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This is a randomised, adaptive open label multicentre clinical trial which compares optimal medical therapy (as per standard of care) with catheter ablation plus optimal medical therapy alone in participants with HfrEF (LVEF<50%) and paroxysmal or persistent atrial fibrillation.
This design is adaptive in that the required sample size is reviewed in an interim analysis at 80% recruitment. This interim analysis aims to ensure that sufficient patients are recruited to maintain the conditional power of the study at 80% or higher. Options which can be deployed at the interim analysis include increasing patient numbers and increasing duration of follow up.
Participants randomised to the catheter ablation arm will undergo PVI which is the essential ablation intervention. The technique used will be at the discretion of the treating physician but may include Cryoballoon (Medtronic/Boston Scientific), Radiofrequency: CARTO (Biosense) or Precision (Abbott Medical) electro-anatomical mapping systems, pulsed field ablation (any CE marked system) with or without electroanatomical mapping. Additional ablation lesions may be delivered as preferred by the operator and will be documented. Electro-anatomical voltage maps will be collected (in SR/AF) and stored for later analysis. These will be uploaded to REDCap. Participants in the catheter ablation arm will also receive optimal medical therapy.
The study is compliant with the requirements of GCP, the UK General Data Protection Regulation (UK GDPR) and the UK Data Protection Act (2018). All Investigators and study site staff will comply with the requirements of UK GDPR with regards to the collection, storage, processing, and disclosure of personal information, and will uphold the Act’s core principles. UCL is the data controller. The study will be collecting the following personal data for the purpose of data linkage:
Patient name
Date of birth
Sex
Postcode
NHS/CHI number
And the below data for the purposes of inviting participants to complete study questionnaires. This data is held by QMUL via REDCap only:
Email address
Mobile phone number
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The CRAAFT-HF study is coordinated at Barts Cardiovascular Research Unit (CVCTU) in London and has been reviewed and approved by the Health Research Authority Research Ethics Committee London - Hampstead.
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