Randomized Trial of Two Ablation Catheters in Paroxysmal Atrial Fibrillation
NCT ID: NCT00678340
Last Updated: 2013-03-06
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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COMPLETED
PHASE4
178 participants
INTERVENTIONAL
2007-09-30
2013-03-31
Brief Summary
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Ablation is a procedure performed with small tubes (catheters) that are introduced through the top of the leg. Burns are made inside of the heart to treat AF. This procedure has been shown to cure 90% of patients with intermittent (paroxysmal) AF.
The investigators currently use either one of two different catheters to create these burns inside the heart. The investigators do not know which is the best catheter to use in patients with paroxysmal atrial fibrillation.
The investigators study will randomly allocate patients to have their ablation performed by either one of the catheters to give a fair comparison between the two. The investigators objective is to study the differences between these two catheters.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
WACA and PVI
WACA and PVI
Wide area circumferential ablation (WACA) in the pulmonary vein antrum with subsequent pulmonary vein isolation (PVI) with a single tip irrigated catheter.
2
PVAC
PVAC
Circumferential ablation with a circular ablation catheter (Ablation Frontiers) to electrical silence.
Interventions
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WACA and PVI
Wide area circumferential ablation (WACA) in the pulmonary vein antrum with subsequent pulmonary vein isolation (PVI) with a single tip irrigated catheter.
PVAC
Circumferential ablation with a circular ablation catheter (Ablation Frontiers) to electrical silence.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* LA size greater than 60mm
* Mechanical prosthetic MVR
* Hypertrophic cardiomyopathy
18 Years
ALL
No
Sponsors
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University Hospital Southampton NHS Foundation Trust
OTHER
The Royal Bournemouth Hospital
OTHER
Pier Lambiase
OTHER
Responsible Party
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Pier Lambiase
Chief Investigator
Principal Investigators
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Pier D Lambiase, PhD
Role: PRINCIPAL_INVESTIGATOR
University College Hospital London NHS Foundation Trust
Locations
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University College Hospital London NHS Foundation Trust
London, , United Kingdom
Countries
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References
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McCready J, Chow AW, Lowe MD, Segal OR, Ahsan S, de Bono J, Dhaliwal M, Mfuko C, Ng A, Rowland ER, Bradley RJ, Paisey J, Roberts P, Morgan JM, Sandilands A, Yue A, Lambiase PD. Safety and efficacy of multipolar pulmonary vein ablation catheter vs. irrigated radiofrequency ablation for paroxysmal atrial fibrillation: a randomized multicentre trial. Europace. 2014 Aug;16(8):1145-53. doi: 10.1093/europace/euu064. Epub 2014 May 19.
Other Identifiers
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UCH 07/0094
Identifier Type: -
Identifier Source: org_study_id
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