At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Catheter Ablation (procedure)
- How long the study runs
- Study runs about 85 months (dates as stated)
- About the drug or intervention
- Catheter Ablation — procedure: Participants randomised to the catheter ablation arm will undergo Pulmonary Vein Isolation (PVI) which is the essential ablation intervention.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study compares three types of ablation treatment (cryoballoon, radiofrequency, or pulsed field ablation) with medicine-based treatment for people with atrial fibrillation (AF), a condition where the heart beats in an irregular rhythm. It is being run by University College, London. The study focuses on people who also have heart failure, which means the heart is not pumping as well as it should.
Who can take part
- Adults aged 18 or over who can give informed consent and follow the study requirements for 12 months
- People willing to let their GP (family doctor) know they are taking part
- People with atrial fibrillation (AF) that has been recorded on a heart test — either AF that stops on its own within 7 days, or AF lasting more than 7 days but not more than 3 years
- People already taking the best tolerated heart failure medicines for at least 6 weeks
- Heart failure symptoms rated as class II to III on the New York Heart Association scale (everyday activity causes some breathlessness or tiredness)
- A heart pumping strength (LVEF, a measure from a heart scan) of under 50%, recorded after heart failure medicines were optimised
- For people with LVEF between 41% and 49%, a blood test called NT-proBNP above a set level within the past 12 months is also needed
Who may not be able to
- AF that has lasted more than 3 years or permanent AF
- Previous ablation of the AV node (part of the heart's electrical system) or previous pulmonary vein isolation or surgical ablation
- A heart attack, stent procedure, heart bypass surgery, resynchronisation therapy, or stroke within the past 90 days
- Severe heart valve disease or severe mitral valve leak
- Another serious illness, other than heart failure, likely to cause death within 2 years
- People who are pregnant, planning pregnancy during the trial, or breastfeeding
- Known allergy to contrast dye, or any reason why the ablation procedure is not suitable
- Other conditions that, in the researcher's view, would stop someone following the study plan
- Currently taking part in another randomised trial of a drug or medical device
What taking part involves
- • Participants are placed in one of four groups: cryoballoon ablation, radiofrequency ablation, pulsed field ablation, or continued medical treatment
- • How each treatment is given and any extra procedures: Not stated — ask the trial team
Time commitment: Taking part lasts 12 months; full details of study visits and tests are not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,200
- Started
- 2024-11-21
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for atrial fibrillation (af)
- • NA - 1,200 participants
- • Atrial fibrillation (AF) is a common heart rhythm disorder that causes an irregular heart beat and is a cause of heart failure (HF)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with atrial fibrillation (af)
Where?
- • Basildon - Mid and South Essex NHS Foundation Trust
- • Birmingham - Queen Elizabeth Hospital
- • Blackpool - Blackpool Victoria Hospital
- • Bournemouth - University Hospitals Dorset NHS Foundation Trust
- • +19 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
Atrial fibrillation (AF) increases the severity of, and death from, heart failure (HF). Several small studies have demonstrated that restoration of sinus rhythm by catheter ablation in patients with HF improves left ventricular (LV) function and exercise tolerance. What is unknown is whether or not AF ablation reduces all-cause death and urgent CV hospitalisations in populations with HF. The current trial will answer this outstanding question, which is faced by HF clinicians and electrophysiologists on a daily basis. AF ablation can be performed very effectively and efficiently using a cryo-balloon or radio-frequency ablation PVI technique. These techniques have evolved slowly and are unlikely to change substantially over the course of this trial. One small trial (n=363) in implantable cardioverter-defibrillator and CRT defibrillator recipients (CASTLE-AF) reported a death benefit of AF ablation but the patients were highly selected and the death reduction was far higher than real world expected differences. Recent studies have noted that the population randomised in CASTLE-AF was not representative of the general HF population with only 7% of patients in the "real world" setting meeting the trial entry criteria. CASTLE-AF is therefore provocative but inconclusive; it has made little change to clinical practice. As no studies have investigated the death benefit in a general HF population, the proposed trial is necessary and warranted. This study is designed as a randomised, open label multicentre clinical trial in which catheter ablation and medical therapy is compared to medical therapy alone in patients with HF with reduced ejection fraction (\<50%) and paroxysmal or persistent AF to determine if this reduces all-cause death and urgent CV hospitalisations as well as improving QoL. By utilising the clinical and research networks of the British Heart Failure Society and British Heart Rhythm Society (BHRS) we will recruit 1200 patients. The current trial will be almost three times the size of the only previous inconclusive trial which was reported in the New England Journal of Medicine.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ within 12 months
- ✓ within 12 months prior randomisation
What the study is looking for
- ✓Patients aged ≥18 years.
- ✓Patient is willing and able to give agreement to take part for participation.
- ✓Able and willing to comply with all study requirements, including ability to participate in study for 12 months.
- ✓Willing to allow their General Practitioner (GP) to be notified of participation in the study.
- ✓Patient with one of the following AF categories and at least one episode of AF documented (by any means eg ECG,...
Who cannot take part
- ✗Long standing (\>3 year) persistent or permanent AF.
- ✗Previous atrioventricular (AV) nodal ablation.
- ✗Previous lung vein isolation (PVI) or surgical ablation.
- ✗Severe aortic or lung valve disease.
- ✗Severe primary or secondary mitral valve regurgitation.
See the full criteria
Where Is This Study? (23 UK sites)
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 CB2 0AY, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, United Kingdom
Golden Jubilee National Hospital
Glasgow G81 4DY, 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 UB9 6JH, 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
How to Get in Touch
Pier Lambiase
Sponsor contactCONTACT
CRAAFT-HF Team @ Barts CVCTU
Sponsor contactCONTACT
