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AcQMap® US Registry of Procedural and Long-term Clinical Outcomes (Discover-US)

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: NCT04431544
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : March 10, 2022
Information provided by (Responsible Party):
Acutus Medical

Brief Summary:
AcQMap Registry is an observation study

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

Detailed Description:
AcQMap Registry is an observational, prospective, multi-center, open-label registry designed to provide clinical data regarding the commercial, real-life experience with the diagnostic AcQMap System.

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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® US Registry of Procedural and Long-term Clinical Outcomes (Discover-US)
Actual Study Start Date : September 29, 2020
Estimated Primary Completion Date : October 1, 2025
Estimated Study Completion Date : November 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

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).

Primary Outcome Measures :
  1. Procedural Ablation Outcomes [ Time Frame: 12 hours ]
    Number of participants who had termination of ablated arrhythmia's to Sinus Rhythm or another arrhythmia 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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
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.

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.).

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): NCT04431544

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Contact: Jerald Cox, PA 7605296310 jerry.cox@acutus.com
Contact: Deana Pierce 4422326087 deana.pierce@acutus.com

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Sponsors and Collaborators
Acutus Medical
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Responsible Party: Acutus Medical
ClinicalTrials.gov Identifier: NCT04431544    
Other Study ID Numbers: CLP-20
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: March 2022
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Acutus Medical:
atrial arrhythmia
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes