N/A
Completed N=89
FIRE AND ICE Re-Ablations (Retrospective Data Collection)
Source: ClinicalTrials.gov NCT03314753 ↗Enrolled (actual)
89
Serious AEs
—
Results posted
Sep 2019
Primary outcomePrimary: Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation — 36; 25; 7; 5 Participants
Summary
Retrospective data collection on re-ablations performed within the FIRE AND ICE Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation |
36; 25; 7; 5; 6; 5 | — |
| PRIMARY Number of Reconnected Pulmonary Veins as Documented in the Cath Lab / Imaging at the Time of Re-ablation Procedure |
2.1; 1.4 | — |
| PRIMARY Number of Gaps and Location of Gaps Present in Pulmonary Vein Ablation Lesions Per Participant |
— | — |
| PRIMARY Number of Pulmonary Veins Ablation - Ablation Lesion Sets Created During Re-ablation Procedure |
2.4; 1.8 | — |
| PRIMARY Percentage of Participants With Acute Procedural Success of Re-ablation Procedure |
90.4; 93.9 | — |
| PRIMARY Re-ablation Procedure Times as Measured in the Cath Lab |
122; 103 | — |
| PRIMARY Number of Hospital Days for Re-ablation Procedure Form Admission to Discharge |
2.6; 2.5 | — |
| PRIMARY Number of Participants With Anti-arrhythmic Drug Use at Time of Discharge From the Re-ablation Procedure |
30; 19 | — |
| PRIMARY Number of Participatns With Adenosine Testing |
10; 4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03314753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.