Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Conditions
Brief summary
Retrospective data collection on re-ablations performed within the FIRE AND ICE Trial.
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.
Interventions
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
Sponsors
Medtronic Cardiac Ablation Solutions
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | At time of re-ablation | Number of participants with adenosine testing |
Countries
Czechia, France, Germany, Netherlands, Spain, Switzerland
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 53 |
| 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 | 36 |
| Total | 89 |
Baseline characteristics
| Characteristic | Radiofrequency Arm From FIRE AND ICE Trial | Cryoballoon Arm From FIRE AND ICE Trial | Total |
|---|---|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 10 | 62 years STANDARD_DEVIATION 11 | 61 years STANDARD_DEVIATION 10 |
| Antiarrhythmic Druc (AAD) at discharge | 18 participants | 14 participants | 32 participants |
| Aortic Valve Stenosis | 0 participants | 0 participants | 0 participants |
| BodyMassIndex (BMI) [kg/m^2] | 27 kg/m^2 STANDARD_DEVIATION 4 | 28 kg/m^2 STANDARD_DEVIATION 5 | 28 kg/m^2 STANDARD_DEVIATION 4 |
| CHA2DS2-VASc | 1.8 units on a scale STANDARD_DEVIATION 1.3 | 2.3 units on a scale STANDARD_DEVIATION 1.3 | 2.0 units on a scale STANDARD_DEVIATION 1.3 |
| Coronary Artery Disease (CAD) | 3 participants | 1 participants | 4 participants |
| Diabetes Type I or II | 5 participants | 4 participants | 9 participants |
| Diagnosed with paroxysmal atrial fibrillation (PAF) [year] | 6.1 years STANDARD_DEVIATION 6.5 | 5.5 years STANDARD_DEVIATION 4.5 | 5.9 years STANDARD_DEVIATION 5.7 |
| Diastolic Blood Pressure | 79 mmHG STANDARD_DEVIATION 13 | 76 mmHG STANDARD_DEVIATION 11 | 78 mmHG STANDARD_DEVIATION 12 |
| Glomerular Filtration Rate (GFR) | 75 mL/min/m2 STANDARD_DEVIATION 16 | 77 mL/min/m2 STANDARD_DEVIATION 19 | 76 mL/min/m2 STANDARD_DEVIATION 17 |
| HATCH Score | 1.2 units on a scale STANDARD_DEVIATION 1.1 | 1.5 units on a scale STANDARD_DEVIATION 1.2 | 1.3 units on a scale STANDARD_DEVIATION 1.1 |
| Height [cm] | 176 cm STANDARD_DEVIATION 10 | 170 cm STANDARD_DEVIATION 9 | 173 cm STANDARD_DEVIATION 10 |
| History of Atrial Flutter | 11 participants | 6 participants | 17 participants |
| Hyperlipidemia | 13 participants | 12 participants | 25 participants |
| Hypertension | 32 participants | 22 participants | 54 participants |
| Left Atrial Diameter (LAD) [mm] | 41.6 mm STANDARD_DEVIATION 5.7 | 39.4 mm STANDARD_DEVIATION 7.9 | 40.6 mm STANDARD_DEVIATION 6.8 |
| Left Atrium (LA) Volume [mL] | 73 mL STANDARD_DEVIATION 35 | 62 mL STANDARD_DEVIATION 41 | 69 mL STANDARD_DEVIATION 36 |
| Left Ventricular Ejection Fraction (LVEF) [%] | 62 % STANDARD_DEVIATION 7 | 62 % STANDARD_DEVIATION 7 | 62 % STANDARD_DEVIATION 7 |
| Left Ventricular End Diastolic Diameter (LVEDD) [mm] | 51 mm STANDARD_DEVIATION 4 | 51 mm STANDARD_DEVIATION 5 | 51 mm STANDARD_DEVIATION 5 |
| New York Heart Association (NYHA) Class NYHA Class I | 3 Participants | 4 Participants | 7 Participants |
| New York Heart Association (NYHA) Class NYHA Class II | 11 Participants | 10 Participants | 21 Participants |
| New York Heart Association (NYHA) Class NYHA Class not available | 0 Participants | 0 Participants | 0 Participants |
| New York Heart Association (NYHA) Class Patient does not have heart failure | 39 Participants | 22 Participants | 61 Participants |
| Peripheral Artery Disease | 0 participants | 0 participants | 0 participants |
| Prior Coronary Artery Bypass Graft (CABG) | 2 participants | 0 participants | 2 participants |
| Prior Direct Current Cardioversion (DCCV) | 15 participants | 8 participants | 23 participants |
| Prior Myocardial Infarction (MI) | 1 participants | 0 participants | 1 participants |
| Prior Percutaneous Coronary Intervention (PCI) | 2 participants | 0 participants | 2 participants |
| Prior Stroke | 2 participants | 2 participants | 4 participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Czechia | 3 participants | 0 participants | 3 participants |
| Region of Enrollment France | 1 participants | 1 participants | 2 participants |
| Region of Enrollment Germany | 34 participants | 25 participants | 59 participants |
| Region of Enrollment Netherlands | 5 participants | 1 participants | 6 participants |
| Region of Enrollment Spain | 8 participants | 4 participants | 12 participants |
| Region of Enrollment Switzerland | 2 participants | 5 participants | 7 participants |
| Sex: Female, Male Female | 20 Participants | 21 Participants | 41 Participants |
| Sex: Female, Male Male | 33 Participants | 15 Participants | 48 Participants |
| Systolic Blood Pressure | 134 mmHG STANDARD_DEVIATION 24 | 133 mmHG STANDARD_DEVIATION 22 | 134 mmHG STANDARD_DEVIATION 23 |
| Weight [kg] | 85 kg STANDARD_DEVIATION 16 | 81 kg STANDARD_DEVIATION 15 | 83 kg STANDARD_DEVIATION 15 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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
Time frame: At time of re-ablation
Population: Data were not collected; no standard documention and therfore not available in the reviewed medical files in the required detail
