AcQMap Objectively Visualize the Etiology of Recurrent AF Following a Failed AF Ablation
NCT ID: NCT03368781
Last Updated: 2022-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
128 participants
INTERVENTIONAL
2018-04-12
2020-10-29
Brief Summary
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A prospective, single-arm, multi-center, non-randomized, pre-market study designed to provide clinical data regarding the use of the AcQMap High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure. (CLP-AF-005 \[Canada\])
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Detailed Description
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A prospective, single-arm, multi-center, multi-national, non-randomized, pre-market study designed to provide clinical data regarding the use of the AcQMap High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure. The patient population includes men and women, eighteen (18) years of age or older. The treatment plan must include evaluation and ablation (as indicated) of pulmonary vein reconnections plus AcQMap guided non-PV substrate ablation. Subject assessments will occur at screening, procedure, hospital discharge, 3-, 6-, and 12-months. (CLP-AF-005 \[Canada\])
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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AcQMap Imaging and Mapping
Use of the AcQMap Imaging and Mapping System as a diagnostic modality in an ablation retreatment procedure for recurrent atrial fibrillation following a failed AF ablation.
AcQMap Imaging and Mapping System
3D Cardiac Imaging and Mapping during ablation procedures
Interventions
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AcQMap Imaging and Mapping System
3D Cardiac Imaging and Mapping during ablation procedures
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently scheduled for a repeat endocardial ablation of AF where the index atrial fibrillation ablation procedure was completed ≤ twenty-four (24) months prior to enrollment and the subject has demonstrated at least one episode of post-ablation non-self-terminating AF
Exclusion Criteria
* Structural heart disease or implanted cardiac devices
* History of blood clotting or bleeding disease
* Pregnant or lactating (current or anticipated during study follow up)
* Evidence of left atrial thrombus
18 Years
ALL
No
Sponsors
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Acutus Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew Grace, MD
Role: PRINCIPAL_INVESTIGATOR
Papworth Hospital NHS
Locations
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UZ Brussel Centrum voor Hart-en Vaatziekten
Belsele, Jette, Belgium
Southlake Regional Health Center
Newmarket, Ontario, Canada
Na Homolce Hospital
Prague, , Czechia
Klinikum Coburg
Coburg, , Germany
Klinikum Coburg
Coburg, , Germany
Herzzentrum der Universität zu Köln
Cologne, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
St. Antonius Hospital
Nieuwegein, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Papworth Hospital NHS
Cambridge, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Sheffield Teaching Hospital Northern
Sheffield, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CLP-AF-005
Identifier Type: OTHER
Identifier Source: secondary_id
CLP-AF-004-NL
Identifier Type: OTHER
Identifier Source: secondary_id
CLP-AF-004
Identifier Type: -
Identifier Source: org_study_id
NCT03467126
Identifier Type: -
Identifier Source: nct_alias
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