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

November 9, 2023 updated by: Acutus Medical
AcQMap Registry is an observational study

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

479

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • I.C.P.S. Hôspital Privé Jacques Cartier
  • Germany
      • Coburg, Germany
        • Klinikum Coburg
  • Netherlands
      • Nieuwegein, Netherlands, 3435
        • St. Antonius Ziekenhuis
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus MC Cardiologie Elektrofysiologie
  • United Kingdom
      • Cambridge, United Kingdom, CB38RE
        • Papworth Hospital NHS Foundation Trust
      • London, United Kingdom, SW3 6NP
        • Royal Brompton Hospital
      • London, United Kingdom
        • St. George's Hospital
      • Middlesbrough, United Kingdom, TS4 3BW
        • James Cook University Hospital
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital
      • Norwich, United Kingdom
        • Norfolk and Norwich University Hospital
      • Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
      • Sheffield, United Kingdom, S57AU
        • Sheffield Teaching Hospital Northern General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acutus Medical

Investigators

  • Principal Investigator: Simon James, MD, James Cook University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2019

Primary Completion (Actual)

November 8, 2023

Study Completion (Actual)

November 8, 2023

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

March 26, 2019

First Posted (Actual)

March 28, 2019

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP-AF-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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