Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP
NCT ID: NCT01095770
Last Updated: 2010-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2010-04-30
2012-11-30
Brief Summary
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1. To compare the efficacy and complication rates of 2 widely used methods, conventional irrigation tip ablation catheter (LASSO) and Ablation Frontiers ablation technology, of AF ablation for PAF.
2. To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared to the 'gold standard' DDD pacemaker Holter.
3. To accurately evaluate, by continuous rhythm monitoring for 1 year, the efficacy of AF ablation therapy for PAF.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ablation Frontiers Ablation
This group will undergo AF ablation using Ablation Frontiers Technology.
AF Ablation with Ablation Frontiers Technology
AF Ablation with Ablation Frontiers Technology - PVAC, TVAC and MASC.
LASSO ablation
This group will undergo atrial fibrillation ablation with traditional LASSO technology
AF Ablation with LASSO catheter
AF Ablation with traditional LASSO catheter
Reveal XT monitoring
This group will be monitored pre and post ablation using a Reveal XT implantable loop recorder.
Reveal XT
Reveal XT implantable loop recorder monitored group
Permanent Pacemaker - dual chamber
This group will be monitored pre and post ablation with a dual chamber permanent pacemaker
Permanent Dual Chamber Pacemaker
This group will be monitored with a dual chamber pacemaker with advanced AF monitoring capabilities.
Interventions
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AF Ablation with Ablation Frontiers Technology
AF Ablation with Ablation Frontiers Technology - PVAC, TVAC and MASC.
AF Ablation with LASSO catheter
AF Ablation with traditional LASSO catheter
Reveal XT
Reveal XT implantable loop recorder monitored group
Permanent Dual Chamber Pacemaker
This group will be monitored with a dual chamber pacemaker with advanced AF monitoring capabilities.
Eligibility Criteria
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Inclusion Criteria
* Symptomatic PAF with AF episodes self terminating after at least 30 seconds but not longer than 24 hours. Preference is given to patients with AF episodes lasting no longer than 4 hours.
* PAF should have failed at least one drug therapy medical therapy.
* Patients must give written informed consent form prior to participating in this study.
Exclusion Criteria
* Patient has had a myocardial infarction within last 2 months.
* Patient is expecting or has had major cardiac surgery within last 2 months.
* Patient is participating in a conflicting study.
* Patient is mentally incapacitated and cannot consent or comply with follow-up.
* Patient has NYHA class III/ IV heart failure.
* Patients with severe valvular or ventricular dysfunction.
* Pregnancy.
* Patient suffers with other cardiac rhythm disorders.
* Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings)
16 Years
80 Years
ALL
No
Sponsors
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Eastbourne General Hospital
OTHER
Responsible Party
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East Sussex NHS Trust
Principal Investigators
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Stephen S Furniss, FRCP, MD
Role: PRINCIPAL_INVESTIGATOR
East Sussex NHS Trust
AN Sulke, FRCP, MD
Role: PRINCIPAL_INVESTIGATOR
East Sussex NHS Trust
Locations
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Eastbourne District General Hospital
Eastbourne, East Sussex, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Steven J Podd, MBBS, MA, MRCP
Role: primary
References
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Podd SJ, Sulke AN, Sugihara C, Furniss SS. Phased multipolar radiofrequency pulmonary vein isolation is as effective and safe as conventional irrigated point-to-point ablation. A prospective randomised 1-year implantable cardiac monitoring device follow-up trial. J Interv Card Electrophysiol. 2015 Dec;44(3):257-64. doi: 10.1007/s10840-015-0042-0. Epub 2015 Aug 27.
Other Identifiers
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LAAPITUP
Identifier Type: -
Identifier Source: org_study_id