Status:
UNKNOWN
Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study: The LAAPITUP 2 Study
Lead Sponsor:
Neil Sulke
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 We...
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. A...
Eligibility Criteria
Inclusion
- Symptomatic paroxysmal AF suitable for AF ablation
- Age \> 18 years old
- Informed consent to participate in this study.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2015
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01504451
Start Date
April 1 2012
End Date
May 1 2015
Last Update
June 26 2014
Active Locations (2)
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1
Eastbourne General Hospital
Eastbourne, E Sussex, United Kingdom, BN21 2UD
2
Royal Sussex County Hospital
Brighton, Sussex, United Kingdom, BN2 5BE