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Retrospective data collection on re-ablations performed within the FIRE AND ICE Trial.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No interventions - retrospective data collection | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 | At time of re-ablation |
| Number of Hospital Days for Re-ablation Procedure Form Admission to Discharge |
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N/A - no new patients will be enrolled within this project.
Inclusion Criteria for the FIRE AND ICE Trial included:
The exclusion criteria were grouped as follows in the FIRE AND ICE Trial:
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemocnice Na Homolce Praha | Prague | 15030 | Czechia | |||
| Clinique Pasteur Toulouse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31693319 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | At time of re-ablation |
|
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.
Not applicable. Safety reporting on all events was already performed as part of the original FIRE AND ICE Trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Project Manager (CSM) | Medtronic | 00491742122 | 081 | petra.kremer@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 20, 2017 | Jun 7, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 5, 2018 | Aug 13, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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 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 | Date of hospital discharge, assessed during the 36 month FU period |
| Number of Participatns With Adenosine Testing | Number of participants with adenosine testing | At time of re-ablation |
| Toulouse |
| 31076 |
| France |
| Herz-Zentrum Bad Krozingen | Bad Krozingen | 79189 | Germany |
| Cardioangiologisches Centrum Bethanien CCB | Frankfurt am Main | 60431 | Germany |
| Universitätsmedizin Greifswald | Greifswald | 17475 | Germany |
| Asklepios Klinik St. Georg Hamburg | Hamburg | 20099 | Germany |
| Herz-Zentrum Bodensee | Konstanz | 78464 | Germany |
| Isala Klinieken Zwolle | Zwolle | 8025 | Netherlands |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Clinico San Carlos Madrid | Madrid | 28040 | Spain |
| Hospital Clinico Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Clinico Universitario Valencia | Valencia | 46010 | Spain |
| Universitätsspital Basel | Basel | 4031 | Switzerland |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diagnosed with paroxysmal atrial fibrillation (PAF) [year] | Mean | Standard Deviation | years |
|
| BodyMassIndex (BMI) [kg/m^2] | Mean | Standard Deviation | kg/m^2 |
|
| Height [cm] | Mean | Standard Deviation | cm |
|
| Weight [kg] | Mean | Standard Deviation | kg |
|
| New York Heart Association (NYHA) Class | The New York Heart Association (NYHA) Functional Classification provides a way of classifying the extent of heart failure. NYHA I - No limiation of phyiscal activity. NYHA II - Slight limiation of phyiscial activity. NYHA III - Marked limiation of physical activity. NYHA IV - Unable to carry on any physical activity without discomfort. Within FIRE AND ICE Re-Do the majorty of patients 69% does not have heart failure signs. If any signs of heart failure documented in the baseline, then only mild forms. No heart failure patients (NYHA III or IV) were seen/enrolled in FIRE AND ICE Re-Do. | Count of Participants | Participants |
|
| Left Atrial Diameter (LAD) [mm] | Left Atrial Diameter was measured within the trial. An anteroposterior left atrial diameter of more than 55 mm as measured by trans-thoracic echocardiography is an exclusion criteria within the inital FIRE AND ICE Trial (outcome of ablation in patients with significant atrial dilation > 55 mm is lacking data but is seen as possible predictor for pulmonary vein isolation failure/atrial fibrillation recurrence). | Mean | Standard Deviation | mm |
|
| Left Ventricular Ejection Fraction (LVEF) [%] | The ejection fraction (EF) is a measurement, expressed as percentage, of how much blood the left ventricle pumps out with each contraction, e.g. an ejection fraction of 60% means that 60% of the total amount of blood in the left ventricle is pushed out with each heartbeat. Therefore the ejection fraction is an indcation of how well the heart is pumping and may be an evidence of heart failure (under 40%) or cardiomyopathy. | Mean | Standard Deviation | % |
|
| Left Ventricular End Diastolic Diameter (LVEDD) [mm] | Mean | Standard Deviation | mm |
|
| Left Atrium (LA) Volume [mL] | Mean | Standard Deviation | mL |
|
| Prior Direct Current Cardioversion (DCCV) | Number | participants |
|
| History of Atrial Flutter | Number | participants |
|
| Prior Stroke | Number | participants |
|
| Coronary Artery Disease (CAD) | Number | participants |
|
| Prior Myocardial Infarction (MI) | Number | participants |
|
| Aortic Valve Stenosis | Number | participants |
|
| Peripheral Artery Disease | Number | participants |
|
| Hyperlipidemia | Number | participants |
|
| Diabetes Type I or II | Number | participants |
|
| Hypertension | Number | participants |
|
| Prior Coronary Artery Bypass Graft (CABG) | Number | participants |
|
| Prior Percutaneous Coronary Intervention (PCI) | Number | participants |
|
| Antiarrhythmic Druc (AAD) at discharge | Number | participants |
|
| HATCH Score | The HATCH score stratifies patients with paroxysmal atrial fibrillation according to their risk for progression of sustained atrial fibrillation within 1-year. The HATCH score is an ordinal scale ranging from 0 to 7 points and is calculated based on the following formula: 1x (Hypertension) + 1 x (Age >75years) + 2 x (Transient Ischemic Attack or Stroke) + 1x (Chronic Obstructive Pulmonary Disease) + 2x (Heart Failure). Higher HATCH score is seen in literature as increased risk for progression of sustained atrial fibrillation. | Mean | Standard Deviation | units on a scale |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHG |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHG |
|
| Glomerular Filtration Rate (GFR) | Mean | Standard Deviation | mL/min/m2 |
|
| CHA2DS2-VASc | CHA2DS2-VASc Score for Atrial Fibrillation Stroke Risk. Score is between 0 and 9 points: 1 point - Congestive Heart Failure 1 point - Hypertension 2 point - Age > 75 years
1 point - Vascular Disease (prior myocardial infarction, peripheral artery disease, or aortic plaque) 1 point - Age 65 to 74 years 1 point - Sex category (i.e. female sex) A high score is the same as a higher stroke risk, and a low score means the lower stroke risk. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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 |
|
|
| 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 | Posted | Mean | Standard Deviation | Reconnected Pulmonary Veins | At time of re-ablation |
|
|
|
| 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 | Data were not collected; no standard documention and therfore not available in the reviewed medical files in the required detail | Posted | At time of re-ablation |
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | Pulmonary Veins ablated | At time of re-ablation |
|
|
|
| Primary | Percentage of Participants With Acute Procedural Success of Re-ablation Procedure | Summarize acute procedural success of re-ablation procedure per treatment arm | 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). | Posted | Number | percentage of patients with acute succes | At time of re-ablation |
|
|
|
| Primary | Re-ablation Procedure Times as Measured in the Cath Lab | Re-ablation procedure times as measured in the cath lab | Posted | Mean | Standard Deviation | minutes | At time of re-ablation |
|
|
|
| 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 | Posted | Mean | Standard Deviation | nights | From Date of Hospital admission until the date of hospital discharge up to 36 month FU period |
|
|
|
| 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 | Posted | Count of Participants | Participants | Date of hospital discharge, assessed during the 36 month FU period |
|
|
|
| Primary | Number of Participatns With Adenosine Testing | Number of participants with adenosine testing | Posted | Count of Participants | Participants | At time of re-ablation |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| NYHA Class II |
|
| NYHA Class not available |
|