Actively Recruiting
Accuracy of Left Atrial Appendage Occluder Size Selection Using CT vs DSA During Combined Atrial Fibrillation 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
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with non-valvular atrial fibrillation who are scheduled to have a combined procedure involving atrial fibrillation ablation and left atrial appendage (LAA) occlusion. This prospective, multi-center, randomized controlled trial aims to compare two methods for selecting the size of the LAA occluder device during the procedure. The study is sponsored by the First Affiliated Hospital of Shantou University Medical College and seeks to evaluate the accuracy of size selection using two imaging approaches. Participants are randomly assigned to one of two groups: the CT group, where the LAA occluder size is chosen based on preoperative cardiac CT measurements, and the DSA group, where size selection is guided by intraoperative digital subtraction angiography (DSA) measurements. Both methods are used after completing the atrial fibrillation ablation. The trial measures various outcomes including the accuracy of occluder size selection during the procedure, procedural success, procedure-related times, and incidence of major adverse events within three months after the procedure. Participants will have clinical follow-ups before hospital discharge and at three months after surgery, with telephone follow-ups conducted annually for up to five years. The study monitors procedure success, device-related leaks at three months, and any major adverse events related to the device or procedure. The total participation duration can extend up to five years, allowing careful assessment of both immediate and longer-term outcomes.
CONDITIONS
Brief 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 scheduled for atrial fibrillation ablation and percutaneous left atrial appendage occlusion
- Able to understand the trial purpose and willing to participate with signed informed consent
- Willing to complete follow-up as required by the study protocol
You will not qualify if you...
- Allergy to contrast agents or inability to undergo cardiac CT or DSA imaging
- Lack of clear CT images for measuring the left atrial appendage diameter
- Presence of thrombus in the left atrium or left atrial appendage
- 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 study follow-up
- Currently enrolled in another clinical trial that may affect compliance or results
- Any other condition making the participant unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo atrial fibrillation ablation followed by left atrial appendage occlusion where the occluder size is selected based on either CT or DSA imaging methods.
1 procedure visit (in-person)
Duration - 3 months
Participants are monitored for procedure success, peri-device leak, and major adverse events related to the device or procedure.
Approximately 2 follow-up visits
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
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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