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TerminatedNCT03893331DISCOVERUpdated Nov 13, 2023

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

An observational study in Ablation of Arrhythmia's, sponsored by Acutus Medical. Terminated at 12 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-13.

Sponsored by Acutus Medical · Observational

Why this study was terminated
Sponsor no longer performing clinical studies. Will be only a manufacturing facility
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
479
Ages
18 Years and older
Sex
All
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Study summary

AcQMap Registry is an observational study

Read the 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.

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Conditions studied

  • Ablation of Arrhythmia's

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Keywords

  • Arrhythmia's
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In context

Arrhythmias, Cardiac

885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.

This study's enrollment of 479 is above the median of 200 across 414 observational studies indexed under Arrhythmias, Cardiac.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

Acutus Medical is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.).
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
479 participants (actual)
Target follow-up
3 Years
Patient registry
Yes

Interventions

  • DeviceAcQMap 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).

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What researchers measure

Primary outcomes

  1. Procedural Ablation Outcomes

    • 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

    Time frame: 12 hours

Secondary outcomes

  1. Long-term Outcome

    • 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).

    Time frame: 3 years

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Study locations

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

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03893331
Lead sponsor
Acutus Medical
Responsible party
Sponsor
First posted
Mar 28, 2019
Start date
Jun 13, 2019
Primary completion
Nov 8, 2023
Completion
Nov 8, 2023
Last update
Nov 13, 2023

Study contacts

Simon James, MD
principal investigator · James Cook University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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