FIRE AND ICE Re-Ablations: Retrospective Data Collection on Re-ablations Performed Within the FIRE AND ICE Trial
Conditions: Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Sponsor: Medtronic Cardiac Ablation Solutions

FIRE AND ICE – Re-Ablations (retrospective data collection) 
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Clinical Investigation Plan (CIP) 
Clinical Investigation Plan/Study Title  FIRE AND ICE – Re-Ablations (retrospective data collection) 
Study Product Name Retrospective Data Collection on re-ablations performed 
within the FIRE AND ICE Trial. 
Arctic Front® & Arctic Front Advance® Cardiac CryoAblation 
Catheter System (Cryo Arm) and NaviStar® ThermoCool® 
Ablation Catheter (Radiofrequency Arm) 
Sponsor/Local Sponsor Medtronic International Trading Sàrl 
Route du Molliau 31 
CH – 1131 Tolochenaz 
Document Version 1.0, 20 Sep 2017 
Global Principal Investigator Prof. Dr. Karl-Heinz Kuck 
Asklepios Klinik St. Georg 
Lohmühlenstr. 5 
D – 20099 Hamburg, Germany 
Scientific Coordinating Investigator Dr. Alexander Fürnkranz 
Universitätsklinikum Düsseldorf 
Moorenstr. 5 
D – 40225 Düsseldorf 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of Medtronic. 
Any distribution, copying, or disclosure without the prior written authorization of Medtronic is strictly 
prohibited. Persons to whom the information is disclosed must know that it is confidential and that it 
may not be further disclosed by them. 
 
 

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1. Investigator Statement 
Study product Name 
Retrospective Data Collection on re-ablations performed 
within the FIRE AND ICE Trial. 
Arctic 
Front® 
& 
Arctic 
Front 
Advance® 
Cardiac 
CryoAblation Catheter System (Cryo Arm) or NaviStar® 
ThermoCool® Ablation Catheter (Radiofrequency Arm) 
Sponsor 
Medtronic International Trading Sàrl 
Route du Molliau 31 
CH – 1131 Tolochenaz 
Version Number/Date  
Version 1.0, 20 Sep 2017 
I have read the clinical investigation plan, including all appendices as applicable, and I agree that it 
contains all necessary details for me and my staff to conduct this retrospective data collection as 
described. I will conduct this retrospective data collection as outlined herein and will make a reasonable 
effort to complete the retrospective data collection within the time designated. 
I agree to comply with the International Conference on Harmonization Guidelines on Good Clinical 
Practice, the ethical principles that have their origin in the Declaration of Helsinki (18th World Medical 
Assembly Helsinki 1964) and all applicable amendments laid down by the World Medical Assemblies and 
the Data Protection Directive (95/46/EC). I agree to ensure that the confidential information contained 
in this document will not be used for any purpose other than the evaluation and conduct of the clinical 
investigation/retrospective data collection without the prior written consent of Medtronic. 
I will provide all study personnel under my supervision copies of the clinical investigation plan and 
access to all information provided by Medtronic. I will discuss this material with them to ensure that 
they are fully informed about the content of this retrospective data collection. 
Investigator’s Signature: 
 
 
Investigator’s Name: 
 
 
Institution: 
 
 
Date:  
 
 
 
 

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Table of Contents  
 
1. 
Investigator Statement ...................................................................................................... 2 
Table of Contents ...................................................................................................................... 3 
2. 
Glossary .............................................................................................................................. 6 
Sponsor Contact Information ........................................................................................................... 7 
CRO Contact Information ................................................................................................................. 7 
3. 
Synopsis ............................................................................................................................. 8 
4. 
Introduction ..................................................................................................................... 10 
4.1. Background ........................................................................................................................... 10 
4.2. Purpose ................................................................................................................................. 10 
5. 
Data to be collected ......................................................................................................... 11 
6. 
Objectives and Endpoints ................................................................................................. 12 
6.1. Objectives and Endpoints ....................................................................................................... 12 
6.1.1. 
Objective: Atrial arrhythmias prior to re-ablation ................................................................ 12 
6.1.2. 
Objective: Reconnected pulmonary veins ............................................................................ 13 
6.1.3. 
Objective: Number and location of gaps in pulmonary vein ablation lesions ...................... 13 
6.1.4. 
Objective: Ablation lesion sets performed............................................................................ 14 
6.1.5. 
Objective: Acute procedural success .................................................................................... 14 
6.1.6. 
Objective: Re-ablation procedure times ............................................................................... 15 
6.1.7. 
Objective: Re-ablation hospitalization length of stay ........................................................... 15 
6.1.8. 
Objective: Anti-arrhythmic drug use at re-ablation hospitalization discharge ..................... 15 
6.1.9. 
Objective: Summarize adenosine testing .............................................................................. 15 
7. 
Study Design .................................................................................................................... 16 
7.1. Duration ................................................................................................................................ 16 
7.2. Rationale ............................................................................................................................... 16 
8. 
Product Description (N/A) ............................................................................................... 16 
9. 
Selection of Subjects ........................................................................................................ 16 
9.1. Study Population .................................................................................................................... 16 
9.2. Subject Enrollment (N/A) ........................................................................................................ 17 

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9.3. Inclusion Criteria (N/A) ........................................................................................................... 17 
9.4. Exclusion Criteria (N/A) .......................................................................................................... 17 
10. Study Procedures ............................................................................................................. 17 
10.1. 
Schedule of Events (N/A) .................................................................................................. 17 
10.2. 
Subject Screening (N/A) ................................................................................................... 17 
10.3. 
Prior and Concomitant Medications (N/A) ........................................................................... 17 
10.4. 
Subject Consent (Data Release Form) ................................................................................ 18 
10.5. 
Randomization and Treatment Assignment (N/A) ............................................................... 19 
10.6. 
Medication Compliance (N/A) ............................................................................................ 19 
10.7. 
Assessment of Efficacy ..................................................................................................... 19 
10.8. 
Assessment of Safety (N/A) .............................................................................................. 19 
10.9. 
Recording Data ................................................................................................................ 19 
10.10. 
Deviation Handling ........................................................................................................... 21 
10.11. 
Subject Withdrawal or Discontinuation ............................................................................... 21 
11. Risks and Benefits ............................................................................................................ 22 
11.1. 
Potential Risks .................................................................................................................. 22 
11.2. 
Potential Benefits ............................................................................................................. 22 
11.3. 
Risk-Benefit Rationale ....................................................................................................... 22 
12. Data Review Committees ................................................................................................. 22 
13. Statistical Design and Methods ........................................................................................ 23 
13.1. 
General Considerations ..................................................................................................... 23 
13.2. 
Analysis Timing ................................................................................................................ 23 
13.3. 
Objectives ........................................................................................................................ 23 
13.3.1. 
Objective #1: Atrial arrhythmias prior to re-ablation ........................................................ 23 
13.3.2. 
Objective #2: Reconnected pulmonary veins .................................................................... 24 
13.3.3. 
Objective #3: Number and location of gaps in pulmonary vein ablation lesions .............. 24 
13.3.4. 
Objective #4: Ablation lesion sets performed ................................................................... 25 
13.3.5. 
Objective #5: Acute procedural success ............................................................................ 26 
13.3.6. 
Objective #6: Re-ablation procedure times ....................................................................... 27 
13.3.7. 
Objective #7: Hospitalization length of stay ...................................................................... 27 
13.3.8. 
Objective #8: Anti-arrhythmic drug use at discharge ........................................................ 28 

