Cardiothoracic surgery Circulatory System
Conditions
Interventions
The study is a randomised controlled trial, comparing current best practice against the proposed treatment strategy. The procedure will be performed by a consultant cardiologist or specialist registra
Sponsors
University Hospitals Sussex NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Indicated for catheter ablation for documented symptomatic longstanding persistent AF (>12 months duration) 2. Aged >18 years 3. Willing and able to provide informed consent 4. Willing and able to comply with the study requirements
Exclusion criteria
Exclusion criteria: 1. Pregnancy or planning pregnancy 2. Previous AF/AT ablation 3. LA diameter >55 mm in TTE 4. Current involvement in another interventional clinical trial 5. Contraindication to anticoagulation 6. Longstanding persistent AF lasting more than 3 years in duration 7. Cyanotic congenital heart disease 8. Body Mass Index >40 kg/m² 9. No recent cardiac imaging (cardiac MRI or echocardiogram) 10. Severe valvular heart disease Intra-procedural exclusion criteria: Re-assessment of PVI after the 20-minute waiting period Post-procedural exclusion criteria: Implantable cardiac monitor permanently explanted, during the blanking period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from persistent atrial arrhythmia (persistent atrial fibrillation and atrial tachycardia) in Arms 1 and 2, from the end of the blanking period on implantable loop recorder monitoring, after a single procedure at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The occurrence of acute procedural complications and total mortality measured using reported adverse events at 12 and 24 months 2. Time free from persistent AF or AT on/off antiarrhythmic medication, with ‘survival’ time measured from the end of the blanking period using an implantable loop recorder 3. Time free from persistent AF or AT on/off antiarrhythmic medication, with ‘survival’ time measured from the time of the procedure using an implantable loop recorder. Cardioverted arrhythmias during the blanking will be excluded from this analysis. 4. Freedom from persistent AF or AT, assessed by continuous monitoring at 12 months following a single ablation procedure on anti-arrhythmics (AADs) 5. AF and AT burden on/off antiarrhythmic medication measured using implantable loop recorder at 12 and 24 months 6. AF episodes >30 seconds on/off antiarrhythmic medication measured using implantable loop recorder at 12 and 24 months 7. Successful bidirectional linear block in Arm 2 measured using mapping catheter at 20 months post ablation 8. Quality of life measured using EQ-5D and Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) at pre-procedure and 12 months 9. Number of repeat ablation procedures required, measured using reported information at 12 and 24 months | — |
Countries
Denmark, England, Germany, Ireland, United Kingdom
Contacts
Public ContactDuncan Fatz
Outcome results
None listed