Combining Left Atrial Appendage Closure With Cryoballoon Ablation in Chinese Population

Recruiting

• Conditions: Atrial Fibrillation
• Interventions: Combination Product: cryoballoon ablation combining with left atrial appendage closure

• Registration Number: NCT04185142
• Lead Sponsor: Shanghai 10th People's Hospital

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.

Study Timeline

• Study Start: 2015-10-16
• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-11-30
• Study First Posted: 2019-12-04
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-10-03
• Primary Completion: 2023-11-16
• Study Completion: 2024-11-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
combined procedure group	cryoballoon ablation combining with left atrial appendage closure	patients underwent cryoballoon ablation and left atrial appendage closure

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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
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
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
Rehospitalization due to cardiovascular events	Since the start of the procedure to 5 years.	Inpatient admission or emergency department admission with cardiovascular causes.
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
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
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.
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.
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.

Trial Locations

Locations (1)

Department of Cardiology, Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China