Actively Recruiting
Cryoballoon/Radiofrequency/Pulsed Field Ablation of Atrial Fibrillation Versus Medical Treatment for Heart
Led by University College, London · Updated on 2026-05-04
1200
Participants Needed
24
Research Sites
368 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cryoballoon/Radiofrequency/Pulsed Field Ablation of Atrial Fibrillation Versus Medical Treatment for Heart
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Willing and able to give informed consent
- Able and willing to follow all study requirements for at least 12 months
- Willing to allow their General Practitioner to be informed of their participation
- Diagnosed with paroxysmal AF lasting more than 6 hours and less than 7 days, or persistent AF lasting more than 7 days but less than 3 years
- Receiving optimal medical therapy for heart failure for at least 6 weeks, including recommended medications and devices as tolerated
- New York Heart Association class II to III
- Left ventricular ejection fraction below 50% documented within the past year after medical therapy optimization
- For LVEF 41-49% without ongoing atrial fibrillation/flutter, NT-proBNP of at least 300 pg/mL within 12 months prior to randomization
- For LVEF 41-49% with ongoing atrial fibrillation/flutter, NT-proBNP of at least 600 pg/mL within 12 months prior to randomization
- For LVEF 40% or less, NT-proBNP not required
You will not qualify if you...
- Long-standing persistent or permanent atrial fibrillation lasting more than 3 years
- Previous atrioventricular nodal ablation
- Previous pulmonary vein isolation or surgical ablation
- Recent (within 90 days) type 1 spontaneous myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, cardiac resynchronisation therapy, or stroke
- Severe aortic or pulmonary valve disease
- Severe primary or secondary mitral valve regurgitation
- Active illness (other than heart failure) expected to cause death within 2 years
- Pregnant or planning to become pregnant during the trial
- Breastfeeding
- Known allergy to contrast agents
- Contraindication for pulmonary vein isolation
- Other conditions preventing adherence to the trial protocol, as judged by the investigator
- Currently participating in another randomized controlled trial of a drug or medical device
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Halifax Infirmary
Halifax, Canada
Actively Recruiting
2
Mid and South Essex NHS Foundation Trust
Basildon, United Kingdom
Actively Recruiting
3
Queen Elizabeth Hospital
Birmingham, United Kingdom
Actively Recruiting
4
Blackpool Victoria Hospital
Blackpool, United Kingdom
Actively Recruiting
5
University Hospitals Dorset NHS Foundation Trust
Bournemouth, United Kingdom
Actively Recruiting
6
Royal Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom, CB2 0AY
Actively Recruiting
7
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, United Kingdom
Actively Recruiting
8
Golden Jubilee National Hospital
Glasgow, United Kingdom, G81 4DY
Actively Recruiting
9
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom
Actively Recruiting
10
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Actively Recruiting
11
Glenfield Hospital
Leicester, United Kingdom
Actively Recruiting
12
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, United Kingdom
Actively Recruiting
13
Royal Brompton and Harefields Hospitals
London, United Kingdom, UB9 6JH
Actively Recruiting
14
Barts Health NHS Trust
London, United Kingdom
Actively Recruiting
15
Imperial College Healthcare NHS Trust
London, United Kingdom
Actively Recruiting
16
St George's University Hospitals NHS Foundation Trust
London, United Kingdom
Actively Recruiting
17
St Thomas' hospital
London, United Kingdom
Actively Recruiting
18
James Cook University Hosptial
Middlesbrough, United Kingdom
Actively Recruiting
19
Freeman Hospital, Royal Victoria Infirmary
Newcastle, United Kingdom
Actively Recruiting
20
Nottingham University Hospital NHS Trust
Nottingham, United Kingdom
Actively Recruiting
21
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom
Actively Recruiting
22
Queen Alexandra Hospital
Portsmouth, United Kingdom
Actively Recruiting
23
Southampton General
Southampton, United Kingdom
Actively Recruiting
24
Swansea Bay University Health Board
Swansea, United Kingdom
Actively Recruiting
Research Team
P
Pier Lambiase
CONTACT
C
CRAAFT-HF Team @ Barts CVCTU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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