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.
Study Type
OBSERVATIONAL
Enrollment
150
cryoballoon ablation using either 1st or 2nd generation of cryoballoon and left atrial appendage closure using devices including WATCHMAN, Lefort and Lacbes.
Department of Cardiology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGRecurrence 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.
Time frame: 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.
Time frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
All-cause death
Death event due to any cause
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.
Peripheral vascular embolism
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Arterial or venous thrombosis except cardiac or cerebral vascular embolism confirmed by imaging examination.
Time frame: 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.
Time frame: Since the start of the procedure to 5 years.
Redo-ablation
Ablation intended to treat recurrent atrial arrhythmia
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.