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

Sponsor: University College, London

NCT ID: NCT06505798

View on ClinicalTrials.gov ↗

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.

Atrial Fibrillation (AF)

How this trial compares with your answers

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What we know so far

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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
Inclusion criteria: 1. Patients aged ≥18 years. 2. Patient is willing and able to give informed consent for participation. 3. Able and willing to comply with all study requirements, including ability to participate in study for 12 months. 4. Willing to allow their General Practitioner (GP) to be notified of participation in the study. 5. Patient with one of the following AF categories and at least one episode of AF documented (by any means eg ECG, Holter, Cardiac Implantable Electronic Device (CIED) interrogation or any other means): * Paroxysmal AF defined as spontaneous self-terminating AF lasted \> 6 hours and \<7 days. * Persistent AF as defined by at least one episode of AF \>7 days but not \>3 years (since 1st documentation) 6. Optimal tolerated medical therapy for HF (including ACE-I (or ARB or ARNi), beta-blocker, SGLT2 inhibitor and mineralocorticoid receptor antagonist (MRA) and cardiac resynchronisation therapy (CRT) where indicated \& tolerated) for at least 6 weeks (according to the most contemporary European Society of Cardiology (ESC) HF guidelines). Maximal doses of these drugs are not mandated. 7. New York Heart Association Classification (NYHA) class II to III 8. LVEF \<50% (Cardiac imaging report of LVEF\<50% within 1 year (by echocardiography, cardiac magnetic resonance imaging or nuclear cardiology assessment)) AND after optimisation of medical therapy (see previous definition). Note - a LVEF of \<50% must be documented by any cardiac imaging performed after optimisation of medical therapy. Documentation of other baseline echocardiographic parameters (eg LA volume, E/E' etc can be obtained from any echocardiogram within 2.5 years). This allows a handheld or echocardiogram focused on LVEF assessment. 1. For those with LVEF 41-49% and without ongoing atrial fibrillation/flutter, N-terminal pro B-type natriuretic peptide (NT-proBNP) of ≥300pg/mL is required within 12 months prior to randomisation. 2. For those with LVEF 41-49% and with ongoing atrial fibrillation/flutter, NTproBNP of ≥600pg/mL is required within 12 months prior randomisation. 3. For those with LVEF ≤40%, NTproBNP is not required Exclusion criteria: 1. Long standing (\>3 year) persistent or permanent AF. 2. Previous atrioventricular (AV) nodal ablation. 3. Previous pulmonary vein isolation (PVI) or surgical ablation. 4. Recent (\<90 days) (type 1 spontaneous) myocardial infarction (type 2 myocardial infarctions are not an exclusion criterion), percutaneous coronary intervention, coronary artery bypass grafting, cardiac resynchronisation therapy or stroke. 5. Severe aortic or pulmonary valve disease. 6. Severe primary or secondary mitral valve regurgitation. 7. Active illness (other than HF) likely to result in death within 2 years. 8. People who are pregnant or planning to become pregnant during the trial. 9. People who are breastfeeding. 10. Known allergy to contrast. 11. Contraindication for PVI. 12. Other conditions that may prevent subjects from adhering to the trial protocol, in the opinion of the investigator. 13. Currently participating in another randomised controlled trial of another drug or medical device.

Where Is This Study? (23 UK sites)

Mid and South Essex NHS Foundation Trust

Basildon, United Kingdom

Recruiting
Site contact (verified)
Neil SrinivasanPrincipal Investigator

Queen Elizabeth Hospital

Birmingham, United Kingdom

Recruiting
Site contact (verified)
Manish KallaPrincipal Investigator

Blackpool Victoria Hospital

Blackpool, United Kingdom

Recruiting
Site contact (verified)
Alison SeedPrincipal Investigator

University Hospitals Dorset NHS Foundation Trust

Bournemouth, United Kingdom

Recruiting
Site contact (verified)
Richard BalasubramaniamPrincipal Investigator

Royal Papworth Hospital NHS Foundation Trust

Cambridge CB2 0AY, United Kingdom

Recruiting
Site contact (verified)
Claire MartinPrincipal Investigator

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, United Kingdom

Recruiting
Site contact (verified)
Tarv DhanjalPrincipal Investigator

Golden Jubilee National Hospital

Glasgow G81 4DY, United Kingdom

Recruiting
Site contact (verified)
Roy GardnerPrincipal Investigator

Hull University Teaching Hospitals NHS Trust

Hull, United Kingdom

Recruiting
Site contact (verified)
Andrew ClarkPrincipal Investigator

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Recruiting
Site contact (verified)
Muzahir TayebjeePrincipal Investigator

Glenfield Hospital

Leicester, United Kingdom

Recruiting
Site contact (verified)
Louise ClaytonPrincipal Investigator

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, United Kingdom

Recruiting
Site contact (verified)
Rajiv SankaranarayananPrincipal Investigator

Royal Brompton and Harefields Hospitals

London UB9 6JH, United Kingdom

Recruiting
Site contact (verified)
Shouvik HaldarPrincipal Investigator

Barts Health NHS Trust

London, United Kingdom

Recruiting
Site contact (verified)
Shohreh HonarbakhshPrincipal Investigator

Imperial College Healthcare NHS Trust

London, United Kingdom

Recruiting
Site contact (verified)
Prapa KanagaratnamPrincipal Investigator

St George's University Hospitals NHS Foundation Trust

London, United Kingdom

Recruiting
Site contact (verified)
Mark GallagherPrincipal Investigator

St Thomas' hospital

London, United Kingdom

Recruiting
Site contact (verified)
Aldo RinaldiPrincipal Investigator

James Cook University Hosptial

Middlesbrough, United Kingdom

Recruiting
Site contact (verified)
Andrew ThornleyPrincipal Investigator

Freeman Hospital, Royal Victoria Infirmary

Newcastle, United Kingdom

Recruiting
Site contact (verified)
Moloy DasPrincipal Investigator

Nottingham University Hospital NHS Trust

Nottingham, United Kingdom

Recruiting
Site contact (verified)
Shahnaz Jamil-CopleyPrincipal Investigator

University Hospitals Plymouth NHS Trust

Plymouth, United Kingdom

Recruiting
Site contact (verified)
Sharon ManPrincipal Investigator

Queen Alexandra Hospital

Portsmouth, United Kingdom

Recruiting
Site contact (verified)
Senthil KirubakaranPrincipal Investigator

Southampton General

Southampton, United Kingdom

Recruiting
Site contact (verified)
John PaiseyPrincipal Investigator

Swansea Bay University Health Board

Swansea, United Kingdom

Recruiting
Site contact (verified)
Dewi M ThomasPrincipal Investigator

How to Get in Touch

Pier Lambiase

Sponsor contact

CONTACT

07977217787 p.lambiase@ucl.ac.uk

CRAAFT-HF Team @ Barts CVCTU

Sponsor contact

CONTACT

craaft-hf-cvctu@qmul.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-03