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Left Roof Linear, Mitral Isthmus Linear and Left Anterior Septal Linear Ablation for Non-paroxysmal AF: PROMISED Trial.

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Interventions: CPVI and LAAC (Procedure), PROMISED (Procedure) to CPVI and LAAC (Procedure), PROMISED (Procedure), Radiofrequency ablation catheter (Device), left atrial appendage occlusion device (Device)
    • Eligibility criteria shortened, about 24 words
    • Secondary endpoints: 9 to 11
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this prospective randomized study is to assess whether a new treatment strategy consisting of circumferential Pulmonary vein isolation (PVI), left ROof linear (RL), Mitral Isthmus linear (MIL), and left anterior SEptal linear (ASL) ablation and left atrial appendage (LAA) Device occlusion (PROMISED procedure) is superior to the PVI combined LAA closure in enhancing the long-term success rate of catheter ablation in non-paroxysmal atrial fibrillation (AF) patients.
Trial Details
NCT Number NCT06249347
Lead Sponsor Second Affiliated Hospital of Wenzhou Medical University
Conditions
(from sponsor)		 Atrial Fibrillation, Atrial Fibrillation, Persistent
Related terms Atrial Fibrillation
Enrollment 166 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov