FIRE AND ICE II Trial Pilot
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- STATUS
- Recruiting
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- End date
- May 30, 2025
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- participants needed
- 60
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- sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Summary
The FIRE AND ICE II Trial (Pilot) is the pilot phase of a prospective, randomized, single-blinded, multi-center, interventional post-market clinical trial, comparing efficacy and safety of isolation of the pulmonary veins (PVI) using a Cryoballoon catheter or radiofrequency ablation with a ThermoCool® Smarttouch® catheter in subjects with persistent atrial fibrillation (AF).
Description
60 patients with persistent AF will be randomized 1:1 between Cryoballoon ablation and Radiofrequency ablation in the FIRE AND ICE II Trial Pilot at 5 clinical sites in Europe.
The data collected within the pilot phase will be reviewed and a decision on extending the trial with an extended number of patients and sites as main phase will be taken.
Details
| Condition | Persistent Atrial Fibrillation, Atrial Arrhythmia |
|---|---|
| Treatment | Cryoballoon (Arctic Front Advance Cryoballoon), Radiofrequency Catheter (ThermoCool Smarttouch) |
| Clinical Study Identifier | NCT03706677 |
| Sponsor | Medtronic Cardiac Rhythm and Heart Failure |
| Last Modified on | 24 March 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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