Efficacy and Safety Study on Agilis NxT Introducer in AF Patients
NCT ID: NCT00469638
Last Updated: 2019-02-04
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
NA
130 participants
INTERVENTIONAL
2007-05-31
2010-04-30
Brief Summary
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Detailed Description
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Primary Endpoint: rate of patients in stable sinus rhythm at 6 Month Follow Up
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Agilis sheeth group
Left atrial catheter ablation guided by introducer using Agilis sheeth
Left atrial catheter ablation guided by introducer using Agilis sheeth
Non-steerable sheeth group
Left atrial catheter ablation guided by introducer using Non-steerable sheeth
Left atrial catheter ablation guided by introducer using Non-steerable sheeth
Interventions
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Left atrial catheter ablation guided by introducer using Agilis sheeth
Left atrial catheter ablation guided by introducer using Agilis sheeth
Left atrial catheter ablation guided by introducer using Non-steerable sheeth
Left atrial catheter ablation guided by introducer using Non-steerable sheeth
Eligibility Criteria
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Inclusion Criteria
* Resistant to at least 1 anti arrhythmic drug
* Left atrial diameter less then 60 mm (TTE, parasternal)
* Atrial fibrillation documented by ECG
* Patient is willing and available to perform all Follow Ups
Exclusion Criteria
* Pre existing left atrial fibrillation ablation
* Atrial fibrillation due to reversible cause
* Known intracardiac or other thrombi
* Pregnancy
* Women of child bearing potential without negative pregnancy test within 48 hours prior to ablation
* Contraindication for anticoagulation
18 Years
75 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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St Jude Medical Germany, GMBH
Principal Investigators
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Gerhard Hindricks, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Herzzentrum Leipzig, Abteilung für Rhythmologie, Strümpellstraße 39, 04289 Leipzig, Germany
Locations
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Herzzenturm Leipzig
Leipzig, , Germany
Countries
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References
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Piorkowski C, Eitel C, Rolf S, Bode K, Sommer P, Gaspar T, Kircher S, Wetzel U, Parwani AS, Boldt LH, Mende M, Bollmann A, Husser D, Dagres N, Esato M, Arya A, Haverkamp W, Hindricks G. Steerable versus nonsteerable sheath technology in atrial fibrillation ablation: a prospective, randomized study. Circ Arrhythm Electrophysiol. 2011 Apr;4(2):157-65. doi: 10.1161/CIRCEP.110.957761. Epub 2011 Jan 19.
Kannel WB, Abbott RD, Savage DD, McNamara PM. Epidemiologic features of chronic atrial fibrillation: the Framingham study. N Engl J Med. 1982 Apr 29;306(17):1018-22. doi: 10.1056/NEJM198204293061703.
Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991 Aug;22(8):983-8. doi: 10.1161/01.str.22.8.983.
Piorkowski C, Hindricks G, Weiss S et al: Long term outcome of circumferential left atrial PV ablation using a steerable transseptal sheath. Poster European Society of Cardiology 2006, Barcelona
Other Identifiers
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A07
Identifier Type: -
Identifier Source: org_study_id
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