NCT06455644

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 238 (estimated)
• Sponsor: First Affiliated Hospital of Shantou University Medical College · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	CT group	After completing the AF ablation, select the appropriate LAA occluder based on preoperative CT measurements for implantation.
OTHER	DSA group	After completing the AF ablation, select the appropriate LAA occluder based on intraoperative DSA measurements for implantation.

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-10-01
• Completion: 2031-07-01
• First posted: 2024-06-12
• Last updated: 2024-06-12

Locations

5 sites across 1 country: China