Actively Recruiting
Accuracy of LAA Occluder Size Selection: CT vs. DSA During Combined AF Ablation and LAA Occlusion
Led by First Affiliated Hospital of Shantou University Medical College · Updated on 2024-06-12
238
Participants Needed
5
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Accuracy of LAA Occluder Size Selection: CT vs. DSA During Combined AF Ablation and LAA Occlusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with non-valvular atrial fibrillation and scheduled for atrial fibrillation ablation and percutaneous left atrial appendage occlusion
- Able to understand the trial purpose, willing to participate, and have signed informed consent
- Willing to complete follow-up according to the study protocol
You will not qualify if you...
- Allergy to contrast agents or conditions preventing cardiac CT or DSA imaging
- Lack of clear images to measure the left atrial appendage diameter on CT scans
- Presence of blood clots in the left atrium or left atrial appendage on imaging
- Valvular atrial fibrillation such as mechanical valve replacement or moderate to severe mitral stenosis with atrial fibrillation
- Left atrial appendage depth less than 15 mm, or anchor zone diameter less than 10 mm or greater than 33 mm
- Female patients of childbearing age planning pregnancy during the study follow-up
- Currently enrolled in another clinical trial that may interfere with this study
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Foshan Nanhai District People's Hospital
Foshan, Guangdong, China
Not Yet Recruiting
2
The Second People's Hospital of Foshan
Foshan, Guangdong, China
Not Yet Recruiting
3
Meizhou Hospital of Traditional Chinese Medicine
Meizhou, Guangdong, China
Not Yet Recruiting
4
First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
Actively Recruiting
5
Guangdong Provincial Zhongshan Hospital of Traditional Chinese Medicine
Zhongshan, Guangdong, China
Not Yet Recruiting
Research Team
Z
Zhongbo Xiao, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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