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Cryoballoon/Radiofrequency/Pulsed Field Ablation of Atrial Fibrillation Versus Medical Treatment for Heart
Sponsor: University College, London
Summary
Atrial fibrillation (AF) is a common heart rhythm disorder that causes an irregular heart beat and is a cause of heart failure (HF). Treatments include drugs to slow the heart rate, anti-arrhythmic drugs or ablation of the heart to help preserve normal rhythm. A number of trials have suggested that ablation may be superior to drug treatment to reduce hospitalisations or prevent early death. However, these studies have been small and the results not applicable to the general population with AF and heart failure in the UK. This international study will compare catheter ablation and optimal medical therapy versus optimal medical therapy alone to see if catheter ablation reduces unplanned heart failure hospitalisations and death rates and improves quality of life.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1200
Start Date
2024-11-21
Completion Date
2031-12-15
Last Updated
2025-11-26
Healthy Volunteers
No
Conditions
Interventions
Catheter Ablation
Participants randomised to the catheter ablation arm will undergo Pulmonary Vein Isolation (PVI) which is the essential ablation intervention. The technique used will be at the discretion of the treating physician but may include Cryoballoon (Medtronic/Boston Scientific), Radiofrequency: CARTO (Biosense), pulsed field radiofrequency ablation, or Precision (Abbott Medical) electro-anatomical mapping systems. Additional ablation lesions may be delivered as preferred by the operator and will be documented. Electro-anatomical voltage maps will be collected (in SR/AF) and stored for later analysis.
Locations (14)
Mid and South Essex NHS Foundation Trust
Basildon, United Kingdom
University Hospitals Dorset NHS Foundation Trust
Bournemouth, United Kingdom
Royal Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, United Kingdom
Golden Jubilee National Hospital
Glasgow, United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Royal Brompton and Harefields Hospitals
London, United Kingdom
Barts Health NHS Trust
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
St George's University Hospitals NHS Foundation Trust
London, United Kingdom
Nottingham University Hospital NHS Trust
Nottingham, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom
Swansea Bay University Health Board
Swansea, United Kingdom