Arrhythmias, Cardiac, Atrial Fibrillation, Cardiovascular Diseases, Heart Diseases
Conditions
Keywords
Left atrial appendage closure, Atrial fibrillation, Pacifier-like occluder, Stroke prevention
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.
Interventions
OTHERCT group
After completing the AF ablation, select the appropriate LAA occluder based on preoperative CT measurements for implantation.
OTHERDSA group
After completing the AF ablation, select the appropriate LAA occluder based on intraoperative DSA measurements for implantation.
Sponsors
First Affiliated Hospital of Shantou University Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of LAA occluder size selection | During procedure | Accuracy is defined as: the occluder's anchor disc seats beyond the circumflex artery, the compression of the anchor disc after release is 3-6 mm, peri-device leak is ≤ 3 mm, and the occluder remains stable during the tug test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure success | During procedure | Technical success of the LAA occlusion procedure without serious procedure-related complications |
| Peri-device leak at 3 months post-procedure | 3 months | Proportion of peri-device leak at the occluder evaluated by TEE or CT |
| Procedure-related times | During procedure | Total procedure time, AF ablation time, and LAA occlusion time |
| Incidence of major adverse events (MAE) related to the device or procedure within 3 months post-procedure | 3 months | MAE is defined as unexplained death or any device or procedure-related complications, including but not limited to death, stroke, or transient ischemic attack (TIA), serious pericardial effusion/pericardial tamponade requiring pericardiocentesis or surgery, device embolization, life-threatening or severe bleeding events, and severe vascular access complications |
Countries
China
Contacts
Primary ContactZhongbo Xiao, MD
Outcome results
None listed