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Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
Cardiac prehabilitation, rehabilitation and education in first-time atrial fibrillation (AF) ablation (CREED AF):
Nakul Chandan1,2, Violet Matthews1,3, Hejie He1,4
1Institute for Cardio-Metabolic Medicine, University Hospital Coventry, Coventry, United Kingdom.
Insights
This study investigates a comprehensive prehabilitation and rehabilitation program combined with risk factor modification for atrial fibrillation (AF) patients undergoing ablation. The program aims to improve patient outcomes and cost-effectiveness compared to standard care.
Area of Science:
- Cardiology
- Clinical Trials
- Preventive Medicine
Background:
- Atrial fibrillation (AF) presents significant morbidity and mortality risks.
- First-time AF ablation success rates vary (40-80%), highlighting the need for improved patient management.
- Evidence suggests managing AF risk factors through education and exercise improves outcomes, but combined prehabilitation/rehabilitation has not been studied.
Purpose of the Study:
- To assess the efficacy of a comprehensive prehabilitation and rehabilitation program combined with risk factor modification and education for patients undergoing first-time AF ablation.
- To compare this intervention against standard care in a randomized controlled trial.
- To evaluate the cost-effectiveness of the intervention.
Main Methods:
- A single-centre pragmatic randomized controlled trial involving 106 adults with AF undergoing first-time ablation.
- Participants randomized to either the cardiac prehabilitation/rehabilitation/education (CREED AF) intervention or standard care.
- The CREED AF intervention includes 6 weeks of prehabilitation and 6 weeks of rehabilitation with supervised exercise and risk factor management; standard care involves a single risk factor education session.
Main Results:
- Primary outcome: cardiorespiratory fitness (VO2peak) measured by CPET at 10 weeks post-ablation.
- Secondary outcomes: quality of life, AF recurrence/burden (7-day Holter), repeat ablation rates, major adverse cardiovascular events, and cost-effectiveness (QALY).
- Outcomes assessed at baseline, 10 weeks, and 12 months by blinded researchers.
Conclusions:
- This study will determine the clinical efficacy and cost-effectiveness of comprehensive prehabilitation, rehabilitation, and patient education for first-time AF ablation patients.
- Results are expected to inform clinical practice and future multi-centre trial designs.
- The findings will contribute to optimizing AF management strategies.
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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