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RECRUITING
NCT06505798
NA

Cryoballoon/Radiofrequency/Pulsed Field Ablation of Atrial Fibrillation Versus Medical Treatment for Heart

Sponsor: University College, London

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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