Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation
NCT ID: NCT02825992
Last Updated: 2020-06-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
129 participants
INTERVENTIONAL
2016-10-17
2018-05-15
Brief Summary
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A prospective, single-arm, multi-center, multi-national non-randomized study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-001 - Canadian)
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Detailed Description
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A prospective, single-arm, multi-center, multi-national non-randomized study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-001 - Canadian)
The research study was conducted in the EU and Canada. The protocol and the corresponding NCT number is as follows:
NCT02462980 (Protocol CL-AF-001, Site Ontario, Canada Dr. Verma = PI)
The above record was combined into one as both protocols are essentially identical (one is post market \[EU\] and the other pre-market \[Canada\] and one study report will be written that encompasses the data/results for both protocols.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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AcQMap System
All patients who underwent catheter ablation using the AcQMap System
AcQMap System
3D imaging and mapping system for cardiac chambers
Interventions
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AcQMap System
3D imaging and mapping system for cardiac chambers
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous AF ablation
* Significant structural heart disease
* Previous cerebral infarct
* Major bleeding disorders
* Pregnant or lactating
18 Years
80 Years
ALL
No
Sponsors
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Acutus Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Stephan Willems, MD
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf (UKE)
Locations
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Southlake Regional Health Center
Newmarket, Ontario, Canada
Na Homolce Hospital
Prague, , Czechia
Vivantes Klinikum Am Urban
Berlin, , Germany
Herzzentrum der Universität zu Köln
Cologne, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Centro Cardiologico Monzino
Milan, , Italy
Maastricht University Medical Center
Maastricht, , Netherlands
St. Antonius Hospital
Nieuwegein, , Netherlands
Freeman Hospital
Newcastle, Newcastle Upon Tyne, United Kingdom
Papworth Hospital
Cambridge, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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References
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Willems S, Verma A, Betts TR, Murray S, Neuzil P, Ince H, Steven D, Sultan A, Heck PM, Hall MC, Tondo C, Pison L, Wong T, Boersma LV, Meyer C, Grace A. Targeting Nonpulmonary Vein Sources in Persistent Atrial Fibrillation Identified by Noncontact Charge Density Mapping: UNCOVER AF Trial. Circ Arrhythm Electrophysiol. 2019 Jul;12(7):e007233. doi: 10.1161/CIRCEP.119.007233. Epub 2019 Jun 27.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CL-AF-001
Identifier Type: OTHER
Identifier Source: secondary_id
CL-AF-002
Identifier Type: -
Identifier Source: org_study_id
NCT02462980
Identifier Type: -
Identifier Source: nct_alias
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