Comparing CT and DSA for selecting LAA occluder sizes in heart procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the accuracy of two imaging techniques, cardiac Computed Tomography (CT) and Digital Subtraction Angiography (DSA), in selecting the appropriate size of left atrial appendage (LAA) occluders during a combined procedure for atrial fibrillation ablation and LAA occlusion. Patients scheduled for this procedure will be randomly assigned to one of the two imaging groups. The study aims to determine which method provides better measurements for LAA occluder size selection, potentially improving outcomes for patients undergoing these cardiac interventions. Follow-up assessments will be conducted before discharge and at 3 months post-surgery, with additional long-term follow-up via telephone for up to 5 years.

Why it matters

Who can join: the full rules

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.

Where it's running

• First Affiliated Hospital of Shantou University Medical College
  Shantou, Guangdong, China Recruiting
• 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
• Guangdong Provincial Zhongshan Hospital of Traditional Chinese Medicine
  Zhongshan, Guangdong, China Not yet recruiting

Study contacts

• Study coordinator: Zhongbo Xiao, MD
• Email: 307523577@qq.com

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.