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Major trial tests if zapping heart tissue beats pills for common rhythm disorder

NCT ID NCT06505798

Disease control Sponsor: University College, London Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a procedure called catheter ablation (using heat or cold to fix faulty heart signals) is better than standard medications for people with both atrial fibrillation and heart failure. About 1,200 adults will be randomly assigned to receive either ablation plus medication or medication alone. The goal is to see if ablation reduces unplanned hospital visits and deaths over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation systolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation (AF)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Barts Health NHS Trust

    RECRUITING

    London, United Kingdom

  • Blackpool Victoria Hospital

    RECRUITING

    Blackpool, United Kingdom

  • Freeman Hospital, Royal Victoria Infirmary

    RECRUITING

    Newcastle, United Kingdom

  • Glenfield Hospital

    RECRUITING

    Leicester, United Kingdom

  • Golden Jubilee National Hospital

    RECRUITING

    Glasgow, G81 4DY, United Kingdom

  • Halifax Infirmary

    RECRUITING

    Halifax, Canada

  • Hull University Teaching Hospitals NHS Trust

    RECRUITING

    Hull, United Kingdom

  • Imperial College Healthcare NHS Trust

    RECRUITING

    London, United Kingdom

  • James Cook University Hosptial

    RECRUITING

    Middlesbrough, United Kingdom

  • Leeds Teaching Hospitals NHS Trust

    RECRUITING

    Leeds, United Kingdom

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    RECRUITING

    Liverpool, United Kingdom

  • Mid and South Essex NHS Foundation Trust

    RECRUITING

    Basildon, United Kingdom

  • Nottingham University Hospital NHS Trust

    RECRUITING

    Nottingham, United Kingdom

  • Queen Alexandra Hospital

    RECRUITING

    Portsmouth, United Kingdom

  • Queen Elizabeth Hospital

    RECRUITING

    Birmingham, United Kingdom

  • Royal Brompton and Harefields Hospitals

    RECRUITING

    London, UB9 6JH, United Kingdom

  • Royal Papworth Hospital NHS Foundation Trust

    RECRUITING

    Cambridge, CB2 0AY, United Kingdom

  • Southampton General

    RECRUITING

    Southampton, United Kingdom

  • St George's University Hospitals NHS Foundation Trust

    RECRUITING

    London, United Kingdom

  • St Thomas' hospital

    RECRUITING

    London, United Kingdom

  • Swansea Bay University Health Board

    RECRUITING

    Swansea, United Kingdom

  • University Hospitals Coventry and Warwickshire NHS Trust

    RECRUITING

    Coventry, United Kingdom

  • University Hospitals Dorset NHS Foundation Trust

    RECRUITING

    Bournemouth, United Kingdom

  • University Hospitals Plymouth NHS Trust

    RECRUITING

    Plymouth, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.