Accuracy of LAA Occluder Size Selection: CT vs. DSA During Combined AF Ablation and LAA Occlusion

Cardiovascular Diseases Clinical Trial

Official title:

The Accuracy of Left Atrial Appendage Occluder Size Selection Between Preoperative CT and Intraoperative DSA Evaluation During a Combined Atrial Fibrillation Ablation and Left Atrial Appendage Occlusion Procedure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06455644
• Other study ID #: B-2024-091
• Status: Recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: July 2031

Study information

• Verified date: June 2024
• Source: First Affiliated Hospital of Shantou University Medical College
• Contact: Zhongbo Xiao, MD
• Email: 307523577[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a prospective, multi-center, randomized controlled trial. The subjects are patients scheduled to undergo a combined procedure of atrial fibrillation (AF) ablation and left atrial appendage (LAA) occlusion. After signing the informed consent form, the subjects will be randomly assigned to either the cardiac Computed Tomography (CT) group or the Digital Subtraction Angiography (DSA) group. The operator will select the appropriate LAA occluder size for implantation based on different measurement methods. All subjects will undergo clinical follow-up before discharge and at 3 months postoperatively, as well as telephone follow-up 1-5 years after the surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 238
• Est. completion date: July 2031
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years;

2. Patients with non-valvular atrial fibrillation scheduled to undergo atrial fibrillation ablation and percutaneous left atrial appendage occlusion;

3. Able to understand the purpose of the trial, willing to participate in the study, and the subject or their legal representative has signed the informed consent form, and is willing to complete the follow-up according to the protocol requirements.

Exclusion Criteria:

1. Allergy to contrast agents or other conditions that preclude cardiac CT or DSA imaging;

2. Absence of clear images for measuring the diameter of the LAA in all layers of the CT scan;

3. Imaging indicates the presence of thrombus in the left atrium or LAA;

4. Patients with valvular AF (mechanical valve replacement or moderate to severe mitral stenosis combined with AF);

5. LAA depth < 15 mm, or LAA anchor zone diameter < 10 mm or > 33 mm;

6. Female patients of childbearing age planning to become pregnant during the follow-up period required by this study;

7. Currently participating in another clinical trial of drugs or medical devices and has not yet completed the primary endpoints of that study, which may confound the results of this study or affect the participant's compliance with the follow-up;

8. Other conditions that the investigator deems make the participant unsuitable for this study.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Cardiovascular Diseases
• Heart Diseases

Intervention

Other:
• CT group
After completing the AF ablation, select the appropriate LAA occluder based on preoperative CT measurements for implantation.
• DSA group
After completing the AF ablation, select the appropriate LAA occluder based on intraoperative DSA measurements for implantation.

Locations

Country	Name	City	State
China	Foshan Nanhai District People's Hospital	Foshan	Guangdong
China	The Second People's Hospital of Foshan	Foshan	Guangdong
China	Meizhou Hospital of Traditional Chinese Medicine	Meizhou	Guangdong
China	First Affiliated Hospital of Shantou University Medical College	Shantou	Guangdong
China	Guangdong Provincial Zhongshan Hospital of Traditional Chinese Medicine	Zhongshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Shantou University Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of LAA occluder size selection	Accuracy is defined as: the occluder's anchor disc seats beyond the circumflex artery, the compression of the anchor disc after release is 3-6 mm, peri-device leak is = 3 mm, and the occluder remains stable during the tug test.	During procedure
Secondary	Procedure success	Technical success of the LAA occlusion procedure without serious procedure-related complications	During procedure
Secondary	Peri-device leak at 3 months post-procedure	Proportion of peri-device leak at the occluder evaluated by TEE or CT	3 months
Secondary	Procedure-related times	Total procedure time, AF ablation time, and LAA occlusion time	During procedure
Secondary	Incidence of major adverse events (MAE) related to the device or procedure within 3 months post-procedure	MAE is defined as unexplained death or any device or procedure-related complications, including but not limited to death, stroke, or transient ischemic attack (TIA), serious pericardial effusion/pericardial tamponade requiring pericardiocentesis or surgery, device embolization, life-threatening or severe bleeding events, and severe vascular access complications	3 months