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

Not Applicable

Recruiting

• Conditions: Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac

• Registration Number: NCT06455644
• Lead Sponsor: First Affiliated Hospital of Shantou University Medical College

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-07
• Last Update Submitted: 2024-06-07
• Study First Posted: 2024-06-12
• Last Update Posted: 2024-06-12
• Study Start: 2024-07
• Primary Completion: 2026-10
• Study Completion: 2031-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 238

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Accuracy of LAA occluder size selection	During procedure	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.

Secondary Outcome Measures

Name	Time	Method
Procedure success	During procedure	Technical success of the LAA occlusion procedure without serious procedure-related complications
Peri-device leak at 3 months post-procedure	3 months	Proportion of peri-device leak at the occluder evaluated by TEE or CT
Procedure-related times	During procedure	Total procedure time, AF ablation time, and LAA occlusion time
Incidence of major adverse events (MAE) related to the device or procedure within 3 months post-procedure	3 months	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

Trial Locations

Locations (5)

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, China