FIRE AND ICE Re-Ablations (Retrospective Data Collection) (Re-Do)

FIRE AND ICE Re-Ablations: Retrospective Data Collection on Re-ablations Performed Within the FIRE AND ICE Trial

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Other: No interventions - retrospective data collection

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 atrial arrhythmias resulting in a re-ablation after a performed index ablation procedure. Data to be collected from subject charts include pulmonary vein anatomy, documented atrial arrhythmias prior to re-ablation, pulmonary vein reconnection, pulmonary vein ablation lesion gaps and gap location, ablation lesions performed during the re-ablation, procedure parameters of the RF or cryo catheter utilized during the re-ablation, and success of re-ablations performed.

• Study Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

• Czechia
  • Praha, Czechia, 15030
    • Nemocnice Na Homolce Praha
• France
  • Toulouse, France, 31076
    • Clinique Pasteur Toulouse
• Germany
  • Bad Krozingen, Germany, 79189
    • Herz-Zentrum Bad Krozingen
  • Frankfurt am Main, Germany, 60431
    • Cardioangiologisches Centrum Bethanien CCB
  • Greifswald, Germany, 17475
    • Universitätsmedizin Greifswald
  • Hamburg, Germany, 20099
    • Asklepios Klinik St. Georg Hamburg
  • Konstanz, Germany, 78464
    • Herz-Zentrum Bodensee
• Netherlands
  • Zwolle, Netherlands, 8025
    • Isala Klinieken Zwolle
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic de Barcelona
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos Madrid
  • Málaga, Spain, 29010
    • Hospital Clinico Universitario Virgen de la Victoria
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario Valencia
• Switzerland
  • Basel, Switzerland, 4031
    • Universitätsspital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The FIRE AND ICE Trial collected data to compare efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with drug refractory symptomatic paroxysmal atrial fibrillation (PAF).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cryoballoon Arm from FIRE AND ICE Trial; No new/additional patients will be enrolled within this project. Only retrospective data will be collected on performed re-ablation procedures within the FIRE AND ICE Trial. The FIRE AND ICE Trial collected data to compare efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus (Cryoballoon Arm) a radiofrequency ablation (RF Arm) with a ThermoCool catheter in patients with drug refractory symptomatic paroxysmal atrial fibrillation (AF). Products Used within the FIRE AND ICE Trial: Arctic Front® & Arctic Front Advance® Cardiac CryoAblation Catheter System. 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.	Other: No interventions - retrospective data collection; No new patients will be enrolled within this project; only retrospective data will be collected on performed re-ablations within the FIRE AND ICE Trial
Radiofrequency Arm from FIRE AND ICE Trial; No new/additional patients will be enrolled within this project. Only retrospective data will be collected on performed re-ablation procedures within the FIRE AND ICE Trial. The FIRE AND ICE Trial collected data to compare efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus (Cryoballoon Arm) a radiofrequency ablation (RF Arm) with a ThermoCool catheter in patients with drug refractory symptomatic paroxysmal atrial fibrillation (AF). Products Used within the FIRE AND ICE Trial: NaviStar® ThermoCool® Ablation Catheter (Radiofrequency Arm; Manufacturer Biosense Webster, Inc.). 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.	Other: No interventions - retrospective data collection; No new patients will be enrolled within this project; only retrospective data will be collected on performed re-ablations within the FIRE AND ICE Trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation	Number of documented atrial arrhythmias as assessed by ECG prior to the re-ablation	At time of re-ablation
Number of Reconnected Pulmonary Veins as Documented in the Cath Lab / Imaging at the Time of Re-ablation Procedure	Number of reconnected pulmonary veins as documented in cath lab / imaging	At time of re-ablation
Number of Gaps and Location of Gaps Present in Pulmonary Vein Ablation Lesions Per Participant	Number of gaps and location of gaps present in pulmonary vein ablation lesions as seen in the cath lab / imaging	At time of re-ablation
Number of Pulmonary Veins Ablation - Ablation Lesion Sets Created During Re-ablation Procedure	Description of all ablation lesion sets created during re-ablation procedure	At time of re-ablation
Percentage of Participants With Acute Procedural Success of Re-ablation Procedure	Summarize acute procedural success of re-ablation procedure per treatment arm	At time of re-ablation
Re-ablation Procedure Times as Measured in the Cath Lab	Re-ablation procedure times as measured in the cath lab	At time of re-ablation
Number of Hospital Days for Re-ablation Procedure Form Admission to Discharge	Number of hospital days for re-ablation procedure form admission to discharge	From Date of Hospital admission until the date of hospital discharge up to 36 month FU period
Number of Participants With Anti-arrhythmic Drug Use at Time of Discharge From the Re-ablation Procedure	Anti-arrhythmic drug use at time of discharge from the re-ablation procedure via medical log on AADs	Date of hospital discharge, assessed during the 36 month FU period
Number of Participatns With Adenosine Testing	Number of participants with adenosine testing	At time of re-ablation

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Ablation Solutions

Publications and helpful links

General Publications

• Kuck KH, Albenque JP, Chun KJ, Furnkranz A, Busch M, Elvan A, Schluter M, Braegelmann KM, Kueffer FJ, Hemingway L, Arentz T, Tondo C, Brugada J; FIRE AND ICE Investigators. Repeat Ablation for Atrial Fibrillation Recurrence Post Cryoballoon or Radiofrequency Ablation in the FIRE AND ICE Trial. Circ Arrhythm Electrophysiol. 2019 May 22;12(6):e007247. doi: 10.1161/CIRCEP.119.007247.

Helpful Links

• CircEP - FIRE AND ICE Re-Ablation Manuscript

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2018
• Primary Completion (Actual): June 28, 2018
• Study Completion (Actual): June 28, 2018

Study Registration Dates

• First Submitted: September 25, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 19, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: MDT17038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No