Topera E-FIRM Registry

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386345
• Other study ID #: E-FIRM 02
• Status: Completed
• Start date: March 2015
• Est. completion date: July 31, 2018

Study information

• Verified date: January 2020
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Prospective and retrospective enrollment is possible.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: July 31, 2018
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Germany	Herz- und Gefäßklinik	Bad Neustadt An Der Saale	Bayern
Germany	Herz- und Diabeteszentrum NRW	Bad Oeynhausen	NRW
Germany	Unfallkrankenhaus Berlin	Berlin
Germany	Klinikum Coburg GmbH	Coburg	Bayern
Germany	Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR	Dresden	Sachsen
Germany	Städtisches Klinikum Karlsruhe GmbH	Karlsruhe	Baden-Würtemberg
Germany	Herzzentrum Leipzig	Leipzig	Sachsen
Germany	Kardiologische Gemeinschaftspraxis am Park Sanssouci	Potsdam	Brandenburg
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Medical Devices	I-Med-Pro GmbH

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With 6-Month Safety Success	Success was defined as freedom from Serious Adverse Events at 6-months after index procedure	6-months after index procedure
Primary	Number of Participants With Acute Success	Acute Success was defined as the elimination (by ablation) of all identified rotors	day of procedure
Primary	Number of Participants With 12-Month Success	Single procedure freedom from atrial fibrillation recurrence	12-months after index procedure
Primary	Number of Participants With Acute Safety Success	Acute safety success was defined as freedom from Serious Adverse Events at 7 days after index procedure	7 days after index procedure
Primary	Number of Participants With 12-Month Safety Success	Success was defined as freedom from Serious Adverse Events at 12-months after index procedure	12-months after index procedure