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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac
• Intervention / Treatment: Other: CT group; Other: DSA group

• Study Type: Interventional
• Enrollment (Estimated): 238
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhongbo Xiao, MD; Email: 307523577@qq.com

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China
      • Not yet recruiting
      • Foshan Nanhai District People's Hospital
      • Contact: Bo Li, MD
    • Foshan, Guangdong, China
      • Not yet recruiting
      • The Second People's Hospital Of Foshan
      • Contact: Jianqiu Liang, MD
    • Meizhou, Guangdong, China
      • Not yet recruiting
      • Meizhou Hospital of Traditional Chinese Medicine
      • Contact: Bo Zhang, MD
    • Shantou, Guangdong, China
      • Recruiting
      • First Affiliated Hospital of Shantou University Medical College
      • Contact: Zhongbo Xiao, MD
    • Zhongshan, Guangdong, China
      • Not yet recruiting
      • Guangdong Provincial Zhongshan Hospital of Traditional Chinese Medicine
      • Contact: Ziyang Hu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT group; CT-Guided Size Selection for LAA Occluder	Other: CT group; After completing the AF ablation, select the appropriate LAA occluder based on preoperative CT measurements for implantation.
Active Comparator: DSA group; DSA-Guided Size Selection for LAA Occluder	Other: DSA group; After completing the AF ablation, select the appropriate LAA occluder based on intraoperative DSA measurements for implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure success	Technical success of the LAA occlusion procedure without serious procedure-related complications	During procedure
Peri-device leak at 3 months post-procedure	Proportion of peri-device leak at the occluder evaluated by TEE or CT	3 months
Procedure-related times	Total procedure time, AF ablation time, and LAA occlusion time	During procedure
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Shantou University Medical College

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): July 1, 2031

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 7, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Stroke prevention; Left atrial appendage closure; Pacifier-like occluder
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: B-2024-091

Drug and device information, study documents

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