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

NCT06455644 | Recruiting

• 1 other identifier: B-2024-091
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 5

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

Keywords

Left atrial appendage closure; Atrial fibrillation; Pacifier-like occluder; Stroke prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Procedure success

  During procedure

• Peri-device leak at 3 months post-procedure

  3 months

• Procedure-related times

  During procedure

• Incidence of major adverse events (MAE) related to the device or procedure within 3 months post-procedure

  3 months

Study Arms (2)

CT group

EXPERIMENTAL

CT-Guided Size Selection for LAA Occluder

Other: CT group

DSA group

ACTIVE COMPARATOR

DSA-Guided Size Selection for LAA Occluder

Other: DSA group

Interventions

CT group OTHER

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

CT group

DSA group OTHER

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

DSA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• Patients with non-valvular atrial fibrillation scheduled to undergo atrial fibrillation ablation and percutaneous left atrial appendage occlusion;
• 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.

You may not qualify if:

• Allergy to contrast agents or other conditions that preclude cardiac CT or DSA imaging;
• Absence of clear images for measuring the diameter of the LAA in all layers of the CT scan;
• Imaging indicates the presence of thrombus in the left atrium or LAA;
• Patients with valvular AF (mechanical valve replacement or moderate to severe mitral stenosis combined with AF);
• LAA depth \< 15 mm, or LAA anchor zone diameter \< 10 mm or \> 33 mm;
• Female patients of childbearing age planning to become pregnant during the follow-up period required by this study;
• 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;
• Other conditions that the investigator deems make the participant unsuitable for this study.

Sponsors & Collaborators

• First Affiliated Hospital of Shantou University Medical College: lead

Study Sites (5)

Foshan Nanhai District People's Hospital

Foshan, Guangdong, China

NOT YET RECRUITING

The Second People's Hospital of Foshan

Foshan, Guangdong, China

NOT YET RECRUITING

Meizhou Hospital of Traditional Chinese Medicine

Meizhou, Guangdong, China

NOT YET RECRUITING

First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

RECRUITING

Guangdong Provincial Zhongshan Hospital of Traditional Chinese Medicine

Zhongshan, Guangdong, China

NOT YET RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zhongbo Xiao, MD

CONTACT

307523577@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 12, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): July 1, 2031
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

CN (5)