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13.3.9. 
Objective #9: Adenosine testing ........................................................................................ 28 
14. Ethics ................................................................................................................................ 28 
14.1. 
Statement(s) of Compliance .............................................................................................. 28 
15. Study Administration ....................................................................................................... 29 
15.1. 
Monitoring ....................................................................................................................... 29 
15.2. 
Data Management ............................................................................................................ 30 
15.3. 
Direct Access to Source Data/Documents ........................................................................... 30 
15.4. 
Confidentiality .................................................................................................................. 31 
15.5. 
Liability (N/A) ................................................................................................................... 31 
15.6. 
CIP Amendments ............................................................................................................. 32 
15.7. 
Record Retention ............................................................................................................. 32 
15.8. 
Publication and Use of Information .................................................................................... 33 
15.9. 
Suspension or Early Termination ....................................................................................... 34 
16. References ....................................................................................................................... 36 
5. 
Appendices ....................................................................................................................... 36 
6. 
Version History ................................................................................................................. 36 
Appendix I – List of Participating Countries ..................................................................................... 37 
Appendix II – List of Participating Clinical Sites and Investigators ..................................................... 38 
Appendix III – Data Release Form (Master Version) ........................................................................ 40 
INFORMATION SHEET ......................................................................................................................... 40 
SIGNATURE SHEET ............................................................................................................................... 42 
Appendix IV – Members of Endpoint Review Committee (ERC) ......................................................... 45 
Appendix V – Members of Publication Committee ............................................................................ 46 
 
 
 

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2. Glossary 
Term 
Definition 
AAD 
Antiarrhythmic drugs 
AF 
Atrial fibrillation 
CIP 
Clinical Investigation Plan 
COV 
Close Out Visit 
CRA 
Clinical Research Associate 
CRO 
Contract Research Organization 
CTA 
Clinical Trial Agreement 
DRF 
Data Release Form 
EC 
Ethics Committee 
ECG 
Electrocardiography 
eCRF 
Electronic Case Report Form 
ERC 
Endpoint Review Committee 
GCP 
Good Clinical Practice 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IRB 
Institutional Review Board 
LA 
Left atrium 
PAF 
Paroxysmal atrial fibrillation 
PI 
Principal Investigator 
PV 
Pulmonary Vein 
Re-Do (redo) 
Re-Ablation / Re-Ablation procedure 
RF 
Radiofrequency 
RFC 
Radiofrequency current 
SC 
Steering Committee 
SDV 
Source Data Verification 
SIV 
Site Initiation Visit 

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Sponsor Contact Information 
Medtronic contact information is provided below. This information is subject to change during the 
course of the project. Updates to the contact information will be sent to the sites and committees as 
needed. 
Table 2-1: Sponsor contact information 
Sponsor Contact 
EU Sponsor Contact 
Dr. Ralf Meyer, Director Clinical Research 
Medtronic International Trading Sàrl 
Route du Molliau 31 
CH – 1131 Tolochenaz  
ralf.meyer@medtronic.com 
+49 175 581 0431 
Clinical Study Leader 
Petra Kremer, Pr. Clinical Research Specialist 
Medtronic GmbH 
Earl-Bakken-Platz 1 
Meerbusch, Germany 40670 
petra.Kremer@medtronic.com 
+49 174 212 2081 
CRO Contact Information 
Contract Research Organization (CRO) contact information is provided below in Table 2-2. Up to date 
CRO contact information will be provided to all participating sites within the Investigator Site File (ISF) / 
Regulatory Binder. 
Table 2-2: CRO contact information 
Contact Information 
Duties Performed 
CRO 
genae associates nv 
Global Headquarters 
Justitiestraat 6B 
2018 Antwerp, Belgium 
+32 3 290 03 06 
The CRO will direct and coordinate the clinical 
project. Responsibilities include, but are not 
limited to, monitoring clinical sites, coordinating 
data collection, including eCRF/database support, 
and assisting in maintaining compliance to 
regulations. 
 
 

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3. Synopsis 
Title 
FIRE AND ICE – Re-Ablations (retrospective data collection) 
Clinical Study Type 
Retrospective Data Collection on re-ablations performed within the 
FIRE AND ICE Trial. 
Product Name 
Products Used within the FIRE AND ICE Trial: Arctic Front® & Arctic 
Front Advance® Cardiac CryoAblation Catheter System (Cryo Arm; 
Manufacturer Medtronic, Inc; model number 2AF233 and 2AF283) and 
NaviStar® ThermoCool® Ablation Catheter (Radiofrequency Arm; 
Manufacturer Biosense Webster, Inc.) 
Sponsor 
Medtronic International Trading Sàrl 
Route du Molliau 31 
CH – 1131 Tolochenaz 
Indication under 
investigation  
The proposed indication for the Arctic Front Advance® Cardiac 
CryoAblation Catheter System is as follows: The Arctic Front Advance® 
Cardiac CryoAblation Catheters are indicated for the treatment of drug 
refractory recurrent symptomatic paroxysmal and persistent atrial 
fibrillation (AF). 
The proposed indications are within the approved indications in Europe 
for all involved catheter systems. 
Investigation Purpose 
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 
(AF). 
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. The resulting data may 
provide insight into the possible causes for re-occurrence of atrial 
arrhythmias requiring re-ablation. 
Product Status 
Retrospective Data Collection only on re-ablations performed within 

