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The aim of this study is to evaluate the safety and effectiveness of repeat catheter ablation using pulsed field ablation technology in people with persistent atrial fibrillation who have had a previous ablation but continue to experience arrhythmias 

Research Objectives

Status

Current

Recruitment

Open

Total participants required

10

Study location

Wesley Research Institute, The Wesley Hospital and St Andrew's War Memorial Hospital

Study type

Industry Sponsored

Patient group

Adults with persistent atrial fibrillation who continue to have symptoms or recurrent abnormal heart rhythms after a previous catheter ablation and are undergoing a repeat ablation procedure.

About this clinical trial

This study is investigating the safety and effectiveness of two medical devices, called FARAWAVE™ and FARAPOINT™, when used together to treat persistent atrial fibrillation. The study is for people who have previously had a catheter ablation for atrial fibrillation, but whose abnormal heart rhythm has returned and continues to cause symptoms. 

Participants in this study require a repeat ablation procedure to help restore or maintain a normal heart rhythm. During the procedure, doctors will use a pulsed field ablation system, which delivers controlled electrical energy to target and treat areas of heart tissue responsible for the abnormal rhythm. 

The FARAPULSE™ Pulsed Field Ablation System is considered investigational for this specific use, meaning it is still being studied to better understand how well it works and how safe it is in repeat ablation procedures. The results of this study may help improve future treatment options for people with persistent atrial fibrillation.

Trial Registration Information – https://clinicaltrials.gov/study/NCT06735534

Eligibility

Self screening is not recommended for this study. Eligibility will be confirmed by the study doctor based on medical history and clinical assessment. 

Lead investigator

  • Dr Tomos Walters

Clinical trial coordinator

  • Linda Pearce

Technical title

Repeat Ablation of Persistent Atrial Fibrillation, including Mitral Isthmus and Cavo-Tricuspid Isthmus Ablations, with the FARAPULSE Pulsed Field Ablation System

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