N/A Completed N=299

Topera E-FIRM Registry

Atrial Fibrillation

Source: ClinicalTrials.gov NCT02386345 ↗

Enrolled (actual)

299

Serious AEs

11.4%

Results posted

Oct 2019

Primary outcomePrimary: Number of Participants With Acute Success — 165 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Acute Success	165	—
PRIMARY Number of Participants With 12-Month Success	101	—
PRIMARY Number of Participants With Acute Safety Success	257	—
PRIMARY Number of Participants With 12-Month Safety Success	184	—

Eligibility Criteria

Inclusion Criteria

reported incidence of at least 2 documented episodes of symptomatic AF (paroxysmal, persistent or long standing persistent) during the 3 months preceding the initial AF ablation attempt of at least one Class I or III anti-arrhythmia drug with failure defined as recurrence of symptomatic AF or adverse drug effect resulting in stopping medication

Exclusion Criteria

women who are pregnant

As this is a registry only data of patients will be included who have been treated according to the current AF guidelines.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02386345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.