FIRE AND ICE Re-Ablations (Retrospective Data Collection)

NCT03314753 | Completed Results

• 1 other identifier: MDT17038
• Study Type: observational
• Target: 89
• Locations: 6 countries
• Sites: 13

Brief Summary

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

Conditions

Atrial Fibrillation; Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

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

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

Interventions

No interventions - retrospective data collection OTHER

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

Cryoballoon Arm from FIRE AND ICE Trial; Radiofrequency Arm from FIRE AND ICE Trial

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Medtronic Cardiac Ablation Solutions: lead

Study Sites (13)

Nemocnice Na Homolce Praha

Prague, 15030, Czechia

Location

Clinique Pasteur Toulouse

Toulouse, 31076, France

Location

Herz-Zentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Cardioangiologisches Centrum Bethanien CCB

Frankfurt am Main, 60431, Germany

Location

Universitätsmedizin Greifswald

Greifswald, 17475, Germany

Location

Asklepios Klinik St. Georg Hamburg

Hamburg, 20099, Germany

Location

Herz-Zentrum Bodensee

Konstanz, 78464, Germany

Location

Isala Klinieken Zwolle

Zwolle, 8025, Netherlands

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Clinico San Carlos Madrid

Madrid, 28040, Spain

Location

Hospital Clinico Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Clinico Universitario Valencia

Valencia, 46010, Spain

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 31693319 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Project Manager (CSM)
• Organization: Medtronic

petra.kremer@medtronic.com

00491742122

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: October 19, 2017
• Study Start: January 18, 2018
• Primary Completion: June 28, 2018
• Study Completion: June 28, 2018
• Last Updated: February 13, 2025
• Results First Posted: September 16, 2019

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); ES (4); DE (5); CZ (1); FR (1); NL (1)