Topera E-FIRM Registry

Abbott

Status: Completed

Conditions: Atrial Fibrillation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02386345

E-FIRM 02

Details and patient eligibility

About

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.

Full description

Prospective and retrospective enrollment is possible.

Enrollment: 299 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design