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

NCT ID: NCT06455644

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2031-07-31

Brief 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CT group

CT-Guided Size Selection for LAA Occluder

Group Type: EXPERIMENTAL

CT group

Intervention Type: OTHER

After completing the AF ablation, select the appropriate LAA occluder based on preoperative CT measurements for implantation.

DSA group

DSA-Guided Size Selection for LAA Occluder

Group Type: ACTIVE_COMPARATOR

DSA group

Intervention Type: OTHER

After completing the AF ablation, select the appropriate LAA occluder based on intraoperative DSA measurements for implantation.

Interventions

CT group

After completing the AF ablation, select the appropriate LAA occluder based on preoperative CT measurements for implantation.

Intervention Type: OTHER

DSA group

After completing the AF ablation, select the appropriate LAA occluder based on intraoperative DSA measurements for implantation.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Shantou University Medical College

OTHER

Sponsor Role: lead

Responsible Party

Zhongbo Xiao

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Foshan Nanhai District People's Hospital

Foshan, Guangdong, China

Site Status: NOT_YET_RECRUITING

The Second People's Hospital of Foshan

Foshan, Guangdong, China

Site Status: NOT_YET_RECRUITING

Meizhou Hospital of Traditional Chinese Medicine

Meizhou, Guangdong, China

Site Status: NOT_YET_RECRUITING

First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

Site Status: RECRUITING

Guangdong Provincial Zhongshan Hospital of Traditional Chinese Medicine

Zhongshan, Guangdong, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Zhongbo Xiao, MD

Role: CONTACT

307523577@qq.com

Facility Contacts

Bo Li, MD

Role: primary

Jianqiu Liang, MD

Role: primary

Bo Zhang, MD

Role: primary

Zhongbo Xiao, MD

Role: primary

Ziyang Hu, MD

Role: primary

Other Identifiers

B-2024-091

Identifier Type: -

Identifier Source: org_study_id