Abstract
Background: Atrial 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.
Methods: This 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, VO 2peak) 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)).
Conclusions: This 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.
| Original language | English |
|---|---|
| Article number | e0310951 |
| Number of pages | 15 |
| Journal | PLoS ONE |
| Volume | 19 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - 3 Oct 2024 |
Bibliographical note
Copyright: © 2024 Chandan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.Funder
BosBoston Scientific are pleased to confirm the funding of the research grant for CREED AF. As outlined in the agreement, Boston Scientific Limited shall pay the Grant Recipient, the total grant sum of £297,191.37 provided that funding reports are satisfactory and received as outlined.Funding
Boston Scientific are pleased to confirm the funding of the research grant for CREED AF. As outlined in the agreement, Boston Scientific Limited shall pay the Grant Recipient, the total grant sum of £297,191.37 provided that funding reports are satisfactory and received as outlined.
| Funders |
|---|
| Boston Scientific |
UN SDGs
This output contributes to the following UN Sustainable Development Goals (SDGs)
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SDG 3 Good Health and Well-being
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