Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Catheter Ablation
  • Persistent Atrial Fibrillation
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

The PROMPT-AF study will include 288 patients undergoing their first catheter ablation of PeAF. All patients will be randomized to either the upgraded '2C3L' arm or PVI arm in a 1:1 fashion. The upgraded '2C3L' technique is a fixed ablation approach consisting of EI-VOM, bilateral circumferential PV...

The PROMPT-AF study will include 288 patients undergoing their first catheter ablation of PeAF. All patients will be randomized to either the upgraded '2C3L' arm or PVI arm in a 1:1 fashion. The upgraded '2C3L' technique is a fixed ablation approach consisting of EI-VOM, bilateral circumferential PVI and three linear ablation lesion sets across the mitral isthmus, left atrial roof, and cavo-tricuspid isthmus. The follow-up duration is 12 months. The primary endpoint is freedom from any documented atrial tachycardia arrhythmias of > 30 seconds from 3 to 12 months after a single ablation procedure (including a blanking period of 3 months) off antiarrhythmic drugs.

Tracking Information

NCT #
NCT04497376
Collaborators
  • Heart Health Research Centre
  • The George Institute for Global Health, China
  • The George Institute for Global Health, Australia
  • Fukuoka University
Investigators
Principal Investigator: Changsheng Ma, Doctor Beijing Anzhen Hospital Principal Investigator: Jianzeng Dong Dong, Doctor Beijing Anzhen Hospital; The First Affiliated Hospital of Zhengzhou University Principal Investigator: Caihua Sang, Doctor Beijing Anzhen Hospital
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