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Status:

COMPLETED

FIRE AND ICE Re-Ablations (Retrospective Data Collection)

Lead Sponsor:

Medtronic Cardiac Ablation Solutions

Conditions:

Atrial Fibrillation

Paroxysmal Atrial Fibrillation

Eligibility:

All Genders

18-75 years

Brief Summary

Retrospective data collection on re-ablations performed within the FIRE AND ICE Trial.

Detailed Description

The purpose of this retrospective data collection on re-ablations performed in both treatment arms (Cryo arm and Radiofrequency arm) of the FIRE AND ICE Trial is to gain insight into re-occurrence of ...

Eligibility Criteria

Inclusion

  • N/A - no new patients will be enrolled within this project.
  • Inclusion Criteria for the FIRE AND ICE Trial included:
  • Symptomatic paroxysmal atrial fibrillation (PAF) with at least two episodes and at least one episode documented (30 seconds episode length, documented by electrocardiogram (ECG) within last 12 months
  • Documented treatment failure for effectiveness of at least one anti-arrythmic drug (AAD Type I or III, including Beta-Blocker and AAD intolerance)
  • 18 to 75 years of age
  • Patients who are mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol
  • Patient is able to verbally acknowledge and understand the associated risks, benefits, and treatment alternatives to therapeutic options of this trial: cryoballoon ablation system or standard radiofrequency (RF) ablation technique.
  • The exclusion criteria were grouped as follows in the FIRE AND ICE Trial:
  • General exclusion criteria
  • Exclusion criteria related to the cardiac condition
  • Exclusion criteria based on laboratory abnormalities

Exclusion

    Key Trial Info

    Start Date :

    January 18 2018

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    June 28 2018

    Estimated Enrollment :

    89 Patients enrolled

    Trial Details

    Trial ID

    NCT03314753

    Start Date

    January 18 2018

    End Date

    June 28 2018

    Last Update

    February 13 2025

    Active Locations (13)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (13 locations)

    1

    Nemocnice Na Homolce Praha

    Prague, Czechia, 15030

    2

    Clinique Pasteur Toulouse

    Toulouse, France, 31076

    3

    Herz-Zentrum Bad Krozingen

    Bad Krozingen, Germany, 79189

    4

    Cardioangiologisches Centrum Bethanien CCB

    Frankfurt am Main, Germany, 60431