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Cryoablation combined with left atrial appendage closure is a novel strategy for atrial fibrillation patients. Through long-term follow-up, the investigators aimed to observe the safety and efficacy of the combined procedure in Chinese population.
the investigators aimed to observe the clinical outcome of combining cryoballoon ablation (CBA) with left atrial appendage closure (LAAC) in drug-refractory non-valvular atrial fibrillation patients, who have high risk of stroke or hemorrhage, or contraindication of long-term oral anticoagulants (OACs).
The combined procedure was completed using CBA following LAAC. Generally, 3-month OACs, following 3-month double antiplatelet therapy, and lifelong single platelet therapy was recommended as antithrombotic regimen.
At 3rd,6th,12th and every year after since the procedure, Holter and transoesophageal echocardiography monitoring, and outpatient follow-up was applied to every patient.
The safety was evaluated by all-cause mortality, peri- and postprocedural complications. While the efficacy was evaluated through the freedom of atrial arrhythmia, stroke incidence, and withdrawal of OACs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combined procedure group | patients underwent cryoballoon ablation and left atrial appendage closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cryoballoon ablation combining with left atrial appendage closure | Combination Product | cryoballoon ablation using either 1st or 2nd generation of cryoballoon and left atrial appendage closure using devices including WATCHMAN, Lefort and Lacbes. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of atrial arrhythmia | The proportion of patients have recurrent atrial arrhythmia, including atrial tachycardia lasting longer than 30 seconds, atrial flutter, and atrial fibrillation. Detected by either ECG or 24 Holter monitor. | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. |
| Incidence of stroke | the proportion of patients have either hemorrhagic or ischemic stroke confirmed by CT or MRI. | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death | Death event due to any cause | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. |
| Cardiovascular death | death due to cardiovascular cause |
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Drug refractory non-valvular paroxysmal atrial fibrillation patients,
Inclusion Criteria:
Exclusion Criteria:
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Chinese with documented non-valvular atrial fibrillation who meet the inclusion criteria while without any of the exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhongyuan Ren, MD | Contact | +86 18862186450 | cloudyrzy@gmail.com | |
| Dongdong Zhao, MD, PhD | Contact | 249620601@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yawei Xu, MD, PhD | Department of Cardiology, Shanghai Tenth People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Shanghai Tenth People's Hospital | Recruiting | Shanghai | Shanghai Municipality | 200072 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36102232 | Derived | Ren Z, Zheng Y, Zhang J, Yang H, Wu J, Li H, Guo R, Meng W, Zhang J, Sun H, Xu Y, Zhao D. Patients With Larger Left Atrial Appendage Orifice Presented Worse Prognosis Contributed by Acute Heart Failure After Left Atrial Appendage Closure. J Am Heart Assoc. 2022 Sep 20;11(18):e026309. doi: 10.1161/JAHA.122.026309. Epub 2022 Sep 14. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000097546 | Left Atrial Appendage Closure |
| ID | Term |
|---|---|
| D006328 | Cardiac Catheterization |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. |
| Major hemorrhagic events | Intracranial hemorrhage, gastrointestinal bleeding, or any overt bleeding with hemoglobin drop ≥3 to 5 g/dL. | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. |
| Myocardial infarction | Diagnosed myocardial infarction with or without ST segment elevation. | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. |
| Peripheral vascular embolism | Arterial or venous thrombosis except cardiac or cerebral vascular embolism confirmed by imaging examination. | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. |
| Rehospitalization due to cardiovascular events | Inpatient admission or emergency department admission with cardiovascular causes. | Since the start of the procedure to 5 years. |
| Redo-ablation | Ablation intended to treat recurrent atrial arrhythmia | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. |
| Withdrawal of oral anticoagulants | The proportion of patients stop oral anticoagulation therapy including warfarin, dabigatran, or rivaroxaban. | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. |
| Residual flow | Residual flow between LAAC device and LAA measured by TEE | Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result. |
| LAAC device position | displacement of LAAC device evaluated by TEE | Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result. |
| Device related thrombus | Thrombus surrounding or attached to the LAAC device detected by TEE | Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result. |
| Atrioesophageal fistula | Fistula between left atrium and esophagus detected by TEE. | Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result. |
| Pericardial effusion | Any amount of pericardial effusion detected by TTE or TEE | Since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |