An interventional study of Driver ablation+CPVI and Stepwise ablation in Atrial Fibrillation, Persistent, sponsored by Shanghai Chest Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-06.
Sponsored by Shanghai Chest Hospital · Not applicable, Interventional, and Treatment
This is an open label, multi-center, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.
This is an open label, multi-center, randomized parallel control clinical trial. Patients with persistent atrial fibrillation are 1:1 randomized into the experimental group (driver ablation+ circumferential pulmonary vein isolation) or the control group (stepwise ablation). Postoperative atrial fibrillation recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 1,298 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Driver ablation plus CPVI (circumferential pulmonary vein isolation)
Procedure: Driver ablation+CPVI
Stepwise ablation
Procedure: Stepwise ablation
Patients receive driver ablation and CPVI (circumferential pulmonary vein isolation).
Patients receive stepwise ablation.
Postoperative atrial fibrillation (AF) recurrence rate
AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration.
Time frame: up to 24 months after enrollment
Procedural AF termination rate
AF termination is defined as conversion to sinus rhythm or a stable atrial flutter (AFL)/atrial tachycardia (AT).
Time frame: Before the end of procedure.
Postoperative atrial flutter (AFL) or atrial tachycardia (AT) rate
Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration.
Time frame: up to 24 months after enrollment
Incidence of complications
Complications include: death, atrioesophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, transient ischemic attack (TIA), diaphragmatic paralysis, pneumothorax, heart block, pulmonary vein stenosis, pulmonary edema, pericarditis, and major vascular access complication or bleeding.
Time frame: up to 2 weeks after enrollment
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Shanghai Chest Hospital