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AcQMap® Global Registry of Procedural and Long-term Clinical Outcomes (AcQMap Registry) (DISCOVER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03893331
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : October 13, 2021
Sponsor:
Information provided by (Responsible Party):
Acutus Medical

Study Description
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Brief Summary:
AcQMap Registry is an observational study

Condition or disease Intervention/treatment
Ablation of Arrhythmia's Device: AcQMap System

Detailed Description:
AcQMap Registry is an observational, prospective, multi-center, multi-national, open-label registry designed to provide clinical data regarding the commercial, real-life experience with the diagnostic AcQMap System.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: AcQMap® Global Registry of Procedural and Long-term Clinical Outcomes (AcQMap Registry)
Actual Study Start Date : June 13, 2019
Estimated Primary Completion Date : August 15, 2024
Estimated Study Completion Date : February 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Groups and Cohorts
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Intervention Details:
  • Device: AcQMap System
    To evaluate procedural and long-term outcomes when using the diagnostic AcQMap System as an imaging and mapping system for ablation of arrhythmias in accordance with the Instructions for Use (IFU).

Outcome Measures
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Primary Outcome Measures :
  1. Procedural Ablation Outcomes [ Time Frame: 12 hours ]
    • Number of participants who had termination of ablated arrhythmia's to Sinus Rhythm within 12 hours post ablation procedure with or without electrical or pharmacological cardioversion


Secondary Outcome Measures :
  1. Long-term Outcome [ Time Frame: 3 years ]
    • First-procedure freedom from any arrhythmia on and/or off AADs, throughout the follow-up period, excluding events in the initial 90 days following the procedure (blanking period).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Any participant 18 years of age or older. Currently scheduled for an ablation of an arrhythmia utilizing the diagnostic AcQMap System.
Criteria

Inclusion Criteria:

  • Male or female 18 years of age or older.
  • Currently scheduled for an ablation of an arrhythmia utilizing the diagnostic AcQMap System.
  • Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.
  • Willing and able to give written informed consent.

Exclusion Criteria:

  • In the opinion of the Investigator, any known contraindications to an ablation procedure.
  • Current enrollment in any study protocol sponsored by Acutus Medical.
  • Any other condition that, in the judgment of the investigator, makes the participant a poor candidate for this procedure, the study, or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, extensive travel away from the research center, etc.).
Contacts and Locations
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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): NCT03893331


Contacts
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Contact: Steve McQuillan 7633314344 steven.mcquillan@acutus.com
Contact: Deana Pierce 4422326087 deana.pierce@acutus.com

Locations
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Netherlands
St. Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands, 3435
Contact: Lucas Boersma, MD       l.boersma@antoniusziekenhuis.nl   
Contact: Michael Bosschaert, MD       m.bosschaert@antoniusziekenhuis.nl   
Principal Investigator: Lucas Boersma, MD         
Erasmus MC Cardiologie Elektrofysiologie Recruiting
Rotterdam, Netherlands, 3015 CE
Contact: Tamas Szili-Torok, MD       t.szilitorok@erasmusmc.nl   
Contact: Petter Janse    +31 10 703 2700    p.janse@erasmusmc.nl   
Principal Investigator: Tamas Szili-Torok, MD         
United Kingdom
Papworth Hospital NHS Foundation Trust Recruiting
Cambridge, United Kingdom, CB38RE
Contact: Andrew Grace, MD    44 1223 333 631    aag1000@cam.ac.uk   
Contact: Rebecca McClean    44 1480 364 787    Rebecca.McClean@papworth.nhs.uk   
Principal Investigator: Andrew Grace, MD         
Royal Brompton Hospital Recruiting
London, United Kingdom, SW3 6NP
Contact: Tom Wong, MD       tom.wong@ic.ac.uk   
Contact: Debra Dempster       d.dempster@rbht.nhs.uk   
Principal Investigator: Tom Wong, MD         
James Cook University Hospital Recruiting
Middlesbrough, United Kingdom, TS4 3BW
Contact: Simon James, MD    01642 282410    simon.james1@nhs.net   
Contact: Deborah Athorne    01642 282410    deborah.athorne@nhs.net   
Principal Investigator: Simon James, MD         
Freeman Hospital Recruiting
Newcastle upon Tyne, United Kingdom, NE7 7DN
Contact: Ewen Shepherd, MD    7606379109    ewen.shepherd@nuth.nhs.uk   
Contact: Ursula Harrison    44 191 213 7743    Ursula.Harrison@nuth.nhs.uk   
Principal Investigator: Ewen Shepherd, MD         
John Radcliffe Hospital Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Tim Betts, MD    49 40 7410 52438    tim.betts@ouh.nhs.uk   
Contact: Amy Hartley    44 1865 223 173    Amy.hartley@ouh.nhs.uk   
Principal Investigator: Tim Betts, MD         
Sheffield Teaching Hospital Northern General Hospital Recruiting
Sheffield, United Kingdom, S57AU
Contact: Justin Lee, MD       Justin.lee@sth.nhs.uk   
Contact: Charlotte Culver       charlotte.culver@sth.nhs.uk   
Principal Investigator: Justin Lee, MD         
Sponsors and Collaborators
Acutus Medical
Investigators
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Principal Investigator: Simon James, MD James Cook University Hospital
More Information
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Additional Information:

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Responsible Party: Acutus Medical
ClinicalTrials.gov Identifier: NCT03893331    
Other Study ID Numbers: CLP-AF-006
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: October 13, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Acutus Medical:
Arrhythmia's
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes