Topera E-FIRM Registry

NCT ID: NCT02386345

Last Updated: 2020-01-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

299 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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Prospective and retrospective enrollment is possible.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I-Med-Pro GmbH

OTHER

Sponsor Role collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gerhard Hindricks, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Herzzentrum Leipzig - Universitätsklinik

Kristin Ruffner, PhD

Role: STUDY_DIRECTOR

Abbott

Locations

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Städtisches Klinikum Karlsruhe GmbH

Karlsruhe, Baden-Würtemberg, Germany

Site Status

Herz- und Gefäßklinik

Bad Neustadt an der Saale, Bavaria, Germany

Site Status

Klinikum Coburg GmbH

Coburg, Bavaria, Germany

Site Status

Kardiologische Gemeinschaftspraxis am Park Sanssouci

Potsdam, Brandenburg, Germany

Site Status

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, North Rhine-Westphalia, Germany

Site Status

Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR

Dresden, Saxony, Germany

Site Status

Herzzentrum Leipzig

Leipzig, Saxony, Germany

Site Status

Unfallkrankenhaus Berlin

Berlin, , Germany

Site Status

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

Countries

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Germany Netherlands

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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E-FIRM 02

Identifier Type: -

Identifier Source: org_study_id

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