Atrial FibrillationRe-DoNCT03314753

FIRE AND ICE Re-Ablations (Retrospective Data Collection)

An observational study of Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 13 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Retrospective data collection on re-ablations performed within the FIRE AND ICE Trial. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Atrial Fibrillation, Paroxysmal Atrial Fibrillation
How many people: 89 participants
Where: 13 sitesin 6 countries
Study dates: 18 Jan 2018to 28 Jun 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

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).

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

13 sites in 6 countries.

Country

City, postcode or hospital

13 sites in 6 countries

Germany5 sites

Herz-Zentrum Bad Krozingen
Bad Krozingen, 79189
Cardioangiologisches Centrum Bethanien CCB
Frankfurt am Main, 60431
Universitätsmedizin Greifswald
Greifswald, 17475
Asklepios Klinik St. Georg Hamburg
Hamburg, 20099
Herz-Zentrum Bodensee
Konstanz, 78464

Other trials in Germany

Spain4 sites

Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Clinico San Carlos Madrid
Madrid, 28040
Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010
Hospital Clinico Universitario Valencia
Valencia, 46010

Other trials in Spain

Czechia1 site

Nemocnice Na Homolce Praha
Prague, 15030

Other trials in Czechia

France1 site

Clinique Pasteur Toulouse
Toulouse, 31076

Other trials in France

Netherlands1 site

Isala Klinieken Zwolle
Zwolle, 8025

Other trials in Netherlands

Switzerland1 site

Universitätsspital Basel
Basel, 4031

Other trials in Switzerland

About this study

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

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

Read the 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.

Conditions: Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Being tested: No interventions - retrospective data collection
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No interventions - retrospective data collectionOther
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

Study groups in NCT03314753
Study group	Role	What they receive
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. Receives: 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. Receives: Other: No interventions - retrospective data collection

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Date of hospital discharge, assessed during the 36 month FU period
Number of Participatns With Adenosine Testing
Number of participants with adenosine testing
Measured: At time of re-ablation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jan 201828 Jun 2018

First posted19 Oct 2017
Study start18 Jan 2018
Primary completion28 Jun 2018
Study completion28 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Retrospective
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03314753
Sponsor's protocol ID: MDT17038
Acronym: Re-Do
Status last verified: Feb 2025
First submitted: 25 Sep 2017
Last updated: 13 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 31693319

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: FIRE AND ICE Re-Ablations: Retrospective Data Collection on Re-ablations Performed Within the FIRE AND ICE Trial
ClinicalTrials.gov ID: NCT03314753
Acronym / sponsor ID: Re-Do / MDT17038
Conditions: Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
Study start: 18 Jan 2018 (actual)
Primary completion: 28 Jun 2018 (actual)
Study completion: 28 Jun 2018 (actual)
First posted: 19 Oct 2017 (actual)
Results: Posted 16 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Other
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Cryoballoon Arm from FIRE AND ICE Trial	–	Other: No interventions - retrospective data collectionNo 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.
Radiofrequency Arm from FIRE AND ICE Trial	–	Other: No interventions - retrospective data collectionNo 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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).

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No interventions - retrospective data collectionNo new patients will be enrolled within this project; only retrospective data will be collected on performed re-ablations within the FIRE AND ICE Trial	Other	Cryoballoon Arm from FIRE AND ICE Trial, Radiofrequency Arm from FIRE AND ICE Trial

Primary outcome

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
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
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
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
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
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
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
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
Number of Participatns With Adenosine Testing
Time frame: At time of re-ablation
Number of participants with adenosine testing

Results and safety

Results posted to the registry on 16 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Radiofrequency Arm From FIRE AND ICE Trial	53	53
Cryoballoon Arm From FIRE AND ICE Trial	36	36

Primary outcome: Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation

Time frame: At time of re-ablation. Count of participants. Unit: Participants

Measure	Radiofrequency Arm From FIRE AND ICE Trial n = 53	Cryoballoon Arm From FIRE AND ICE Trial n = 36
Paroxysmal Atrial Fibrillation (PAF)	36	25
Persistent Atrial Fibrillation	7	5
Atrial Tachycardia (AT)/Atrial Flutter (AFL)	6	5
Atrial Fibrillation/Supraventricular Tachycardia	3	0
Other	1	1

Primary outcome: 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. Mean (Standard Deviation). Unit: Reconnected Pulmonary Veins

Measure	Radiofrequency Arm From FIRE AND ICE Trial n = 53	Cryoballoon Arm From FIRE AND ICE Trial n = 36
Value	2.1 (1.4)	1.4 (1.1)

Primary outcome: Number of Gaps and Location of Gaps Present in Pulmonary Vein Ablation Lesions Per Participant

Time frame: At time of re-ablation

Population analysed: Data were not collected; no standard documention and therfore not available in the reviewed medical files in the required detail

Primary outcome: Number of Pulmonary Veins Ablation - Ablation Lesion Sets Created During Re-ablation Procedure

Time frame: At time of re-ablation. Mean (Standard Deviation). Unit: Pulmonary Veins ablated

Measure	Radiofrequency Arm From FIRE AND ICE Trial n = 53	Cryoballoon Arm From FIRE AND ICE Trial n = 36
Value	2.4 (1.4)	1.8 (1.4)

Population analysed: The number of lesion sets for each patient was counted for this objective. If a patient had multiple pulmonary veins ablated during the re-ablation procedure, each pulmonary vein was counted as a lesion set towards the patients total count.

Adverse events

Time frame: Within this retrospective data collection, no additional or new safety data was collected. Safety reporting on all events was already performed as part of the original FIRE AND ICE Trial.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Radiofrequency Arm From FIRE AND ICE Trial	0 of 0	0 of 0	0
Cryoballoon Arm From FIRE AND ICE Trial	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31693319Kuck 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.
Individual participant dataSharing planned: No

Related trials for Atrial Fibrillation

Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruitingPhase 4
A Comparison of Beta-blockers and Calcium Channel Blockers in Atrial Fibrillation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

13 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 13 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany, Spain, Czechia, France, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation (time frame: At time of re-ablation). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03314753, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.