FIRE AND ICE Re-Ablations (Retrospective Data Collection)

Atrial Fibrillation Clinical Trial

— Re-Do  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03314753
• Other study ID #: MDT17038
• Status: Completed
• Start date: January 18, 2018
• Est. completion date: June 28, 2018

Study information

• Verified date: September 2019
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: June 28, 2018
• Est. primary completion date: June 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Other:
• No interventions - retrospective data collection
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

Locations

Country	Name	City	State
Czechia	Nemocnice Na Homolce Praha	Praha
France	Clinique Pasteur Toulouse	Toulouse
Germany	Herz-Zentrum Bad Krozingen	Bad Krozingen
Germany	Cardioangiologisches Centrum Bethanien CCB	Frankfurt am Main
Germany	Universitätsmedizin Greifswald	Greifswald
Germany	Asklepios Klinik St. Georg Hamburg	Hamburg
Germany	Herz-Zentrum Bodensee	Konstanz
Netherlands	Isala Klinieken Zwolle	Zwolle
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Clinico San Carlos Madrid	Madrid
Spain	Hospital Clinico Universitario Virgen de la Victoria	Málaga
Spain	Hospital Clinico Universitario Valencia	Valencia
Switzerland	Universitätsspital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

Czechia,  France,  Germany,  Netherlands,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of Participatns With Adenosine Testing	Number of participants with adenosine testing	At time of re-ablation

External Links

•   CircEP - FIRE AND ICE Re-Ablation Manuscript