RecruitingNot ApplicableNCT06505798

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

Sponsor

University College, London

Enrollment

1,200 participants

Start Date

Nov 21, 2024

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation (AF)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares three types of catheter ablation procedures for atrial fibrillation (AF) in patients who also have heart failure: cryoballoon ablation (freezing), radiofrequency ablation (heat), and pulsed field ablation (electrical energy). All three destroy the heart tissue that causes irregular rhythms. The study compares these approaches against medication-only treatment to see which best helps patients with both AF and heart failure. **You may be eligible if...** - You are 18 or older with documented atrial fibrillation (paroxysmal or persistent, lasting up to 3 years) - You also have heart failure and are on optimal medications for heart failure for at least 6 weeks - Your heart failure is Class II or III (moderate — some symptoms with activity) - You are willing to attend follow-up visits for 12 months **You may NOT be eligible if...** - You have had prior ablation for AF - You have severe structural heart problems that require surgery - You are pregnant - You have contraindications to anticoagulation (blood thinners) - Your AF has been continuous for more than 3 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURECatheter 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(24)

Halifax Infirmary

Halifax, Canada

Mid and South Essex NHS Foundation Trust

Basildon, United Kingdom

Queen Elizabeth Hospital

Birmingham, United Kingdom

Blackpool Victoria Hospital

Blackpool, 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

Glenfield Hospital

Leicester, United Kingdom

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, 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

St Thomas' hospital

London, United Kingdom

James Cook University Hosptial

Middlesbrough, United Kingdom

Freeman Hospital, Royal Victoria Infirmary

Newcastle, United Kingdom

Nottingham University Hospital NHS Trust

Nottingham, United Kingdom

University Hospitals Plymouth NHS Trust

Plymouth, United Kingdom

Queen Alexandra Hospital

Portsmouth, United Kingdom

Southampton General

Southampton, United Kingdom

Swansea Bay University Health Board

Swansea, United Kingdom

View Full Details on ClinicalTrials.gov

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