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the FIRE AND ICE Trial (marked products). 
Objective(s) and Endpoints 
• 
Summarize the documented atrial arrhythmias prior to re-
ablation  
• 
Summarize the number of reconnected pulmonary veins 
• 
Summarize the number of gaps and location of gaps present in 
pulmonary vein ablation lesions 
• 
Summarize ablation lesion sets created during re-ablation 
procedure 
• 
Summarize acute procedural success of re-ablation procedure 
• 
Summarize re-ablation procedure times. 
• 
Summarize the length of stay during the hospitalization for re-
ablation 
• 
Summarize the anti-arrhythmic drug use at time of discharge 
from the re-ablation procedure. 
• 
Summarize adenosine testing 
Study Design 
Retrospective Data Collection on re-ablations performed within the 
FIRE AND ICE Trial. No change in the subject population or participating 
sites. It is estimated to collect the additional retrospective data on re-
ablations within 2 months. 
Randomization 
Not applicable. 
Sample Size 
No new subjects will be enrolled. In total 119 re-ablations were 
performed in the FIRE AND ICE Trial. These applicable subjects will be 
now asked for their consent for the additional data collection on re-
ablation procedures. 
Inclusion/Exclusion Criteria 
Not applicable. 
Study Procedures and 
Assessments 
Not applicable. Only data of already performed procedures will be 
collected. 
Safety Assessments 
Not applicable. Safety reporting on all events was already performed as 
part of the FIRE AND ICE Trial. 
Statistics 
A total of 119 repeat ablations were reported in 110 subjects in the 
FIRE AND ICE trial.  The primary analysis cohort for this CIP will be 
subjects that provide informed consent for a retrospective data 
collection (if required by local law / EC). 
One final analysis will be completed.  Data from all consented subjects 
will be entered into the project database.  At the completion of the 
review by the endpoint review committee, the endpoint review 
committee classifications will be entered into the database and the 
database will be frozen. 
Nine objectives are defined for this CIP as listed above. 

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4. Introduction  
4.1. Background  
The FIRE AND ICE Trial was a controlled, prospective, non-inferiority, parallel-group, randomized, 
interventional, open, blinded outcome assessment (PROBE-Design), multi-centre trial, comparing 
efficacy and safety of isolation of the pulmonary veins with a Cryoballoon catheter versus a 
Radiofrequency ablation with a ThermoCool® catheter in subjects with paroxysmal atrial fibrillation1. 
A total of 762 subjects underwent randomization within the FIRE AND ICE Trial: 378 assigned to 
cryoballoon ablation and 384 assigned to radiofrequency ablation. The mean duration of follow-up was 
1.5 years. The primary efficacy endpoint (time to first documented recurrent atrial arrhythmia defined 
as AF>30s, AT or AFL, AAD prescription or repeat ablation) was reached in 138 subjects in the 
cryoballoon group and in 143 in the radiofrequency group and the related data published in the New 
England Journal of Medicine on April 4, 20162. The primary efficacy endpoint was observed to occur at 
similar rate in the cryoballoon and radiofrequency arms (1-year Kaplan–Meier event rate estimates, 
34.6% and 35.9%, respectively; hazard ratio, 0.96; 95% confidence interval [CI], 0.76 to 1.22; P<0.001 for 
noninferiority). The secondary analyses on reintervention and rehospitalization showed that subjects 
treated with cryoballoon as opposed to radiofrequency current (RFC) ablation had significantly fewer 
repeat ablations (11.8% cryoballoon vs. 17.6% RFC; p=0.03), direct-current cardioversions (3.2% 
cryoballoon vs. 6.4% RFC; p=0.04), all-cause hospitalizations (32.6% cryoballoon vs. 41.5% RFC; p=0.01), 
and cardiovascular rehospitalizations (23.8% cryoballoon vs. 35.9% RFC; P=0.01) during follow-up. 
Additionally, both subject groups (Cryo and RF arm) improved in quality-of-life scores after AF ablation3. 
After the first ablation procedure, in total 119 re-ablations at 15 sites were performed, thereof 49 in the 
Cryo arm and 70 in the RF arm.  The frequency of re-ablation procedures and energy modality of 
catheter used during the re-ablation was collected during the FIRE AND ICE Trial, but limited data 
surrounding the re-ablation procedures were collected. 
4.2. Purpose 
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. The resulting data may provide 
insight into the possible causes for re-occurrence of atrial arrhythmias requiring re-ablation. 

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5. Data to be collected 
Administrative Information 
• 
Data Release Form process 
• 
Subject status 
• 
Randomization group assigned within FIRE AND ICE including date of index ablation 
Additional data on index ablation 
• 
Data on non-pulmonary vein lesions made 
• 
Cryo Arm (per PV): number of freezes, minimum temperature, duration per freeze, time to 
effect of freeze, bonus freeze and freeze duration / bonus freeze based on TTE 
• 
RF Arm (per PV): power (watt) minimum, power (watt) maximum, smart touch force 
measurements (g) minimum, smart touch force measurements (g) maximum and complete RF 
time (for one side) 
Subject characteristics at time of re-ablation and indication for re-ablation 
• 
Date of hospital admission for re-ablation 
• 
Indication for repeat ablation (including symptoms and way of arrhythmia recurrence 
documentation) 
• 
PV anatomy / stenosis 
• 
Recovered conduction gaps, including localization of gaps and differentiation of gaps (spot gap 
or linear gap) 
• 
Vein isolation summary pre-ablation / results of PV mapping 
• 
Ablation strategy on PVs chronically isolated 
• 
Membrane-active AADs at time of re-ablation and at discharge after re-ablation 
• 
Anticoagulation at time of re-ablation 
• 
Adenosine use 
Procedure parameters 
• 
Rhythm at start of procedure ECG 
• 
Catheters used to perform lesions / energy source used for re-ablation 
• 
Visualization / navigational tools used 
• 
Methods for determining balloon occlusion (Cryo) 
• 
Phrenic nerve monitoring (Cryo Arm) 
• 
Ablation lesions performed 
• 
Cryo Arm (per PV): number of freezes, minimum temperature, duration per freeze, time to 
effect of freeze and bonus freeze 
• 
RF Arm (per PV): power (watt) minimum, power (watt) maximum, smart touch force 
measurements (g) minimum, smart touch force measurements (g) maximum and complete RF 
time (for one side) 
• 
Other lesion sets beyond PVI 
 
 

