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Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation

NCT02825992 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2020-06-05

Study results available
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Summary

A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study designed to provide clinical data regarding the use of the AcQMapâ„¢ System in the ablation of persistent atrial fibrillation. (CL-AF-002 - EU)

A prospective, single-arm, multi-center, multi-national non-randomized study designed to provide clinical data regarding the use of the AcQMapâ„¢ System in the ablation of persistent atrial fibrillation. (CL-AF-001 - Canadian)

Conditions

  • Persistent Atrial Fibrillation

Interventions

DEVICE

AcQMap System

3D imaging and mapping system for cardiac chambers

Sponsors & Collaborators

  • Acutus Medical

    lead INDUSTRY

Principal Investigators

  • Stephan Willems, MD · Universitätsklinikum Hamburg-Eppendorf (UKE)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-17
Primary Completion
2017-04-30
Completion
2018-05-15

Countries

  • Canada
  • Czechia
  • Germany
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02825992 on ClinicalTrials.gov