FIRE AND ICE Re-Ablations (Retrospective Data Collection)

Overview

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

Full Title of Study: “FIRE AND ICE Re-Ablations: Retrospective Data Collection on Re-ablations Performed Within the FIRE AND ICE Trial”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: June 28, 2018

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medtronic Cardiac Rhythm and Heart Failure
  • Provider of Information About this Clinical Study
    • Sponsor

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