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Procedure times & procedure summary 
• 
Total procedure times 
• 
Fluoroscopy times and dosage 
• 
LA dwell time 
• 
3D mapping time 
• 
ACT time (lowest / highest) 
• 
Sedation type 
• 
Cryo Arm: only Arctic Front Advance catheters used / duration of freezes less than planned 
• 
Phrenic nerve injury 
• 
Cardioversion during procedure 
Results of re-ablation & discharge 
• 
Success / all targeted PVs isolated / outcome other lesion sets beyond PVI 
• 
Rhythm(s) at end of procedure 
• 
Date of discharge and discharge status (including prolonged hospitalization) 
• 
Re-occurrence of arrhythmia during hospital stay 
• 
Cardioversion after re-ablation due to early AT/AF recurrence 
• 
Membrane-active AADs at time of discharge 
6. Objectives and Endpoints 
6.1. Objectives and Endpoints 
Rationale for study endpoints 
Study endpoints have been chosen based on the 2012 HRS/EHRA/ECAS Expert Consensus Statement on 
Catheter and Surgical Ablation of Atrial Fibrillation4. Definitions, mechanisms, and treatment strategies 
for atrial arrhythmias are outlined in the expert consensus statement.  The objectives and endpoints of 
this data collection reflect these definitions, mechanisms, and treatment strategies. Hospitalization may 
be the result of a procedural complication, and therefore has been included as an endpoint in this CIP. 
6.1.1. 
Objective: Atrial arrhythmias prior to re-ablation 
Summarize the documented atrial arrhythmias prior to re-ablation 
Endpoint: Each documented atrial arrhythmia will be classified into one of the following categories: 
• 
Atrial Fibrillation 
o Paroxysmal 
o Persistent 
• 
Atrial Tachycardia 
• 
Atrial Flutter 
o Typical 
o Atypical 

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6.1.2. 
Objective: Reconnected pulmonary veins 
Summarize the number of reconnected pulmonary veins 
Endpoint: Each pulmonary vein will be classified as electrically isolated or not prior to re-ablation.  
Electrically isolated is defined as bi-directional block, entrance and exit block of PV potentials. 
6.1.3. 
Objective: Number and location of gaps in pulmonary vein ablation lesions 
Summarize the number of gaps and location of gaps present in pulmonary vein ablation lesions 
Endpoint: For a redo conducted with a focal catheter and 3D EA mapping, a gap within the pulmonary 
vein ablation lesion is defined as an electrically reconnected pulmonary vein which after a single spot re-
ablation the response to re-ablation is either PV re-isolation or PV activation-sequence change. Ongoing 
PV conduction after a single spot re-ablation is attributed to an additional gap. Additional gaps are 
defined similarly. 
For a redo conducted with no 3D EA Mapping, gap location may have been estimated utilizing a mapping 
catheter. 
Each gap location will be identified by the classifications provided in Error! Not a valid bookmark self-
reference.. To define the location of a gap, including the differentiation for spot gap or linear gap the 
ipsilateral LA-PV junction is divided into 6 equally distributed segments; superior, antero-superior, 
antero-inferior, inferior, postero-inferior, and postero-superior. 
Spot gap is defined as millimeter size, requiring only a single application without moving the catheter. 
Linear gap (larger continuous gap) is defined by requiring multiple applications or drawing of the 
catheter. 
Figure 1: Pulmonary Vein Gap Locations 

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6.1.4. 
Objective: Ablation lesion sets performed 
Summarize ablation lesion sets created during re-ablation procedure. 
Endpoint: Each lesion set during re-ablation will be classified into one of the following categories: 
• 
Pulmonary vein isolation (PVI) 
• 
LA AF Trigger 
• 
RA AF Trigger 
• 
Superior vena cava trigger 
• 
Inferior vena cava trigger 
• 
Cavotricuspid Isthmus (CTI) 
• 
Mitral valve isthmus or line 
• 
Left sided roofline 
• 
Complex fractionated atrial electrogram (CFAE) 
• 
Posterior wall 
• 
AVNRT ablation 
• 
other 
6.1.5. 
Objective: Acute procedural success  
Summarize acute procedural success as assessed by the sites 
Endpoint: Definition of success for each lesion set found below 
• 
Pulmonary vein isolation (PVI) 
o Acute failure is defined as inability to isolate the pulmonary vein (minimally assessed for 
entrance block and, where assessable, exit block). Acute success is defined as the 
absence of acute failure. 
• 
LA AF Trigger 
o Acute success is defined as elimination of trigger by ablation procedure. 
• 
RA AF Trigger 
o Acute success is defined as elimination of trigger by ablation procedure. 
• 
Superior vena cava trigger 
o Acute success is defined as elimination of trigger by ablation procedure. 
• 
Inferior vena cava trigger 
o Acute success is defined as elimination of trigger by ablation procedure. 
• 
Cavotricuspid Isthmus (CTI) 

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o Acute success is defined as bidirectional conduction block at the CTI line 
• 
Mitral valve isthmus ablation 
o Acute success is defined as bidirectional conduction block at the mitral isthmus line 
• 
Left atrial roofline 
o Acute success is defined as confirmed block at the roof line 
• 
Left atrial posterior wall 
o Acute success is defined as confirmed block at the posterior wall 
• 
Complex fractionated atrial electrogram (CFAE) 
o Acute success is defined when ablation of electrograms resulted in termination of atrial 
fibrillation to sinus rhythm or until all complex fractionated regions were completely 
eliminated 
• 
AVNRT ablation 
o Acute success is defined as 1) no AVNRT inducibility; 2) no jump; 3) single echo only. 
• 
Other 
6.1.6. 
Objective: Re-ablation procedure times 
Summarize re-ablation procedure times. 
Endpoint: 
1. Total procedure time is defined as time from first venous access to time of last sheath removal. 
2. Left atrial dwell time is defined as time from transseptal puncture to time of removal of last 
sheath from the left atrium. 
3. Fluoroscopy time is defined as total fluoroscopy time used during the procedure. 
6.1.7. 
Objective: Re-ablation hospitalization length of stay 
Summarize the length of stay during the hospitalization for re-ablation 
Endpoint: Length of stay is defined as the number of days from admission to discharge. 
6.1.8. 
Objective: Anti-arrhythmic drug use at re-ablation hospitalization 
discharge 
Summarize the anti-arrhythmic drug use at time of discharge from the re-ablation procedure. 
Endpoint: Anti-arrhythmic drug is defined as a Class I or III antiarrhythmic drug 
6.1.9. 
Objective: Summarize adenosine testing 
Summarize adenosine testing 
Endpoint: Adenosine testing utilized at the time of re-ablation. 

