Comparing catheter ablation (cryo, radiofrequency, pulsed field) with medical therapy for people with atrial fibrillation and heart failure.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial will compare catheter ablation (using cryoballoon, radiofrequency, or pulsed field pulmonary vein isolation) plus guideline-directed heart-failure therapy versus guideline-directed therapy alone in people with AF and heart failure. The primary outcomes include unplanned heart-failure hospitalisations and all-cause death, with quality-of-life and ventricular function as additional measures. Ablation is performed using established PVI techniques and patients are followed for at least 12 months to capture clinical events and patient-reported outcomes. The trial aims to enroll a broad, generalizable heart-failure population rather than the narrowly selected groups of prior small studies.

Why it matters

Who can join: the full rules

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 it's running

• Halifax Infirmary
  Halifax, Canada Recruiting
• Mid and South Essex NHS Foundation Trust
  Basildon, United Kingdom Recruiting
• Queen Elizabeth Hospital
  Birmingham, United Kingdom Recruiting
• Blackpool Victoria Hospital
  Blackpool, United Kingdom Recruiting
• University Hospitals Dorset NHS Foundation Trust
  Bournemouth, United Kingdom Recruiting
• Royal Papworth Hospital NHS Foundation Trust
  Cambridge, United Kingdom Recruiting

Study contacts

• Principal investigator: Pier Lambiase — University College, London
• Study coordinator: Pier Lambiase
• Email: p.lambiase@ucl.ac.uk
• Phone: 07977217787

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.