Atrial Fibrillation
Conditions
Keywords
Combined procedure, Cryoballoon ablation, Left atrial appendage closure, Chinese
Brief summary
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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTcryoballoon ablation combining with left atrial appendage closure
cryoballoon ablation using either 1st or 2nd generation of cryoballoon and left atrial appendage closure using devices including WATCHMAN, Lefort and Lacbes.
Sponsors
Shanghai 10th People's Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Drug refractory non-valvular paroxysmal atrial fibrillation patients, Inclusion Criteria: 1. CHA2DS2-VASc score≥2 or HAS-BLED score≥3, 2. having contraindications to long-term oral anticoagulants (OACs), 3. refuse OAC therapy despite explanation.
Exclusion criteria
1. thrombus in left atrium (LA) or left atrial appendage (LAA) presented and confirmed by transoesophageal echocardiograph (TEE), 2. oversized LA (LA diameter\>65mm by TTE) or LAA (LAA opening\>35mm) through TEE, 3. pericardial effusion (≥4mm by TTE or TEE), 4. hemodynamic unstable patients, 5. patients with active hemorrhagic diseases, 6. ischemic or hemorrhagic stroke within 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of atrial arrhythmia | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. | 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. |
| Incidence of stroke | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. | the proportion of patients have either hemorrhagic or ischemic stroke confirmed by CT or MRI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major hemorrhagic events | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. | Intracranial hemorrhage, gastrointestinal bleeding, or any overt bleeding with hemoglobin drop ≥3 to 5 g/dL. |
| Myocardial infarction | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. | Diagnosed myocardial infarction with or without ST segment elevation. |
| Peripheral vascular embolism | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. | Arterial or venous thrombosis except cardiac or cerebral vascular embolism confirmed by imaging examination. |
| Rehospitalization due to cardiovascular events | Since the start of the procedure to 5 years. | Inpatient admission or emergency department admission with cardiovascular causes. |
| Redo-ablation | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. | Ablation intended to treat recurrent atrial arrhythmia |
| All-cause death | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. | Death event due to any cause |
| Residual flow | Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result. | Residual flow between LAAC device and LAA measured by TEE |
| LAAC device position | Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result. | displacement of LAAC device evaluated by TEE |
| Device related thrombus | Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result. | Thrombus surrounding or attached to the LAAC device detected by TEE |
| Atrioesophageal fistula | Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result. | Fistula between left atrium and esophagus detected by TEE. |
| Pericardial effusion | Since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. | Any amount of pericardial effusion detected by TTE or TEE |
| Withdrawal of oral anticoagulants | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. | The proportion of patients stop oral anticoagulation therapy including warfarin, dabigatran, or rivaroxaban. |
| Cardiovascular death | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. | death due to cardiovascular cause |
Countries
China
Contacts
Primary ContactZhongyuan Ren, MD
Backup ContactDongdong Zhao, MD, PhD
Outcome results
None listed