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7. Study Design  
Additional retrospective data collection on data of the performed re-ablations (procedural data) within 
the FIRE AND ICE Trial in both treatment arms. 
The FIRE AND ICE Trial was an investigator initiated, controlled, prospective, non-inferiority, parallel-
group, randomized, interventional, open, blinded outcome assessment (PROBE-Design), multi-center 
trial, comparing efficacy and safety of isolation of the pulmonary veins with a Cryoballoon catheter 
versus a Radiofrequency ablation with a ThermoCool® catheter in subjects with paroxysmal atrial 
fibrillation21. 
7.1. Duration 
The duration of the data collection for this project is expected to be 2 months, from initiation of first 
site, data collection, and closing of final site. No subject follow-up is required as the project is 
retrospective data collection only. 
7.2. Rationale 
Additional procedural re-ablation data will be collected retrospectively of all enrolled FIRE AND ICE 
subjects who had a re-ablation procedure during the follow-up period. 
Within the FIRE AND ICE Trial, the occurrence of a re-ablation procedure, and the energy modality 
utilized during the procedure (Cryo or RF) were documented, but limited details on the performed re-
ablation procedure were captured. Having additional data surrounding the re-ablation procedures may 
provide insight into the re-occurrence of atrial arrhythmias resulting in a re-ablation procedure.  
8. Product Description (N/A) 
Retrospective data collection only. No new assessments will be made nor any products used within this 
project. 
9. Selection of Subjects 
9.1. Study Population 
No new subjects will be enrolled. Subject population enrolled in the related FIRE AND ICE Trial had drug 
refractory symptomatic paroxysmal atrial fibrillation with at least two episodes in the last three months 
prior to the trial enrollment and at least one episode documented. In addition, documented treatment 

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failure of at least one AAD Type I or III, excluding beta-blocker and AAD intolerance and an age range 
between 18 and 75 years. 
9.2. Subject Enrollment (N/A) 
Retrospective data collection only. No new subjects will be enrolled under this CIP. 
Prior to any entry of retrospective subject data into the project database, the subject has to sign and 
date the Data Release Form. A subject is considered as “active subject” within this project at the time 
the Data Release Form has been fully signed and dated. 
The medical files (subject records) at the participating site should indicate that the subject is an active 
subject within the retrospective data collection. 
9.3. Inclusion Criteria (N/A) 
No new subjects will be enrolled under this CIP. All subjects of whom the additional re-ablation data will 
be collected are enrollment and valid subjects within the FIRE AND ICE Trial. 
9.4. Exclusion Criteria (N/A) 
Not applicable. All subjects of whom the additional re-ablation data will be collected are enrollment and 
valid subjects within the FIRE AND ICE Trial. 
10. Study Procedures 
No study procedures will be performed under this CIP. Retrospective data will be collected on 
performed re-ablations occurred during the FIRE AND ICE follow-up period. 
10.1. Schedule of Events (N/A) 
Retrospective data collection only. Data on performed re-ablation procedures will be collected that 
were performed during the follow-up period of the FIRE AND ICE Trial. 
10.2. Subject Screening (N/A) 
No applicable – no new subjects will be screened or enrolled under this CIP. 
10.3. Prior and Concomitant Medications (N/A) 
Not applicable as retrospective data collection only. 

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10.4. Subject Consent (Data Release Form) 
A signed and personally dated by the investigator or authorized designee and subject, sponsor and 
ethics committee (EC) / institutional review board (IRB) approved data release form, written in 
accordance with the country-specific applicable data privacy acts and the Data Protection Directive 
(95/46/EC), will be obtained from every subject who had a re-ablation procedure within the FIRE AND 
ICE Trial prior to the collection of any additional data (if required). Ethical principles as laid down by the 
Declaration of Helsinki (18th World Medical Assembly, Helsinki 1964) and all applicable amendments laid 
down by the World Medical Assemblies have been considered for the data release form as well as for 
the subject consenting process. 
The process of obtaining subject data release form by the principal investigator or his/her authorized 
designee shall: 
• 
Not waive or appear to waive subject’s legal rights 
• 
Use language that is non-technical and understandable to the subject 
• 
Provide ample time for the subject to read and understand the data release form and to ask 
questions, receive answers and consider participation 
• 
Avoid any coercion or undue improper influence on, or inducement of, the subject to 
participate in the project 
The sponsor should avoid improper influence on, or inducement of, the subject, monitor, any 
investigator(s) or other parties participating in, or contributing to, the retrospective data collection 
project. 
For deceased subjects, in accordance with the country-specific data privacy acts and as approved by the 
applicable IRB/EC, a relative or legally authorized representative can sign the data release form to 
collect additional retrospective data as documented in the subject charts. Local IRB/EC procedures must 
be followed here. 
The refusal of a subject (as applicable relative or legally authorized representative) to sign the data 
release form and therefore not agreeing to the collection of additional retrospective data must never 
interfere with the subject-physician relationship or future subject treatment. 
Should there be any change to this CIP, directly affecting the data privacy of the subject, a modification 
of the data release form is required. The data release form needs to be signed and personally dated by 
the investigator or authorized designee and the subject or relative/legally authorized representative (re-
consenting if required) after approval by the sponsor and the IRB/EC. 
A copy of the fully executed data release form (if required) must be provided to the subject (as 
applicable to the relative or legally authorized representative) and the original maintained in the trial 
files / subject files. 

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10.5. Randomization and Treatment Assignment (N/A) 
Not applicable as retrospective data collection only. 
Within the FIRE AND ICE Trial the subjects were randomized into two parallel trial groups, namely “Cryo” 
and “RF”. Randomization was stratified by an age-limit of 65 years, providing the same numbers of 
treatment assignments per group in both age-cohorts (≤ 65 years versus > 65 years). 
10.6. Medication Compliance (N/A) 
Not applicable as retrospective data collection only – no medication intake. 
10.7. Assessment of Efficacy 
Objectives are defined in section 6.1 for this retrospective data collection. 
10.8. Assessment of Safety (N/A) 
Not applicable. No new safety data will be collected within this retrospective data collection. 
Primary and secondary safety outcome parameter as defined in the FIRE AND ICE Trial CIP were assessed 
and analyzed accordingly. No additional safety analyses are planned based on the retrospectively 
collected data on re-ablations procedures. 
All devices used in the FIRE AND ICE Trial are marked released. Therefore, Post Marked Surveillance is 
applicable. The additional procedural data collected within this retrospective data collection will be 
reviewed for potential product complaints per the project Clinical Safety Management and Potential 
Complaint Plan and Vigilance reporting to Competent Authorities, if required. 
A product complaint is defined as any written, electronic or oral communication that alleges deficiencies 
related to the identity, quality, durability, reliability, safety, effectiveness or performance of a device 
that has been placed on the market. 
10.9. Recording Data 
All data obtained in the context of this retrospective data collection are subject of data protection. This 
applies to subjects’ data as well as to investigators’ personal data which may be included in any 
database of Medtronic or the contract research organization (CRO). 
The investigators shall take care that any subject documents (e.g. copies of reports or ECGs) transmitted 
to the database, specific lab or Medtronic contain no names, but only the year of birth and relevant 

