Cryoballoon/Radiofrequency Ablation of Atrial Fibrillation Versus Medical Treatment for Heart
NCT Number: NCT06505798
Acronym: CRAAFT-HF
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrial Fibrillation (AF)
Interventions: PROCEDURE: Catheter Ablation
Sponsor: University College, London
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-15
Completion Date: 2031-12-15

Summary:
Atrial fibrillation (AF) is a common heart rhythm disorder that causes an irregular heart beat and is a cause of heart failure (HF). Treatments include drugs to slow the heart rate, anti-arrhythmic drugs or ablation of the heart to help preserve normal rhythm. A number of trials have suggested that ablation may be superior to drug treatment to reduce hospitalisations or prevent early death. However, these studies have been small and the results not applicable to the general population with AF and heart failure in the UK. This international study will compare catheter ablation and optimal medical therapy versus optimal medical therapy alone to see if catheter ablation reduces unplanned heart failure hospitalisations and death rates and improves quality of life.

Primary Outcome Measures: Time to first all-cause death and urgent CV hospitalisation, The primary outcome (time to first all-cause death and urgent CV hospitalisation) will be summarised by randomised group and analysed using a Cox proportional hazards regression model for time to first event, adjusting for factors used to balance the randomisation., 2 years minimum (range: 2-5.5 years)
Secondary Outcome Measures: Total (first and recurrent) all-cause death and urgent cardiovascular hospitalisations., Total (first and recurrent) number of all-cause deaths and urgent cardiovascular-related hospitalisations. Joint frailty models will be used to analyse time to death and recurrent urgent CV hospitalisations simultaneously. Additionally, negative binomial regression will be used to analyse the number of recurrent urgent CV hospitalisations., 2 years minimum (range: 2-5.5 years)|QoL at 6 and 12 months assessed using the KCCQ-CSS., Quality of Life (QoL) at 6 and 12 months assessed using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS). Linear mixed effects regression models will be used to analyse repeated measurements of QoL. Scored from 0- 100, with a higher score indicating better health., 12 months|Time to all-cause death, Time to all-cause death will be analysed using Cox proportional hazards regression model for time to event, matching the primary outcome., 2 years minimum (range: 2-5.5 years)|Total (first and recurrent) all-cause death and urgent HF hospitalisations, Total (first and recurrent) number of all-cause deaths and urgent heart failure-related hospitalisations. Joint frailty models will be used to analyse time to death and recurrent urgent HF hospitalisations simultaneously. Additionally, negative binomial regression will be used to analyse the number of recurrent urgent HF hospitalisations., 2 years minimum (range: 2-5.5 years)|Cardiovascular death, Total number of cardiovascular-related deaths. Cox proportional hazards regression model for time to event, matching the primary outcome., 2 years minimum (range: 2-5.5 years)