Topera C-FIRM Registry

NCT02407249 | Completed Results

• 1 other identifier: C-FIRM-02
• Study Type: observational
• Target: 73
• Locations: 2 countries
• Sites: 9

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Number of Participants With 6-month Safety Success

  6-months after index procedure

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead
• I-Med-Pro GmbH: collaborator

Study Sites (9)

Städtisches Klinikum Karlsruhe GmbH

Karlsruhe, Baden-Würtemberg, 76133, Germany

Location

Herz- und Gefäßklinik

Bad Neustadt an der Saale, Bavaria, 97616, Germany

Location

Klinikum Coburg GmbH

Coburg, Bavaria, 96450, Germany

Location

Kardiologische Gemeinschaftspraxis am Park Sanssouci

Potsdam, Brandenburg, 14471, Germany

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR

Dresden, Saxony, 01099, Germany

Location

Herzzentrum Leipzig

Leipzig, Saxony, 04289, Germany

Location

Unfallkrankenhaus Berlin

Berlin, 12683, Germany

Location

Erasmus Medical Center

Rotterdam, 3015, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Program Director
• Organization: Abbott

kristin.ruffner@abbott.com

6517566717

Study Officials

• Gerhard Hindricks, Prof. Dr.

  Herzzentrum Leipzig - Universitätsklinik

  PRINCIPAL INVESTIGATOR

• Kristin Ruffner, PhD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 2, 2015
• Study Start: April 1, 2015
• Primary Completion: May 31, 2017
• Study Completion: July 31, 2018
• Last Updated: October 16, 2019
• Results First Posted: October 16, 2019

Record last verified: 2019-10

Locations

DE (8); NL (1)