Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study 2
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Paroxysmal Atrial Fibrillation
- Sponsor
- Neil Sulke
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- AF burden
- Last Updated
- 11 years ago
Overview
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.
Investigators
Neil Sulke
Consultant Cardiologist
Eastbourne General Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
AF burden
Time Frame: 12 months after ablation
Total proportion of time spent in AF as assessed by ILR
Secondary Outcomes
- Time to AF recurrence(Up to one year)
- Time to first symptomatic AF recurrence(Up to one year)
- Change in QoL measures(12 months after ablation)