Clinical trial NCT03314753: FIRE AND ICE Re-Ablations (Retrospective Data Collection)
Official title: FIRE AND ICE Re-Ablations: Retrospective Data Collection on Re-ablations Performed Within the FIRE AND ICE Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
First posted: 2017-10-19
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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).

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 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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation
timeFrame: At time of re-ablation
measure: Number of Reconnected Pulmonary Veins as Documented in the Cath Lab / Imaging at the Time of Re-ablation Procedure
timeFrame: At time of re-ablation
measure: Number of Gaps and Location of Gaps Present in Pulmonary Vein Ablation Lesions Per Participant
timeFrame: At time of re-ablation
measure: Number of Pulmonary Veins Ablation - Ablation Lesion Sets Created During Re-ablation Procedure
timeFrame: At time of re-ablation
measure: Percentage of Participants With Acute Procedural Success of Re-ablation Procedure
timeFrame: At time of re-ablation
measure: Re-ablation Procedure Times as Measured in the Cath Lab
timeFrame: At time of re-ablation
measure: Number of Hospital Days for Re-ablation Procedure Form Admission to Discharge
timeFrame: From Date of Hospital admission until the date of hospital discharge up to 36 month FU period
measure: Number of Participants With Anti-arrhythmic Drug Use at Time of Discharge From the Re-ablation Procedure
timeFrame: Date of hospital discharge, assessed during the 36 month FU period
measure: Number of Participatns With Adenosine Testing
timeFrame: At time of re-ablation
Secondary outcomes:
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Nemocnice Na Homolce Praha
city: Toulouse
country: France
facility: Clinique Pasteur Toulouse
city: Bad Krozingen
country: Germany
facility: Herz-Zentrum Bad Krozingen
city: Frankfurt am Main
country: Germany
facility: Cardioangiologisches Centrum Bethanien CCB
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg Hamburg
city: Konstanz
country: Germany
facility: Herz-Zentrum Bodensee
city: Zwolle
country: Netherlands
facility: Isala Klinieken Zwolle
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos Madrid
city: Málaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria
city: Valencia
country: Spain
facility: Hospital Clinico Universitario Valencia
city: Basel
country: Switzerland
facility: Universitätsspital Basel
Study officials:
References:
citation: 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.