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Recruiting NCT05411614

NCT05411614 Hybrid Ablation of Atrial Fibrillation in Heart Failure

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Clinical Trial Summary
NCT ID NCT05411614
Status Recruiting
Phase
Sponsor St. George's Hospital, London
Condition Persistent Atrial Fibrillation
Study Type INTERVENTIONAL
Enrollment 120 participants
Start Date 2022-06-25
Primary Completion 2026-05

Trial Parameters

Condition Persistent Atrial Fibrillation
Sponsor St. George's Hospital, London
Study Type INTERVENTIONAL
Phase N/A
Enrollment 120
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-06-25
Completion 2026-05
Interventions
AtriCure EPi-Sense-AF Guided Coagulation System +/- AtriclipEndocardial Catheter Ablation

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Brief Summary

A randomised controlled trial to assess the efficacy of staged hybrid ablation when compared with standard catheter ablation in patients with non-paroxysmal atrial fibrillation (AF) and Heart Failure

Eligibility Criteria

Inclusion Criteria: * Age ≥ 18 years * Persistent or Long-standing Persistent AF * Dilated left atrium (at least moderately dilated) * Suitable for either procedure * LVEF \< 50% Exclusion Criteria: * Not yet optimised from a medical or lifestyle perspective for AF or heart failure * Unable to provide written consent * Previous open-heart surgery * Active infection, oesophageal ulcer stricture or oesophageal varices * Prior catheter ablation of atrial fibrillation (prior ablation for atrial flutter / supraventricular tachycardia or ventricular arrhythmia acceptable) * Contraindication to anticoagulation, or active thrombus in the left atrium despite therapeutic anticoagulation * Severe valvular heart disease * Unstable coronary artery disease * Uncontrolled ventricular arrhythmia * Heart attack or stroke within the last 90 days * Pregnant, breastfeeding, or women of childbearing age who plan to get pregnant within six months * Severe concomitant condition or presence of an implanted de

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