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AcQMap Objectively Visualize the Etiology of Recurrent AF Following a Failed AF Ablation

NCT03368781 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2022-07-27

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 AcQMap High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure. (CLP-AF-004 \[EU\])

A prospective, single-arm, multi-center, non-randomized, pre-market study designed to provide clinical data regarding the use of the AcQMap High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure. (CLP-AF-005 \[Canada\])

Conditions

  • Recurrent Atrial Fibrillation

Interventions

DEVICE

AcQMap Imaging and Mapping System

3D Cardiac Imaging and Mapping during ablation procedures

Sponsors & Collaborators

  • Acutus Medical

    lead INDUSTRY

Principal Investigators

  • Andrew Grace, MD · Papworth Hospital NHS

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-12
Primary Completion
2020-10-29
Completion
2020-10-29
FDA Device
Yes

Countries

  • Belgium
  • Canada
  • Czechia
  • Germany
  • 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 NCT03368781 on ClinicalTrials.gov