Comparing CT and DSA for selecting LAA occluder sizes in heart procedures
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 testing whether using CT or DSA imaging helps doctors choose the right size of heart device for patients with atrial fibrillation who need a specific procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 238 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital of Shantou University Medical College Academic / other |
| Locations | 5 sites (Foshan, Guangdong and 4 other locations) |
| Trial ID | NCT06455644 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with non-valvular atrial fibrillation who are scheduled for both atrial fibrillation ablation and percutaneous LAA occlusion.
Not a fit: Patients with contraindications for imaging techniques, such as allergies to contrast agents or those with certain anatomical limitations, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the precision of LAA occluder size selection, potentially reducing complications and improving stroke prevention in patients with atrial fibrillation.
How similar studies have performed: While this approach is being evaluated in this trial, similar studies using imaging techniques for procedural planning have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Foshan, Guangdong and 4 other locations
- 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)
Study contacts
- Study coordinator: Zhongbo Xiao, MD
- Email: 307523577@qq.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.