Persistent Atrial Fibrillation Ablation Trial

Neil Sulke2 sites in 1 country50 target enrollmentSeptember 2014

ConditionsAtrial Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Neil Sulke
Enrollment: 50
Locations: 2
Primary Endpoint: Recurrence of persistent AF by 12 months after ablation
Status: Suspended
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

September 2016

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Neil Sulke

Responsible Party

Sponsor Investigator

Principal Investigator

Neil Sulke

Principal Investigator

Eastbourne General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Recurrence of persistent AF by 12 months after ablation

Time Frame: 12 months

Mean time to recurrence of persistent AF after ablation

Secondary Outcomes

Time to first episode of symptomatic AF after ablation(12 months)
Time to first episode of any AF after ablation(12 months)
Total number of AF episodes after AF ablation(12 months)
Total number of AF episodes lasting greater than 6 minutes after AF ablation(12 months)
New MRI-detected subclinical cerebral embolic events(3 months)
Change in AF burden after AF ablation(12 months)