Persistent Atrial Fibrillation Ablation Trial

Not Applicable

Suspended

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Percutaneous AF ablation; Procedure: Surgical AF ablation

• Registration Number: NCT01891825
• Lead Sponsor: Neil Sulke

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-29
• Study First Submitted QC: 2013-06-29
• Study First Posted: 2013-07-03
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-25
• Last Update Posted: 2014-06-26
• Study Start: 2014-09
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pecutaneous AF ablation	Percutaneous AF ablation	Percutaneous catheter ablation of atrial fibrillation
Surgical AF ablation	Surgical AF ablation	Minimally invasive thoracoscopic surgical ablation of atrial fibrillation

Primary Outcome Measures

Name	Time	Method
Recurrence of persistent AF by 12 months after ablation	12 months	Mean time to recurrence of persistent AF after ablation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Royal Sussex County Hospital; 🇬🇧 Brighton, East Sussex, United Kingdom

Eastbourne General Hospital; 🇬🇧 Eastbourne, E Sussex, United Kingdom