAAO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No