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
Time frame: From Date of Hospital admission until the date of hospital discharge up to 36 month FU period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiofrequency Arm From FIRE AND ICE Trial | Number of Hospital Days for Re-ablation Procedure Form Admission to Discharge | 2.6 nights | Standard Deviation 2.1 |
| Cryoballoon Arm From FIRE AND ICE Trial | Number of Hospital Days for Re-ablation Procedure Form Admission to Discharge | 2.5 nights | Standard Deviation 2.7 |
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
Time frame: Date of hospital discharge, assessed during the 36 month FU period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Radiofrequency Arm From FIRE AND ICE Trial | Number of Participants With Anti-arrhythmic Drug Use at Time of Discharge From the Re-ablation Procedure | 30 Participants |
| Cryoballoon Arm From FIRE AND ICE Trial | Number of Participants With Anti-arrhythmic Drug Use at Time of Discharge From the Re-ablation Procedure | 19 Participants |
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
Time frame: At time of re-ablation
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Radiofrequency Arm From FIRE AND ICE Trial | Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation | Paroxysmal Atrial Fibrillation (PAF) | 36 Participants |
| Radiofrequency Arm From FIRE AND ICE Trial | Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation | Atrial Fibrillation/Supraventricular Tachycardia | 3 Participants |
| Radiofrequency Arm From FIRE AND ICE Trial | Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation | Atrial Tachycardia (AT)/Atrial Flutter (AFL) | 6 Participants |
| Radiofrequency Arm From FIRE AND ICE Trial | Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation | Other | 1 Participants |
| Radiofrequency Arm From FIRE AND ICE Trial | Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation | Persistent Atrial Fibrillation | 7 Participants |
| Cryoballoon Arm From FIRE AND ICE Trial | Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation | Other | 1 Participants |
| Cryoballoon Arm From FIRE AND ICE Trial | Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation | Paroxysmal Atrial Fibrillation (PAF) | 25 Participants |
| Cryoballoon Arm From FIRE AND ICE Trial | Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation | Atrial Tachycardia (AT)/Atrial Flutter (AFL) | 5 Participants |
| Cryoballoon Arm From FIRE AND ICE Trial | Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation | Atrial Fibrillation/Supraventricular Tachycardia | 0 Participants |
| Cryoballoon Arm From FIRE AND ICE Trial | Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation | Persistent Atrial Fibrillation | 5 Participants |
Primary
Number of Participatns With Adenosine Testing
Number of participants with adenosine testing
Time frame: At time of re-ablation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Radiofrequency Arm From FIRE AND ICE Trial | Number of Participatns With Adenosine Testing | 10 Participants |
| Cryoballoon Arm From FIRE AND ICE Trial | Number of Participatns With Adenosine Testing | 4 Participants |
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
Time frame: At time of re-ablation
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiofrequency Arm From 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 |
| Cryoballoon Arm From FIRE AND ICE Trial | Number of Pulmonary Veins Ablation - Ablation Lesion Sets Created During Re-ablation Procedure | 1.8 Pulmonary Veins ablated | Standard Deviation 1.4 |
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
Time frame: At time of re-ablation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiofrequency Arm From 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 |
| Cryoballoon Arm From FIRE AND ICE Trial | Number of Reconnected Pulmonary Veins as Documented in the Cath Lab / Imaging at the Time of Re-ablation Procedure | 1.4 Reconnected Pulmonary Veins | Standard Deviation 1.1 |
Primary
Percentage of Participants With Acute Procedural Success of Re-ablation Procedure
Summarize acute procedural success of re-ablation procedure per treatment arm
Time frame: At time of re-ablation
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiofrequency Arm From FIRE AND ICE Trial | Percentage of Participants With Acute Procedural Success of Re-ablation Procedure | 90.4 percentage of patients with acute succes |
| Cryoballoon Arm From FIRE AND ICE Trial | Percentage of Participants With Acute Procedural Success of Re-ablation Procedure | 93.9 percentage of patients with acute succes |
Primary
Re-ablation Procedure Times as Measured in the Cath Lab
Re-ablation procedure times as measured in the cath lab
Time frame: At time of re-ablation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiofrequency Arm From FIRE AND ICE Trial | Re-ablation Procedure Times as Measured in the Cath Lab | 122 minutes | Standard Deviation 53 |
| Cryoballoon Arm From FIRE AND ICE Trial | Re-ablation Procedure Times as Measured in the Cath Lab | 103 minutes | Standard Deviation 33 |