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subject number as generated and assigned to the subject within the FIRE AND ICE Trial (the same 
numeric identifiers will be used). 
All medical data collected within this retrospective data collection will be recorded directly into the 
eCRFs. Documentation on paper will be restricted to exceptional circumstances only. 
It is within the responsibility of the investigator to confirm completeness and correctness of the data 
entered into the eCRF by signing-off the eCRF (electronic signature). 
The data entry into the eCRF will be done by the participating sites. The investigator must ensure to 
provide the accurate and complete source documents in a timely manner. 
Source data are defined as all information in original records and certified copies of original records of 
clinical findings, observations or other activities. Source data are contained in source documents 
(original records or certified copies). 
Source documents are defined as original documents, data and records (e.g. hospital records, clinical 
and office charts, electronic subject records, laboratory notes, memoranda, subject diaries or evaluation 
check lists, pharmacy dispensing records, recorded data from automated instruments, copies or 
transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, 
microfilm or magnetic media, x-rays, subject files, records kept at pharmacy, at the laboratories and the 
medico technical departments) as involved in this retrospective data collection. 
As this is a retrospective data collection only, eCRF cannot be a source document. 
 
 

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10.10. 
Deviation Handling 
The investigator is not allowed to deviate from the CIP. Any deviation to this CIP must be reported in the 
eCRF regardless of medically justifiable, pre-approved by sponsor (or delegate), an inadvertent 
occurrence, or taken to protect the subject in an emergency.  
A deviation is defined as an event in the project that did not occur according to the CIP or Clinical Trial 
Agreement (CTA), e.g. deviation in the EC / IRB or Data Release Form process. Prior approval by sponsor 
(or delegate) is expected in situations where the investigator anticipates, contemplates, or makes a 
conscious decision to deviate.  Prior approval is not required when a deviation is necessary to protect 
the safety, rights or well-being of a subject in an emergency or in unforeseen situations beyond the 
investigator’s control (e.g. inadvertent loss of data due to computer malfunction). 
The following data will be collected in the eCRF for deviations: 
• 
Date of deviation 
• 
Visit/template associated with deviation 
• 
Deviation description 
• 
Deviation pre-approved 
• 
Deviation coding 
Report of CIP deviations to the EC / IRB should comply with EC / IRB policies and must be reported to the 
sponsor (or delegate) as soon as possible upon the participating site becoming aware of the deviation. 
Sponsor (or delegate) is responsible for analyzing deviations, assessing their significance, and identifying 
any additional corrective and/or preventive actions (e.g. amend the CIP, conduct additional training or 
terminate the project). Repetitive or serious investigator compliance issues may result in initiation of a 
corrective action plan with the investigator and the site, and in some cases, necessitate suspending data 
entry until the problem is resolved or ultimately terminating the investigator’s participation in the 
project. 
The investigator will propose any appropriate modification(s) of the CIP. Medtronic will review this 
proposal and decide whether the modification(s) will be implemented. 
10.11. 
Subject Withdrawal or Discontinuation  
All subjects who had a re-ablation procedure during the follow-up period of the FIRE AND ICE Trial will 
be asked for their consent to collect the additional retrospective data on the re-ablation procedure. In 
case a subject withdraw his/her consent for the retrospective data collection after signing the data 
release form, the withdrawal will be documented with data and reason as applicable. All retrospective 
data entered in the eCRF by the time of the withdrawal will be used for assessments if not explicitly 
requested different by the subject. The subjects will be advised within the data release form about their 

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right to withdraw from the retrospective data collection at any time without statement of reasons and 
without reprisal. 
As there is no follow-up defined for this CIP, there is no impact for withdrawn subjects. Also, as no new 
subjects will be enrolled under this CIP, replacement of withdrawn subjects is not applicable. 
11. Risks and Benefits 
11.1. Potential Risks 
Retrospective data collection. No direct subject involvement and therefore also no potential risks for the 
subjects. All primary endpoint data were already collected within the FIRE AND ICE Trial. No potential 
risks regarding the overall outcomes. 
11.2. Potential Benefits 
There is no direct benefit for the subject but the additional collected data may help to improve the 
future treatment of AF subjects. 
11.3. Risk-Benefit Rationale 
Retrospective data collection only. No direct benefit for the subject is expected but also no risk for the 
subject. 
The additional collected data on the performed re-ablation procedures may help to understand the 
outcomes after ablations better, as well as on re-occurrence of AF. Both parts may help to improve 
future treatment of subjects with AF. 
12. Data Review Committees 
The same Endpoint Review Committee (ERC) will be used under this CIP as for the FIRE AND ICE Trial. 
There will be three assigned members of the ERC as listed in Appendix IV who are experienced 
clinicians, not related to the project and will be blinded to the therapy group. 
The ERC members will centrally review and adjudicate the collected data on re-ablations, e.g. gap 
assessment, ablation type performed, and re-ablation success as required. 
The Lead Principal Investigator as well as the Scientific Coordinating Investigator will provide advice on 
the scientific and clinical aspects of the CIP and related documents, as well as scientific and clinical 

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advice on the execution and scientific reporting of the retrospective data collection. No additional 
Steering Committee will be involved under this CIP. 
No DSMB will be involved in this project as no safety data will be collected in addition under this CIP. 
13. Statistical Design and Methods 
13.1. General Considerations 
A total of 119 repeat ablations were reported in 110 subjects in the FIRE AND ICE Trial.  The primary 
analysis cohort for this CIP will be subjects that provide informed consent for a retrospective data 
collection (as required).  Of the 110 subjects with re-ablations during the FIRE AND ICE Trial, only those 
that consent for retrospective data collection will be included in analyses (as required by local law / EC).  
The Statistical Analysis Plan (SAP) will be created prior to data analysis and include a comprehensive 
description of the statistical methods to be included in study reports. Any change to the data analysis 
methods described in the CIP will require an amendment only if it changes a principal feature of the CIP. 
Any other change to the data analysis methods described in the CIP, and the justification for making the 
change, will be described in the clinical study report. Medtronic employees or their designated 
representatives will perform all statistical analyses. 
13.2. Analysis Timing 
One final analysis will be completed.  Data from all consented subjects will be entered into the project 
database.  At the completion of the review by the endpoint review committee, the endpoint review 
committee classifications will be entered into the database and the database will be frozen.  Analyses 
comparing randomization arms will not be conducted until after the database is frozen. 
13.3. Objectives 
13.3.1. 
Objective #1: Atrial arrhythmias prior to re-ablation 
Summarize the documented atrial arrhythmias prior to re-ablation 
Endpoint Definition 
Each documented atrial arrhythmia will be classified into one of the following categories: 
• 
Atrial Fibrillation 
o Paroxysmal 
o Persistent 

