FIRE AND ICE Re-Ablations (Retrospective Data Collection)

Study Overview
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Brief Summary
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Retrospective data collection on re-ablations performed within the FIRE AND ICE Trial.

Detailed Description
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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.

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

Conditions
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Atrial Fibrillation, Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Other: No interventions - retrospective data collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cryoballoon Arm from FIRE AND ICE Trial<br>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<br>* 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<br>|
| Radiofrequency Arm from FIRE AND ICE Trial<br>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<br>* 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<br>|

What is the study measuring?
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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 |