Clinical trial NCT06455644: Accuracy of LAA Occluder Size Selection: CT vs. DSA During Combined AF Ablation and LAA Occlusion
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Keywords: Left atrial appendage closure
Atrial fibrillation
Pacifier-like occluder
Stroke prevention
Lead sponsor: First Affiliated Hospital of Shantou University Medical College
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Accuracy of LAA occluder size selection
timeFrame: During procedure
Secondary outcomes:
measure: Procedure success
timeFrame: During procedure
measure: Peri-device leak at 3 months post-procedure
timeFrame: 3 months
measure: Procedure-related times
timeFrame: During procedure
measure: Incidence of major adverse events (MAE) related to the device or procedure within 3 months post-procedure
timeFrame: 3 months
Other outcomes:
Locations:
city: Foshan
country: China
facility: Foshan Nanhai District People's Hospital
state: Guangdong
city: Foshan
country: China
facility: The Second People's Hospital of Foshan
state: Guangdong
city: Meizhou
country: China
facility: Meizhou Hospital of Traditional Chinese Medicine
state: Guangdong
city: Shantou
country: China
facility: First Affiliated Hospital of Shantou University Medical College
state: Guangdong
city: Zhongshan
country: China
facility: Guangdong Provincial Zhongshan Hospital of Traditional Chinese Medicine
state: Guangdong
Study officials:
References: