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
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Foshan Nanhai District People's Hospital
NOT_YET_RECRUITING
Foshan
The Second People's Hospital of Foshan
NOT_YET_RECRUITING
Foshan
Meizhou Hospital of Traditional Chinese Medicine
NOT_YET_RECRUITING
Meizhou
First Affiliated Hospital of Shantou University Medical College
RECRUITING
Shantou
Guangdong Provincial Zhongshan Hospital of Traditional Chinese Medicine
NOT_YET_RECRUITING
Zhongshan
Contact Information
Primary
Zhongbo Xiao, MD
307523577@qq.com
Time Frame
Start Date: 2024-07
Estimated Completion Date: 2031-07
Participants
Target number of participants: 238
Treatments
Experimental: CT group
CT-Guided Size Selection for LAA Occluder
Active_comparator: DSA group
DSA-Guided Size Selection for LAA Occluder
Related Therapeutic Areas
Sponsors
Leads: First Affiliated Hospital of Shantou University Medical College

This content was sourced from clinicaltrials.gov