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Topera E-FIRM Registry

NCT02386345 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 299

Last updated 2020-01-14

Study results available
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Summary

This is a registry to assess the safety and effectiveness of FIRM guided procedures for the treatment of symptomatic any type of atrial fibrillation.

FIRM (Focal Impulse and Rotor Modulation) guided ablation is defined as ablating rotors identified by the FIRMap® basket catheter for visualising of rotors with the RhythmView® mapping system. In addition to the FIRM guided ablation any other ablation method could be applied.The acute success of FIRM ablations is defined as elimination of rotors defined by absence of rotors.

Data items will be collected, if available, consistent and applicable with routine and standard clinical care at each participating site.

Conditions

Sponsors & Collaborators

  • I-Med-Pro GmbH

    collaborator OTHER

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Gerhard Hindricks, Prof. Dr. · Herzzentrum Leipzig - Universitätsklinik

  • Kristin Ruffner, PhD · Abbott

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-05-31
Completion
2018-07-31

Countries

  • Germany
  • Netherlands

Study Locations

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Entities

Diseases

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 NCT02386345 on ClinicalTrials.gov