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Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation (UNCOVER-AF)

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ClinicalTrials.gov Identifier: NCT02825992
Recruitment Status : Completed
First Posted : July 7, 2016
Results First Posted : June 5, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Acutus Medical

Brief Summary:

A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-002 - EU)

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)


Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Device: AcQMap System Not Applicable

Detailed Description:

A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-002 - EU)

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation (UNCOVER-AF)
Actual Study Start Date : October 17, 2016
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
AcQMap System
All patients who underwent catheter ablation using the AcQMap System
Device: AcQMap System
3D imaging and mapping system for cardiac chambers




Primary Outcome Measures :
  1. Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs) [ Time Frame: 24 hours ]
    MAEs include: Death, cardiac perforation, cerebral infarct, systemic embolism, major bleeding, cardiac valve damage.


Secondary Outcome Measures :
  1. Number of Participants Who Experienced at Least One Adverse Events. [ Time Frame: 12 Months ]
    Recording of all adverse events through 12 month follow-up

  2. Number of Participants Who Were in Sinus Rhythm Following the Ablation Procedure. [ Time Frame: 24 hours ]
    Conversion to sinus rhythm post ablation

  3. Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation. [ Time Frame: 6, 9, and 12 Months ]
    Freedom from AF



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for an ablation of persistent atrial fibrillation

Exclusion Criteria:

  • Any duration of continuous AF lasting longer than 12 months
  • Previous AF ablation
  • Significant structural heart disease
  • Previous cerebral infarct
  • Major bleeding disorders
  • Pregnant or lactating

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825992


Locations
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Canada, Ontario
Southlake Regional Health Center
Newmarket, Ontario, Canada, L3Y 2P9
Czechia
Na Homolce Hospital
Prague, Czechia, 150 30
Germany
Vivantes Klinikum Am Urban
Berlin, Germany, 10967
Herzzentrum der Universität zu Köln
Cologne, Germany, D-50937
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Italy
Centro Cardiologico Monzino
Milano, Italy, 20100
Netherlands
Maastricht University Medical Center
Maastricht, Netherlands, 6229 HX
St. Antonius Hospital
Nieuwegein, Netherlands, 3435 CM
United Kingdom
Freeman Hospital
Newcastle, Newcastle Upon Tyne, United Kingdom, NE7 7DN
Papworth Hospital
Cambridge, United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
Acutus Medical
Investigators
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Principal Investigator: Stephan Willems, MD Universitätsklinikum Hamburg-Eppendorf (UKE)
  Study Documents (Full-Text)

Documents provided by Acutus Medical:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Acutus Medical
ClinicalTrials.gov Identifier: NCT02825992    
Obsolete Identifiers: NCT02462980
Other Study ID Numbers: CL-AF-002
CL-AF-001 ( Other Identifier: Acutus Medical )
First Posted: July 7, 2016    Key Record Dates
Results First Posted: June 5, 2020
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes