Trial Outcomes & Findings for FIRE AND ICE Re-Ablations (Retrospective Data Collection) (NCT NCT03314753)
NCT ID: NCT03314753
Last Updated: 2025-02-13
Results Overview
Number of documented atrial arrhythmias as assessed by ECG prior to the re-ablation
Recruitment status
COMPLETED
Target enrollment
89 participants
Primary outcome timeframe
At time of re-ablation
Results posted on
2025-02-13
Participant Flow
110 patients reported a re-ablation in the original FIRE AND ICE Trial. Of those 110, 89 consented for the FIRE AND ICE Re-Ablation study. All data available in retrospective chart review from the 89 subjects were included in analyses. No patient data was excluded. The first re-ablation for each patient was included in the analysis.
Participant milestones
| Measure |
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.
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
|
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.
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
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
36
|
|
Overall Study
COMPLETED
|
53
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Radiofrequency Arm From FIRE AND ICE Trial
n=53 Participants
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.
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
|
Cryoballoon Arm From FIRE AND ICE Trial
n=36 Participants
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.
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
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 10 • n=53 Participants
|
62 years
STANDARD_DEVIATION 11 • n=36 Participants
|
61 years
STANDARD_DEVIATION 10 • n=89 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=53 Participants
|
21 Participants
n=36 Participants
|
41 Participants
n=89 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=53 Participants
|
15 Participants
n=36 Participants
|
48 Participants
n=89 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Netherlands
|
5 participants
n=53 Participants
|
1 participants
n=36 Participants
|
6 participants
n=89 Participants
|
|
Region of Enrollment
Czechia
|
3 participants
n=53 Participants
|
0 participants
n=36 Participants
|
3 participants
n=89 Participants
|
|
Region of Enrollment
France
|
1 participants
n=53 Participants
|
1 participants
n=36 Participants
|
2 participants
n=89 Participants
|
|
Region of Enrollment
Switzerland
|
2 participants
n=53 Participants
|
5 participants
n=36 Participants
|
7 participants
n=89 Participants
|
|
Region of Enrollment
Germany
|
34 participants
n=53 Participants
|
25 participants
n=36 Participants
|
59 participants
n=89 Participants
|
|
Region of Enrollment
Spain
|
8 participants
n=53 Participants
|
4 participants
n=36 Participants
|
12 participants
n=89 Participants
|
|
Diagnosed with paroxysmal atrial fibrillation (PAF) [year]
|
6.1 years
STANDARD_DEVIATION 6.5 • n=53 Participants
|
5.5 years
STANDARD_DEVIATION 4.5 • n=36 Participants
|
5.9 years
STANDARD_DEVIATION 5.7 • n=89 Participants
|
|
BodyMassIndex (BMI) [kg/m^2]
|
27 kg/m^2
STANDARD_DEVIATION 4 • n=53 Participants
|
28 kg/m^2
STANDARD_DEVIATION 5 • n=36 Participants
|
28 kg/m^2
STANDARD_DEVIATION 4 • n=89 Participants
|
|
Height [cm]
|
176 cm
STANDARD_DEVIATION 10 • n=53 Participants
|
170 cm
STANDARD_DEVIATION 9 • n=36 Participants
|
173 cm
STANDARD_DEVIATION 10 • n=89 Participants
|
|
Weight [kg]
|
85 kg
STANDARD_DEVIATION 16 • n=53 Participants
|
81 kg
STANDARD_DEVIATION 15 • n=36 Participants
|
83 kg
STANDARD_DEVIATION 15 • n=89 Participants
|
|
New York Heart Association (NYHA) Class
Patient does not have heart failure
|
39 Participants
n=53 Participants
|
22 Participants
n=36 Participants
|
61 Participants
n=89 Participants
|
|
New York Heart Association (NYHA) Class
NYHA Class I
|
3 Participants
n=53 Participants
|
4 Participants
n=36 Participants
|
7 Participants
n=89 Participants
|
|
New York Heart Association (NYHA) Class
NYHA Class II
|
11 Participants
n=53 Participants
|
10 Participants
n=36 Participants
|
21 Participants
n=89 Participants
|
|
New York Heart Association (NYHA) Class
NYHA Class not available
|
0 Participants
n=53 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=89 Participants
|
|
Left Atrial Diameter (LAD) [mm]
|
41.6 mm
STANDARD_DEVIATION 5.7 • n=53 Participants
|
39.4 mm
STANDARD_DEVIATION 7.9 • n=36 Participants
|
40.6 mm
STANDARD_DEVIATION 6.8 • n=89 Participants
|
|
Left Ventricular Ejection Fraction (LVEF) [%]
|
62 %
STANDARD_DEVIATION 7 • n=53 Participants
|
62 %
STANDARD_DEVIATION 7 • n=36 Participants
|
62 %
STANDARD_DEVIATION 7 • n=89 Participants
|
|
Left Ventricular End Diastolic Diameter (LVEDD) [mm]
|
51 mm
STANDARD_DEVIATION 4 • n=53 Participants
|
51 mm
STANDARD_DEVIATION 5 • n=36 Participants
|
51 mm
STANDARD_DEVIATION 5 • n=89 Participants
|
|
Left Atrium (LA) Volume [mL]
|
73 mL
STANDARD_DEVIATION 35 • n=53 Participants
|
62 mL
STANDARD_DEVIATION 41 • n=36 Participants
|
69 mL
STANDARD_DEVIATION 36 • n=89 Participants
|
|
Prior Direct Current Cardioversion (DCCV)
|
15 participants
n=53 Participants
|
8 participants
n=36 Participants
|
23 participants
n=89 Participants
|
|
History of Atrial Flutter
|
11 participants
n=53 Participants
|
6 participants
n=36 Participants
|
17 participants
n=89 Participants
|
|
Prior Stroke
|
2 participants
n=53 Participants
|
2 participants
n=36 Participants
|
4 participants
n=89 Participants
|
|
Coronary Artery Disease (CAD)
|
3 participants
n=53 Participants
|
1 participants
n=36 Participants
|
4 participants
n=89 Participants
|
|
Prior Myocardial Infarction (MI)
|
1 participants
n=53 Participants
|
0 participants
n=36 Participants
|
1 participants
n=89 Participants
|
|
Aortic Valve Stenosis
|
0 participants
n=53 Participants
|
0 participants
n=36 Participants
|
0 participants
n=89 Participants
|
|
Peripheral Artery Disease
|
0 participants
n=53 Participants
|
0 participants
n=36 Participants
|
0 participants
n=89 Participants
|
|
Hyperlipidemia
|
13 participants
n=53 Participants
|
12 participants
n=36 Participants
|
25 participants
n=89 Participants
|
|
Diabetes Type I or II
|
5 participants
n=53 Participants
|
4 participants
n=36 Participants
|
9 participants
n=89 Participants
|
|
Hypertension
|
32 participants
n=53 Participants
|
22 participants
n=36 Participants
|
54 participants
n=89 Participants
|
|
Prior Coronary Artery Bypass Graft (CABG)
|
2 participants
n=53 Participants
|
0 participants
n=36 Participants
|
2 participants
n=89 Participants
|
|
Prior Percutaneous Coronary Intervention (PCI)
|
2 participants
n=53 Participants
|
0 participants
n=36 Participants
|
2 participants
n=89 Participants
|
|
Antiarrhythmic Druc (AAD) at discharge
|
18 participants
n=53 Participants
|
14 participants
n=36 Participants
|
32 participants
n=89 Participants
|
|
HATCH Score
|
1.2 units on a scale
STANDARD_DEVIATION 1.1 • n=53 Participants
|
1.5 units on a scale
STANDARD_DEVIATION 1.2 • n=36 Participants
|
1.3 units on a scale
STANDARD_DEVIATION 1.1 • n=89 Participants
|
|
Systolic Blood Pressure
|
134 mmHG
STANDARD_DEVIATION 24 • n=53 Participants
|
133 mmHG
STANDARD_DEVIATION 22 • n=36 Participants
|
134 mmHG
STANDARD_DEVIATION 23 • n=89 Participants
|
|
Diastolic Blood Pressure
|
79 mmHG
STANDARD_DEVIATION 13 • n=53 Participants
|
76 mmHG
STANDARD_DEVIATION 11 • n=36 Participants
|
78 mmHG
STANDARD_DEVIATION 12 • n=89 Participants
|
|
Glomerular Filtration Rate (GFR)
|
75 mL/min/m2
STANDARD_DEVIATION 16 • n=53 Participants
|
77 mL/min/m2
STANDARD_DEVIATION 19 • n=36 Participants
|
76 mL/min/m2
STANDARD_DEVIATION 17 • n=89 Participants
|
|
CHA2DS2-VASc
|
1.8 units on a scale
STANDARD_DEVIATION 1.3 • n=53 Participants
|
2.3 units on a scale
STANDARD_DEVIATION 1.3 • n=36 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 1.3 • n=89 Participants
|
PRIMARY outcome
Timeframe: At time of re-ablationNumber of documented atrial arrhythmias as assessed by ECG prior to the re-ablation
Outcome measures
| Measure |
Radiofrequency Arm From FIRE AND ICE Trial
n=53 Participants
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.
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
|
Cryoballoon Arm From FIRE AND ICE Trial
n=36 Participants
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.
