Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Persistent atrial fibrillation, Atrial fibrillation ablation
Brief summary
Persistent atrial fibrillation (AF) is a common and distressing condition, that can cause significant symptoms. AF ablation is a recognised technique to treat persistent AF, but can be technically difficult. This study compares percutaneous ablation to thoracoscopic surgical AF ablation.
Interventions
PROCEDURESurgical AF ablation
Minimally invasive thoracoscopic surgical ablation of atrial fibrillation
PROCEDUREPercutaneous AF ablation
Percutaneous catheter ablation of atrial fibrillation
Sponsors
Neil Sulke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic persistent or long-standing AF suitable for AF ablation. * Age over 18 years old. * Informed consent to participate in this study.
Exclusion criteria
* Pre-existing ILRs or permanent pacemakers that do not allow for continuous monitoring for AF occurrence, or are not MRI-safe. * Unable to undergo general anaesthesia for AF ablation. * Previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery. * Scheduled for elective cardiac surgery, such as coronary artery bypass grafting or valvular surgery. * Previous thoracic surgery. * Participation in a conflicting study. * Potential participants who are mentally incapacitated and cannot consent or comply with follow-up * Pregnancy * Other cardiac rhythm disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of persistent AF by 12 months after ablation | 12 months | Mean time to recurrence of persistent AF after ablation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first episode of symptomatic AF after ablation | 12 months | Time to first episode of symptomatic AF after ablation |
| Time to first episode of any AF after ablation | 12 months | As detected by ILR |
| Total number of AF episodes after AF ablation | 12 months | As detected by ILR, outside blanking period |
| Total number of AF episodes lasting greater than 6 minutes after AF ablation | 12 months | As detected by ILR, outside blanking period |
| New MRI-detected subclinical cerebral embolic events | 3 months | — |
| Change in AF burden after AF ablation | 12 months | Detected by ILR |
Other
| Measure | Time frame |
|---|---|
| Change in echocardiographic left atrial dimensions and function after AF ablation | 12 months |
| Change in cognitive function as assessed by the Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) instruments | 12 months |
| Change in exercise capacity assessed by cardiopulmonary exercise testing (CPET) after AF ablation | 12 months |
| Quality of life changes after AF ablation | 12 months |
Countries
United Kingdom
Outcome results
None listed