Topera C-FIRM Registry

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02407249
• Other study ID #: C-FIRM-02
• Status: Completed
• Start date: April 2015
• Est. completion date: July 31, 2018

Study information

• Verified date: October 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Prospective and retrospective enrollment possible

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• 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 and the daily routine of the center.

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	6-Month safety success was defined as freedom from Serious Adverse Events 6-months after index procedure	6-months after index procedure
Primary	Number of Participants With Acute Success	Acute Success was defined as elimination (by ablation) of pulmonary vein triggers during the procedure	day of procedure
Primary	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
Primary	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
Primary	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