CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 299 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02386345
NCT02386345N/ACompleted

EU Focal Impulse and Rotor Modulation Registry -Topera E-FIRM Registry-

Abbott Medical Devices·observational·Posted Mar 11, 2015·Updated Jan 14, 2020

In Brief

An observational study for Atrial Fibrillation. Completed, enrolled 299 participants across 9 sites in 2 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Netherlands
CollaboratorsI-Med-Pro GmbH

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 11, 2015
Enrollment StartMar 1, 2015
Primary CompletionMay 31, 2017
Study CompletionJul 31, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.3 years ago