An interventional study of Hybrid ablation and Thoracoscopic surgical ablation in Atrial Fibrillation, sponsored by Guangdong Academy of Medical Sciences. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-11.
Sponsored by Guangdong Academy of Medical Sciences · Not applicable, Interventional, and Treatment
Hybrid ablation, as an emerging strategy for atrial fibrillation (AF) in recent years, shows encouraging outcomes in many medical centers. A lot of cases demonstrated hybrid ablation has higher success rate than surgical ablation on patients with persistent AF, especially long-standing persistent AF (LSPAF). But it is still lack of high level evidence to prove it.
This study focus on patients with long-standing persistent atrial fibrillation (LSPAF). In order to compare the efficacy and safety of hybrid ablation (two-stage) versus thoracoscopic surgical ablation, a randomized, controlled clinical trial will be performed in the population of LSPAF patients.
In this study, all selected LSPAF patients will receive thoracoscopic surgical ablation. After 3 months of blanking-period, patients off antiarrhythmic therapy freedom from atrial arrhythmia (including atrial tachycardia, atrial flutter and atrial fibrillation) will be divided into Hybrid group and Surgical group randomly and equally. Patients of Hybrid group will receive transcatheter endocardial electrophysiological mapping and catheter ablation after randomization subsequently. In followed 2 years, cardiovascular risk control will be recommended to 2 groups' patients.
During the 2-year follow-up, 7d-Holter will be used to monitor patients' rhythm and cardiac conditions will be confirmed by transthoracic echocardiography (TTE). Physical examination and examinations mentioned above will be performed in 3 months, 6 months, 12 months, 18 months, 24 months and suspected recurrence.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 150 is close to the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Guangdong Academy of Medical Sciences is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
After thoracoscopic surgical ablation and 3 months of blanking-period, patients in this group will receive percutaneous catheter ablation and recommendations about cardiovascular risk control.
Procedure: Hybrid ablation
After thoracoscopic surgical ablation and 3 months of blanking-period, patients in this group will only receive recommendations about cardiovascular risk control.
Procedure: Thoracoscopic surgical ablation
This intervention including thoracoscopic surgical ablation, percutaneous catheter ablation and cardiovascular risk control.
This intervention including thoracoscopic surgical ablation and cardiovascular risk control.
Atrial tachyarrhythmia recurrence
Atrial arrhythmia (including atrial tachycardia, atrial flutter and atrial fibrillation) longer than 30s, off antiarrhythmic therapy, recorded by ECG or Holter.
Time frame: 24 months after blanking-period.
Systemic atrial embolism
Including cerebral infarction and other peripheral atrial embolism
Time frame: 24 months after blanking-period.
Left atrial thrombus
New-onset left atrial thrombus confirmed by TEE or TTE
Time frame: At 3months, 6months, 12months, 18months, 24months after intervention.
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Guangdong Academy of Medical Sciences