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
|
|---|---|---|
|
Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation
Paroxysmal Atrial Fibrillation (PAF)
|
36 Participants
|
25 Participants
|
|
Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation
Persistent Atrial Fibrillation
|
7 Participants
|
5 Participants
|
|
Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation
Atrial Tachycardia (AT)/Atrial Flutter (AFL)
|
6 Participants
|
5 Participants
|
|
Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation
Atrial Fibrillation/Supraventricular Tachycardia
|
3 Participants
|
0 Participants
|
|
Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation
Other
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At time of re-ablationNumber of reconnected pulmonary veins as documented in cath lab / imaging
Outcome measures
| Measure |
Radiofrequency Arm From FIRE AND ICE Trial
n=53 Participants
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.
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
|
Cryoballoon Arm From FIRE AND ICE Trial
n=36 Participants
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.
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
|
|---|---|---|
|
Number of Reconnected Pulmonary Veins as Documented in the Cath Lab / Imaging at the Time of Re-ablation Procedure
|
2.1 Reconnected Pulmonary Veins
Standard Deviation 1.4
|
1.4 Reconnected Pulmonary Veins
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: At time of re-ablationPopulation: Data were not collected; no standard documention and therfore not available in the reviewed medical files in the required detail
Number of gaps and location of gaps present in pulmonary vein ablation lesions as seen in the cath lab / imaging
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At time of re-ablationPopulation: 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.
Description of all ablation lesion sets created during re-ablation procedure
Outcome measures
| Measure |
Radiofrequency Arm From FIRE AND ICE Trial
n=53 Participants
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.
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
|
Cryoballoon Arm From FIRE AND ICE Trial
n=36 Participants
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.
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
|
|---|---|---|
|
Number of Pulmonary Veins Ablation - Ablation Lesion Sets Created During Re-ablation Procedure
|
2.4 Pulmonary Veins ablated
Standard Deviation 1.4
|
1.8 Pulmonary Veins ablated
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: At time of re-ablationPopulation: A patient was defined as an acute success if all ablation attempts within the re-ablation procedure were reported as successful. Pulmonary Vein Isolation (PVI) was assessed minimally via documented entrance block, and where assessable exit block (electrical signal detection).
Summarize acute procedural success of re-ablation procedure per treatment arm
Outcome measures
| Measure |
Radiofrequency Arm From FIRE AND ICE Trial
n=53 Participants
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.
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
|
Cryoballoon Arm From FIRE AND ICE Trial
n=36 Participants
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.
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
|
|---|---|---|
|
Percentage of Participants With Acute Procedural Success of Re-ablation Procedure
|
90.4 percentage of patients with acute succes
|
93.9 percentage of patients with acute succes
|
PRIMARY outcome
Timeframe: At time of re-ablationRe-ablation procedure times as measured in the cath lab
Outcome measures
| Measure |
Radiofrequency Arm From FIRE AND ICE Trial
n=53 Participants
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.
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
|
Cryoballoon Arm From FIRE AND ICE Trial
n=36 Participants
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.
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
|
|---|---|---|
|
Re-ablation Procedure Times as Measured in the Cath Lab
|
122 minutes
Standard Deviation 53
|
103 minutes
Standard Deviation 33
|
PRIMARY outcome
Timeframe: From Date of Hospital admission until the date of hospital discharge up to 36 month FU periodNumber of hospital days for re-ablation procedure form admission to discharge
Outcome measures
| Measure |
Radiofrequency Arm From FIRE AND ICE Trial
n=53 Participants
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.
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
|
Cryoballoon Arm From FIRE AND ICE Trial
n=36 Participants
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.
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
|
|---|---|---|
|
Number of Hospital Days for Re-ablation Procedure Form Admission to Discharge
|
2.6 nights
Standard Deviation 2.1
|
2.5 nights
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: Date of hospital discharge, assessed during the 36 month FU periodAnti-arrhythmic drug use at time of discharge from the re-ablation procedure via medical log on AADs
Outcome measures
| Measure |
Radiofrequency Arm From FIRE AND ICE Trial
n=53 Participants
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.
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
|
Cryoballoon Arm From FIRE AND ICE Trial
n=36 Participants
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.
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
|
|---|---|---|
|
Number of Participants With Anti-arrhythmic Drug Use at Time of Discharge From the Re-ablation Procedure
|
30 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: At time of re-ablationNumber of participants with adenosine testing
Outcome measures
| Measure |
Radiofrequency Arm From FIRE AND ICE Trial
n=53 Participants
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.
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
|
Cryoballoon Arm From FIRE AND ICE Trial
n=36 Participants
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.
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
|
|---|---|---|
|
Number of Participatns With Adenosine Testing
|
10 Participants
|
4 Participants
|
Adverse Events
Radiofrequency Arm From FIRE AND ICE Trial
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cryoballoon Arm From FIRE AND ICE Trial
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publications from this retrospective data collection are regulated separately in the publication plan, which was reviewed and approved by the Publication Committee. Medical Centers / Investigators may publish the results of work performed under the applicable site agreement. Any such publication shall be at a time determined by Medtronic and shall be provided to Medtronic for review at least 60 days prior to submission or presentation.
- Publication restrictions are in place
Restriction type: OTHER