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:10.1371/journal.pone.0310951

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

Centre for Healthcare and Communities

Research output: Contribution to journal › Article › peer-review

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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	https://doi.org/10.1371/journal.pone.0310951
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	Funder number
Boston Scientific

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Chandan, N., Matthews, V., He, H., Lachlan, T., Lim, V. G., Joshi, S., Hee, S. W., Noufaily, A., Parkes, E., Patel, S., Andronis, L., Shakespeare, J., Eftekhari, H., Ali, A., McGregor, G., & Osman, F. (2024). Cardiac prehabilitation, rehabilitation and education in first-time atrial fibrillation (AF) ablation (CREED AF): Study protocol for a randomised controlled trial. PLoS ONE, 19(10), Article e0310951. https://doi.org/10.1371/journal.pone.0310951

Chandan, N, Matthews, V, He, H, Lachlan, T, Lim, VG, Joshi, S, Hee, SW, Noufaily, A, Parkes, E, Patel, S, Andronis, L, Shakespeare, J, Eftekhari, H, Ali, A, McGregor, G & Osman, F 2024, 'Cardiac prehabilitation, rehabilitation and education in first-time atrial fibrillation (AF) ablation (CREED AF): Study protocol for a randomised controlled trial', PLoS ONE, vol. 19, no. 10, e0310951. https://doi.org/10.1371/journal.pone.0310951

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

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.",

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

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T1 - Cardiac prehabilitation, rehabilitation and education in first-time atrial fibrillation (AF) ablation (CREED AF)

T2 - Study protocol for a randomised controlled trial

AU - Chandan, Nakul

AU - Matthews, Violet

AU - He, Hejie

AU - Lachlan, Thomas

AU - Lim, Ven Gee

AU - Joshi, Shivam

AU - Hee, Siew Wan

AU - Noufaily, Angela

AU - Parkes, Edward

AU - Patel, Shilpa

AU - Andronis, Lazaros

AU - Shakespeare, Joanna

AU - Eftekhari, Helen

AU - Ali, Asad

AU - McGregor, Gordon

AU - Osman, Faizel

N1 - 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.

PY - 2024/10/3

Y1 - 2024/10/3

N2 - 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.

AB - 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.

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

Abstract

Bibliographical note

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Funding

UN SDGs

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