PLoS ONE (Jan 2024)

Cardiac prehabilitation, rehabilitation and education in first-time atrial fibrillation (AF) ablation (CREED AF): Study protocol for a randomised controlled trial.

  • Nakul Chandan,
  • Violet Matthews,
  • Hejie He,
  • Thomas Lachlan,
  • Ven Gee Lim,
  • Shivam Joshi,
  • Siew Wan Hee,
  • Angela Noufaily,
  • Edward Parkes,
  • Shilpa Patel,
  • Lazaros Andronis,
  • Joanna Shakespeare,
  • Helen Eftekhari,
  • Asad Ali,
  • Gordon McGregor,
  • Faizel Osman

DOI
https://doi.org/10.1371/journal.pone.0310951
Journal volume & issue
Vol. 19, no. 10
p. e0310951

Abstract

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BackgroundAtrial fibrillation (AF) is associated with significant morbidity/mortality. AF-ablation is an increasingly used treatment. Currently, first-time AF-ablation success is 40-80% at 1-year, depending on individual factors. There is growing evidence for improved outcomes through management of AF risk-factors/comorbidities via patient education/exercise-rehabilitation. There are no studies assessing combined prehabilitation/rehabilitation in this cohort. The aim of this randomised controlled trial is to assess efficacy of comprehensive prehabilitation/rehabilitation and combining supervised exercise-training with AF risk-factor modification/education compared with standard care in people undergoing first-time AF ablation.MethodsThis single-centre pragmatic randomised controlled trial will recruit 106 adults with paroxysmal/persistent AF listed for first-time AF-ablation. Participants will be randomised 1:1 to cardiac prehabilitation/rehabilitation/education (CREED AF) intervention or standard care. Both groups will undergo AF-ablation at 8-weeks post-randomisation as per usual care. The CREED AF intervention will involve 6-weeks of prehabilitation (before AF-ablation) followed by 6-weeks rehabilitation (after AF-ablation) consisting of risk factor education/modification and supervised exercise training. Standard care will include a single 30-minute session of risk-factor education. Outcomes will be measured at baseline, 10-weeks and 12-months post AF-ablation, by researchers blinded to treatment allocation. The primary outcome is cardiorespiratory-fitness (peak oxygen uptake, VO2peak) assessed using cardiopulmonary exercise testing (CPET) at 10-weeks post-ablation. Secondary outcomes include health-related quality of life, AF recurrence/burden assessed by 7-day Holter-monitor, requirement for repeat AF-ablation, study defined major adverse cardiovascular events, and cost-effectiveness (incremental cost per quality-adjusted life year (QALY)).ConclusionsThis study will assess clinical-efficacy/cost-effectiveness of comprehensive prehabilitation/rehabilitation/patient-education for people undergoing first time AF-ablation. Results will inform clinical care and design of future multi-centre clinical trials.Trial registrationURL: https://www.clinicaltrials.gov; Unique identifier: NCT06042231.Date registered: September 18, 2023.