Topera C-FIRM Registry

Control for EU (European Union) Focal Impulse and Rotor Modulation Registry - Topera C-FIRM Registry-

This is a control registry to the E-FIRM registry to track conventional atrial fibrillation (AF) procedures in terms of clinical usage, handling, and the safety and effectiveness for the treatment of symptomatic atrial fibrillation. Conventional AF ablation is defined as pulmonary vein isolation (PVI) and any additional ablation for AF according to the standard routine of the center.

Data items will be collected, if available, consistent and applicable with routine and standard clinical care at each participating site.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation

Detailed Description

Prospective and retrospective enrollment possible

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12683
    • Unfallkrankenhaus Berlin
  • Baden-Würtemberg
    • Karlsruhe, Baden-Würtemberg, Germany, 76133
      • Städtisches Klinikum Karlsruhe GmbH
  • Bayern
    • Bad Neustadt An Der Saale, Bayern, Germany, 97616
      • Herz- und Gefäßklinik
    • Coburg, Bayern, Germany, 96450
      • Klinikum Coburg GmbH
  • Brandenburg
    • Potsdam, Brandenburg, Germany, 14471
      • Kardiologische Gemeinschaftspraxis am Park Sanssouci
  • NRW
    • Bad Oeynhausen, NRW, Germany, 32545
      • Herz- und Diabeteszentrum NRW
  • Sachsen
    • Dresden, Sachsen, Germany, 01099
      • Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR
    • Leipzig, Sachsen, Germany, 04289
      • Herzzentrum Leipzig
• Netherlands
  • Rotterdam, Netherlands, 3015
    • Erasmus Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Each participating site will enroll 10 consecutive conventional AF patients who are treated according to the standard routine of the center. Patients eligible should be in accordance with the AF Guidelines.

Description

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 and the daily routine of the center.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Acute Success	Acute Success was defined as elimination (by ablation) of pulmonary vein triggers during the procedure	day of procedure
Number of Participants With 12-Month Effectiveness	Effectiveness success was defined as single procedure freedom from AF recurrence at 12-months after index procedure, excluding a 3-month blanking period.	12 months after initial AF ablation
Number of Participants With Acute Safety Success	Acute safety success was defined as freedom from Serious Adverse Events 7 days after initial AF ablation	7 days after initial AF ablation
Number of Participants With 12-Month Safety Success	12-Month safety success was defined as freedom from Serious Averse Events at 12-months after index procedure	12-months after index procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With 6-month Safety Success	6-Month safety success was defined as freedom from Serious Adverse Events 6-months after index procedure	6-months after index procedure

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Collaborators: I-Med-Pro GmbH
• Investigators: Principal Investigator: Gerhard Hindricks, Prof. Dr., Herzzentrum Leipzig - Universitätsklinik

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): May 31, 2017
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: March 30, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimate): April 2, 2015

Study Record Updates

• Last Update Posted (Actual): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: C-FIRM-02