Paroxysmal Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Ablation, Implantable loop recorder
Brief summary
This study is designed to compare three different techniques in ablation of paroxysmal atrial fibrillation. Namely, the Medtronic multi-electrode phased radiofrequency ablation system, the Biosense Webster irrigated multi-electrode phased radiofrequency ablation system, and minimally invasive thoracoscopic surgical ablation. The study hypothesis is that surgical and Biosense Webster ablation are non-inferior to Medtronic ablation.
Detailed description
A target of 75 participants will be randomised 1:1:1 to one of the three treatment arms. Each participant will have an implantable loop recorder (ILR) prior to ablation in order to assess AF burden. After ablation, each participant will be followed up for a year. The ILR will be used to assess reduction in AF burden.
Interventions
DEVICEILR insertion
Insertion of implantable loop recorder
PROCEDUREAF ablation
AF ablation
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 paroxysmal AF suitable for AF ablation * Age \> 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 |
|---|---|---|
| AF burden | 12 months after ablation | Total proportion of time spent in AF as assessed by ILR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to AF recurrence | Up to one year | Time to recurrence of any AF after ablation |
| Time to first symptomatic AF recurrence | Up to one year | Time to first symptomatic AF recurrence as assessed by ILR. |
| Change in QoL measures | 12 months after ablation | Change in Quality of Life measures assessed by questionnaire. |
Countries
United Kingdom
Outcome results
None listed