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Completed

NCT Number: NCT03314753

FIRE AND ICE Re-Ablations (Retrospective Data Collection)

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Paroxysmal Atrial Fibrillation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nemocnice Na Homolce Praha, Prague, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Number of Participatns With Adenosine Testing

    Time frame: At time of re-ablation

    Number of participants with adenosine testing

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Ablation Solutions

Industry

Registry information

Official study title

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

Acronym: Re-Do

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 19, 2017
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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