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• 
Atrial Tachycardia 
• 
Atrial Flutter 
o Typical 
o Atypical 
• 
Other 
Analysis methods 
The first re-ablation for each subject will be used for analysis.  Each first re-ablation will be grouped into 
the following categories:  
1. atrial fibrillation (paroxysmal) 
2. atrial fibrillation (persistent) 
3. atrial flutter or atrial tachycardia 
4. other 
The percent of subjects by indication for re-ablation will be summarized.  The distribution of type of 
arrhythmia will be compared between randomization arms using exact methods. 
13.3.2. 
Objective #2: Reconnected pulmonary veins 
Summarize the number of reconnected pulmonary veins 
Endpoint Definition 
Each pulmonary vein will be classified as electrically isolated or not prior to re-ablation.  Electrically 
isolated is defined as bi-directional block, entrance and exit block of PV potentials. 
Analysis Methods 
The first re-ablation for each subject will be used for analysis. The number of electrically isolated 
pulmonary veins will be assessed for each subject and the number of PVs isolated will be compared 
between randomization arms using a two-sample t-test.  It is anticipated that the majority of subjects 
will have four major pulmonary veins; LIPV, LSPV, RIPV, and RSPV.  If a subject has an anatomy in which 
electrical isolation of more or less than the four major PVs are tested, the number of electrically isolated 
pulmonary veins for that subject will be normalized to 4.   
13.3.3. 
Objective #3: Number and location of gaps in pulmonary vein 
ablation lesions 
Summarize the number and location of gaps in pulmonary vein ablation lesions 
Endpoint: For a redo conducted with a focal catheter and 3D EA mapping, a gap within the pulmonary 
vein ablation lesion is defined as an electrically reconnected pulmonary vein which after a single spot re-
ablation the response to re-ablation is either PV re-isolation or PV activation-sequence change. Ongoing 
PV conduction after a single spot re-ablation is attributed to an additional gap. Additional gaps are 
defined similarly. 
For a redo conducted with no 3D EA Mapping, gap location may have been estimated utilizing a mapping 
catheter. 

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Each gap location will be identified by the classifications provided in Figure 2. To define the location of a 
gap, including the differentiation for spot gap or linear gap, the ipsilateral LA-PV junction is divided into 
6 equally distributed segments; superior, antero-superior, antero-inferior, inferior, postero-inferior, and 
postero-superior. 
Spot gap is defined as millimeter size, requiring only a single application without moving the catheter. 
Linear gap (larger continuous gap) is defined by requiring multiple applications or drawing of the 
catheter. 
Figure 2: Pulmonary Vein Gap Locations 
Analysis methods 
The number and location of gaps will be presented using summary statistics.  
13.3.4. 
Objective #4: Ablation lesion sets performed 
Summarize ablation lesion sets created during re-ablation procedure. 
Endpoint Definition 
Each lesion set during re-ablation will be classified into one of the following categories: 
• 
Pulmonary vein isolation (PVI) 
• 
LA AF Trigger 
• 
RA AF Trigger 
• 
Superior vena cava trigger 
• 
Inferior vena cava trigger 

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• 
Cavotricuspid Isthmus (CTI) 
• 
Mitral valve isthmus or line 
• 
Left sided roofline 
• 
Complex fractionated atrial electrogram (CFAE) 
• 
Posterior wall 
• 
AVNRT ablation 
• 
Other  
Analysis methods 
The first re-ablation for each subject will be used for analysis. The number of lesion sets for each subject 
will be counted.  If a subject has multiple PVs ablated, each PV will count as a lesion set towards the 
subjects total count.  The number of lesion sets will be compared between randomization arms using a 
two-sample t-test. 
13.3.5. 
Objective #5: Acute procedural success  
Summarize acute procedural success as assessed by the sites. 
Endpoint Definition:  
Definition of success for each lesion set found below 
• 
Pulmonary vein isolation (PVI) 
o Acute failure is defined as inability to isolate the pulmonary vein (minimally assessed for 
entrance block and, where assessable, exit block). Acute success is defined as the 
absence of acute failure. 
• 
LA AF Trigger 
o Acute success is defined as elimination of trigger by ablation procedure. 
• 
RA AF Trigger 
o Acute success is defined as elimination of trigger by ablation procedure. 
• 
Superior vena cava trigger 
o Acute success is defined as elimination of trigger by ablation procedure. 
• 
Inferior vena cava trigger 
o Acute success is defined as elimination of trigger by ablation procedure. 
• 
Cavotricuspid Isthmus (CTI) 
o Acute success is defined as bidirectional conduction block at the CTI line 
• 
Mitral valve isthmus ablation 
o Acute success is defined as bidirectional conduction block at the mitral isthmus line 
• 
Left atrial roofline 
o Acute success is defined as confirmed block at the roof line  

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• 
Left atrial posterior wall 
o Acute success is defined as confirmed block at the posterior wall 
• 
Complex fractionated atrial electrogram (CFAE) 
o Acute success is defined when ablation of electrograms resulted in termination of atrial 
fibrillation to sinus rhythm or until all complex fractionated regions were completely 
eliminated 
• 
AVNRT ablation 
o Acute success is defined as 1) no AVNRT inducibility; 2) no jump; 3) single echo only. 
• 
Other 
Analysis methods 
The first re-ablation for each subject will be used for analysis. For subjects receiving only re-isolation of 
pulmonary veins, acute procedural success is defined as minimally assessed for entrance block, and 
where assessable, exit block.  For subjects receiving additional lesions beyond PVI, acute success is 
defined as successful PVI plus successful ablations as defined in the endpoint definition for all ablations. 
Each subject will be classified as an acute procedural success or not.  Acute procedural success will be 
compared between randomization arms using exact methods. 
13.3.6. 
Objective #6: Re-ablation procedure times 
Summarize re-ablation procedure times. 
Endpoint: 
1. Total procedure time is defined as time from first venous access to time of last sheath removal. 
2. Left atrial dwell time is defined as time from transseptal puncture to time of removal of last 
sheath from the left atrium. 
3. Fluoroscopy time is defined as total fluoroscopy time used during the procedure. 
Ablation methods 
The first re-ablation for each subject will be used for analysis. Procedural times will be compared 
between randomization arms with a two-sample t-test.  Separate t-tests will be used for each procedure 
time metric. 
13.3.7. 
Objective #7: Hospitalization length of stay 
Summarize the length of stay during the hospitalization for re-ablation 
Endpoint Definition 
Length of stay is defined as the number of days from admission to discharge. 
Analysis Methods 
The first re-ablation for each subject will be used for analysis. Hospital length of stay will be compared 
between randomization arms with a two-sample t-test. If the distribution of length of stay is skewed 
non-normal, a non-parametric Wilcoxon test will be utilized. 

