Topera E-FIRM Registry

Abbott Medical Devices299 enrolled

Overview

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.

Prospective and retrospective enrollment is possible.

Study Type

OBSERVATIONAL

Enrollment

299

Conditions

Atrial Fibrillation

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (9)

Städtisches Klinikum Karlsruhe GmbH

Karlsruhe, Baden-Würtemberg, Germany

Herz- und Gefäßklinik

Bad Neustadt an der Saale, Bavaria, Germany

Klinikum Coburg GmbH

Coburg, Bavaria, Germany

Kardiologische Gemeinschaftspraxis am Park Sanssouci

Outcomes

Primary Outcomes

Number of Participants With Acute Success

Acute Success was defined as the elimination (by ablation) of all identified rotors

Time frame: day of procedure

Number of Participants With 12-Month Success

Single procedure freedom from atrial fibrillation recurrence

Time frame: 12-months after index procedure

Number of Participants With Acute Safety Success

Acute safety success was defined as freedom from Serious Adverse Events at 7 days after index procedure

Time frame: 7 days after index procedure

Number of Participants With 12-Month Safety Success

Success was defined as freedom from Serious Adverse Events at 12-months after index procedure

Time frame: 12-months after index procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.