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

Medtronic Cardiac Ablation Solutions

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation; Atrial Fibrillation

Treatments: Other: No interventions - retrospective data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT03314753

MDT17038

Details and patient eligibility

About

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

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

89 participants in 2 patient groups

Cryoballoon Arm from FIRE AND ICE Trial

Description:

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.

Treatment:

Other: No interventions - retrospective data collection

Radiofrequency Arm from FIRE AND ICE Trial

Description:

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.

Treatment:

Other: No interventions - retrospective data collection