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

NCT ID: NCT03893331

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

479 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-13

Study Completion Date

2023-11-08

Brief Summary

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AcQMap Registry is an observational study

Detailed Description

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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.

Conditions

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Ablation of Arrhythmia's

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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.).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acutus Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simon James, MD

Role: PRINCIPAL_INVESTIGATOR

James Cook University Hospital

Locations

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I.C.P.S. Hôspital Privé Jacques Cartier

Paris, , France

Site Status

Klinikum Coburg

Coburg, , Germany

Site Status

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

Site Status

Erasmus MC Cardiologie Elektrofysiologie

Rotterdam, , Netherlands

Site Status

Papworth Hospital NHS Foundation Trust

Cambridge, , United Kingdom

Site Status

Royal Brompton Hospital

London, , United Kingdom

Site Status

St. George's Hospital

London, , United Kingdom

Site Status

James Cook University Hospital

Middlesbrough, , United Kingdom

Site Status

Freeman Hospital

Newcastle upon Tyne, , United Kingdom

Site Status

Norfolk and Norwich University Hospital

Norwich, , United Kingdom

Site Status

John Radcliffe Hospital

Oxford, , United Kingdom

Site Status

Sheffield Teaching Hospital Northern General Hospital

Sheffield, , United Kingdom

Site Status

Countries

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France Germany Netherlands United Kingdom

Other Identifiers

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CLP-AF-006

Identifier Type: -

Identifier Source: org_study_id

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