Cardiovascular disease Circulatory System
Conditions
Interventions
The study is a randomised controlled trial, comparing current best practices against the proposed treatment strategy. The procedure will be performed by a Consultant Cardiologist or Specialist Registr
Sponsors
University Hospitals Sussex NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Previous left atrial ablation with pulmonary vein isolation only 2. Indicated for repeat catheter ablation for documented symptomatic recurrent persistent AF 3. Aged > 18 years 4. Willing and able to provide informed consent 5. Willing and able to comply with the study requirements
Exclusion criteria
Exclusion criteria: 1. Pregnancy or planning pregnancy 2. Previous cardiac surgery 3. Previous pericarditis 4. Previous linear ablation in the LA 5. LA diameter > 55 mm in TTE 6. Current involvement in another interventional clinical trial 7. Contraindication to anticoagulation 8. Longstanding persistent AF lasting more than 2 years in duration 9. Cyanotic congenital heart disease 10. Body Mass Index > 40 11. Unable to use a smartphone with the ‘myMerlin’ application 12. Failure to achieve sinus rhythm, despite a maximum of 4x cardioversions +/- IV antiarrhythmic drugs 13. Failure to achieve epicardial access, via the CO2 insufflation technique 14. Re-assessment of PVI after the 20-minute waiting period 15. Implantable cardiac monitor permanently explanted, during the blanking period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 23/07/2025: Freedom from persistent atrial arrhythmia (persistent atrial fibrillation and left-sided atrial tachycardia) in Arms 1 and 2, on implantable loop recorder monitoring, after a single procedure off anti-arrhythmics at 12 months measured using patient records Previous primary outcome measure: Time free from documented persistent atrial fibrillation at 12 months measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 23/07/2025: The following secondary outcome measures will be reported for all patients after one trial procedure at 12 months and at completed data transmission (CDT) and measured using patient records: 1. Time free from persistent atrial arrhythmia on/off antiarrhythmic medication, with ‘survival’ time measured from time of procedure 2. Time free from persistent atrial arrhythmia on/off antiarrhythmic medication, with ‘survival’ time measured from end of the blanking period (3 months). Failures during blanking period to be considered as occurring at 3 months and 1 day 3. AF and AT burden on/off antiarrhythmic medication. 4. AF burden on/off antiarrhythmic medication. 5. AT burden on/off antiarrhythmic medication. 6. AF episodes > 30 seconds on/off antiarrhythmic medication. 7. Symptomatic AF episodes >30 seconds on/off antiarrhythmic medication. 8. AT episodes of >30 seconds on/off antiarrhythmic medication. 9. Symptomatic AT episodes >30 seconds on/off antiarrhythmic medication. 10. AF and AT episodes >30 seconds on/off antiarrhythmic medication. 11. Symptomatic AF and AT episodes >30 seconds on/off antiarrhythmic medication. 12. AF episodes > 6 minutes on/off antiarrhythmic medication. 13. Symptomatic AF episodes > 6 minutes on/off antiarrhythmic medication. 14. AT episodes of >6 minutes on/off antiarrhythmic medication. 15. Symptomatic AT episodes > 6 minutes on/off antiarrhythmic medication. 16. AF and AT episodes > 6 minutes on/off antiarrhythmic medication. 17. Symptomatic AF and AT episodes > 6 minutes on/off antiarrhythmic medication. 18. Procedure duration. 19. Fluoroscopy time and radiation dose. 20. Endocardial and epicardial radiofrequency ablation times. 21. Successful bidirectional linear block in Arms 2 and 3. 22. Bidirectional linear block requiring epicardial ablation in Arms 2 and 3. 23. Incidence of peri-procedural complications. 24. Quality of life measurements (EQ-5D and AFEQT). 25. Number of chemical | — |
Countries
Denmark, England, Scotland, Sweden, United Kingdom
Contacts
Public ContactJohn Silberbauer
Outcome results
None listed