Catheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation
NCT ID: NCT01037296
Last Updated: 2014-07-10
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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TERMINATED
PHASE4
166 participants
INTERVENTIONAL
2008-04-30
2013-09-30
Brief Summary
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Substudy: Platelet reactivity and activation in AF, and the impact of curative ablation. Blood and urine samples will be taken pre- and 3 months post ablation to see if platelet reactivity and activation are affected by AF compared to established normal ranges, and whether curative ablation impacts on this.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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manual ablation
catheter ablation
Ablation will be performed as normal treatment
robotic ablation
catheter ablation
ablation procedure performed with Hansen robotic navigation system
Interventions
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catheter ablation
ablation procedure performed with Hansen robotic navigation system
catheter ablation
Ablation will be performed as normal treatment
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous ablation procedure
* Expected life expectancy \< 6 months
* Inability or unwillingness to sign consent
* Pregnancy
* Contraindications for the ablation procedure o Thrombus in the left atrium that fails to resolve with optimal oral anticoagulation therapy
18 Years
ALL
No
Sponsors
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Barts & The London NHS Trust
OTHER
Responsible Party
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Locations
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Barts and the London NHS Trust
London, London, United Kingdom
Countries
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References
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Ullah W, McLean A, Hunter RJ, Baker V, Richmond L, Cantor EJ, Dhinoja MB, Sporton S, Earley MJ, Schilling RJ. Randomized trial comparing robotic to manual ablation for atrial fibrillation. Heart Rhythm. 2014 Nov;11(11):1862-9. doi: 10.1016/j.hrthm.2014.06.026. Epub 2014 Jun 21.
Duncan ER, Finlay M, Page SP, Hunter R, Goromonzi F, Richmond L, Baker V, Ginks M, Ezzat V, Dhinoja M, Earley MJ, Sporton S, Schilling RJ. Improved electrogram attenuation during ablation of paroxysmal atrial fibrillation with the Hansen robotic system. Pacing Clin Electrophysiol. 2012 Jun;35(6):730-8. doi: 10.1111/j.1540-8159.2012.03381.x. Epub 2012 Apr 11.
Other Identifiers
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005815
Identifier Type: -
Identifier Source: org_study_id
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