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. 2024 Oct 3;19(10):e0310951.
doi: 10.1371/journal.pone.0310951. eCollection 2024.

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

Nakul Chandan  1   2 , Violet Matthews  1   3 , Hejie He  1   4 , Thomas Lachlan  1   4 , Ven Gee Lim  1   4 , Shivam Joshi  1   3 , Siew Wan Hee  1   3 , Angela Noufaily  4 , Edward Parkes  1   4 , Shilpa Patel  1   4 , Lazaros Andronis  4 , Joanna Shakespeare  1   4 , Helen Eftekhari  1   4 , Asad Ali  1 , Gordon McGregor  1   2   4 , Faizel Osman  1   2   4
Affiliations

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

Nakul Chandan et al. PLoS One. .

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, 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)).

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.

Trial registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT06042231.Date registered: September 18, 2023.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Trial schedule of events (SPIRIT schedule).
Fig 2
Fig 2. Flowchart of the CREED AF study, demonstrating the patient pathway.
AF, atrial fibrillation; QoL, quality of life; RU, resource use; MACE, major adverse cardiovascular events.
Fig 3
Fig 3. Eligibility criteria.
See this image and copyright information in PMC

References

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