Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Ablation, Cryoablation
Brief summary
This is a double blinded randomised placebo-controlled trial comparing the effects of catheter ablation (Cryoablation) versus a placebo procedure on atrial fibrillation burden, symptoms and quality of life
Interventions
PROCEDURECryoablation
Pulmonary vein isolation with cryoablation
PROCEDUREPlacebo
Placebo procedure
Sponsors
Eastbourne Cardiology Research Charity Fund
Medtronic
East Sussex Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than or equal to 18 years * Symptomatic paroxysmal or persistent atrial fibrillation despite at least one antiarrhythmic drug (AAD Type I or III, β-blocker or AAD intolerance). * Referred for catheter ablation
Exclusion criteria
* Long term persistent AF (continuous episode lasting more than 1) * Prior left atrium catheter or surgical atrial fibrillation ablation * Patients with other arrhythmias requiring ablative therapy * Left atrium (LA) ≥5.5 cm * Any cardiac surgery or percutaneous coronary intervention (PCI) within three months prior to enrolment. * Awaiting cardiac surgery or PCI * Myocardial infarction within three months prior to enrolment. * Stroke or transient ischemic attack (TIA) within three months prior to enrolment * Unstable angina * Any significant congenital heart defect corrected or not (including atrial septal defects or PV abnormalities) but not including patent foramen ovale. * Any condition contraindicating chronic anticoagulation * Any untreated or uncontrolled hyperthyroidism or hypothyroidism * Severe chronic kidney disease (stage V, requiring or almost requiring dialysis, glomerular filtration rate (GFR) \< 15 ml / min) * Patients with metallic prosthetic valves * Pregnant or breastfeeding women * Medical conditions limiting expected survival to \<1 year * History of claustrophobia or panic attacks * Left ventricular ejection fraction (LVEF) less than 35%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atrial fibrillation burden using continuous monitoring | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Time to asymptomatic atrial tachyarrhythmia stratified by length of episode | 6 months |
| Number of atrial arrhythmia ( symptomatic and asymptomatic) episodes stratified by length of episode | 6 months |
| Change in AF specific quality of life score between each group (AF-PROMS) | Baseline and 6 months |
| Time to symptomatic atrial tachyarrhythmia stratified by length of episode | 6 months |
| Comparison of medical treatment ( Antiarrhythmic drug use) | 6 months |
| Comparison of unscheduled use of health care services | 6 months |
| Number of procedure related complications / adverse events | 6 months |
| Change in health related quality of life in each group (36-Item Short Form Survey Instrument ) | Baseline and 6 months |
Countries
United Kingdom
Outcome results
None listed