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Clinical Trials/NCT01891825
NCT01891825SuspendedNot Applicable

Persistent Atrial Fibrillation Ablation Trial

Neil Sulke4 sites in 1 country50 target enrollmentStarted: September 1, 2014Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Suspended
Sponsor
Enrollment
50
Locations
4
Primary Endpoint
Recurrence of persistent AF by 12 months after ablation
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

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)

Investigators

Sponsor
Neil Sulke
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Neil Sulke

Principal Investigator

Eastbourne General Hospital

Study Sites (4)

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