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13.3.8. 
Objective #8: Anti-arrhythmic drug use at discharge 
Summarize the anti-arrhythmic drug use at time of discharge from the re-ablation procedure. 
Endpoint Definition 
Anti-arrhythmic drug is defined as a Class I or III antiarrhythmic drug prescribed at discharge. 
Analysis Methods 
The first re-ablation for each subject will be used for analysis. The percent of subjects discharged from 
re-ablation on anti-arrhythmic drugs will be compared between randomization arms using exact 
methods. 
13.3.9. 
Objective #9: Adenosine testing 
Summarize adenosine testing utilized during re-ablation procedure. 
Endpoint Definition 
Use of adenosine testing during re-ablation. 
Analysis Methods 
The first re-ablation for each subject will be used for analysis. The percent of subjects with adenosine 
testing will be compared between randomization arms using binomial exact methods. 
14. Ethics 
14.1. Statement(s) of Compliance 
This retrospective data collection will be conducted in accordance with the clinical investigation plan, 
the International Conference on Harmonization Guidelines (ICH) on Good Clinical Practice (GCP) the 
Data Protection Directive (95/46/EC) as well as all applicable country-specific data protection 
regulations and the ethical principles that have their origin in the Declaration of Helsinki (18th World 
Medical Assembly, Helsinki 1964) and all applicable amendments laid down by the World Medical 
Assemblies. The principles of the Declaration of Helsinki have been implemented through adherence to 
accepting scientific principles, the subject Data Release Form process, EC / IRB approval, project training, 
clinical trial registration, risk-benefit assessment and publication policy. No vulnerable subject groups 
were included in the FIRE AND ICE Trial. 
Due to the set-up of this project, being a retrospective data collection (focused on re-ablation data) in 
addition to the data already collected within the FIRE AND ICE Trial, full compliance to ICH GCP is not 
given due to not applicable elements for this type of project. 
Before initiating any sites in any country for the retrospective data collection, approval/notification of 
the relevant EC / IRB and/or competent authority will be obtained as appropriate per local regulations. 

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In case any action is taken by an EC / IRB with respect to this retrospective data collection, the sponsor 
should be informed immediately about the action taken (via the investigator or the assigned CRA). 
15. Study Administration 
15.1. Monitoring 
Authorized, qualified clinical research associates (CRAs) of the CRO (genae associates nv with global 
headquarters at Justitiestraat 6B, 2018 Antwerp, Belgium) will accomplish the monitoring of the 
collected retrospective data per the project specific monitoring plan. Remote monitoring is also 
accepted for this CIP. No sponsor monitors will be involved for this retrospective data collection. 
Assignment of the genae CRAs per participating site is documented in the project specific monitoring 
plan. 
All sites to be initiated for this retrospective data collection were active enrolling hospitals within the 
FIRE AND ICE Trial and therefore already experienced regarding the content of this additional data 
collection. Site Initiation Visits (SIVs) under this CIP may be conducted via phone. The SIV (via on-site 
visit or phone) can take place when the clinical trial agreement is fully executed, confidentiality 
agreement is fully executed, ethics approval is obtained (as applicable), competent authority 
requirements are fulfilled (as applicable), signed and dated CV of the principal investigator is available, 
approved data release form and sponsor approval/request to conduct the SIV. 
COVs will be conducted either via a visit (may be a combined visit with the last monitoring visit) or by 
phone as soon as the additional data collection is completed. There will be no data collection after that 
time. 
It is important that the investigator and relevant site personnel are available during the monitoring visits 
and that appropriate location, internet access and enough time is devoted to the process. Access to all 
applicable source documents as defined in Section 10.9 Recording Data needs to be ensured for the 
CRA. A personal computer with internet access should be available to the CRA for all data stored in the 
data system of the hospital or catheter lab as applicable. 
The main duty of the contracted genae CRA is to help Medtronic and investigator to maintain a high 
level of data and regulatory quality in all aspects of the retrospective data collection. For this purpose, 
the CRA will verify on site all signed data release forms (100%) as well as conducting verification on data 
entered into the eCRF as defined in the monitoring plan (SDV – Source Data Verification). Within the 
project specific monitoring plan the extent of SDV is defined, such as 100% SDV on key data for the 
defined objectives, 10% SDV for e.g. medication data and data items to be only checked for 
completeness. 

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15.2. Data Management 
The data management and statistical analysis plan defines the procedures for data review, database 
cleaning and issuing and resolving data queries as well as the procedures for verification, validation and 
securing of electronic clinical data systems if applicable. 
Data will be collected using an electronic data management system for clinical studies. eCRF data will be 
stored in a secure, password-protected database. Data will be reviewed using programmed and manual 
data checks. Data queries will be made available to participating sites for resolution. Project 
management reports may be generated to assess data quality and data entry progress. At the end of the 
project, the data will be frozen and will be retained indefinitely by Medtronic. All records and other 
information about subjects participating in the project will be treated as confidential. 
15.3. Direct Access to Source Data/Documents  
The investigator agrees that representatives or the designee of Medtronic such as CRAs and auditors, 
and appropriate Regulatory Agencies will be given direct access to the regular clinical files of the subject. 
Direct access is defined as the permission to examine, analyze, verify and reproduce any records and 
reports that are important for this retrospective data collection. Any party with direct access should take 
all reasonable precautions within this constraint of the applicable regulatory requirements to maintain 
the confidentiality of subject identities and Medtronic proprietary information. 
Quality assurance is defined as the planned and systematic actions that are established to ensure that 
the retrospective data collection is performed and the documented data collected in compliance with 
GCP and the applicable regulatory requirements. 
 
 

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The investigator should permit in addition to the regular monitoring and EC/IRB reviews, also auditing by 
or on behalf of Medtronic and inspection by applicable regulatory authorities. The investigator shall take 
appropriate measures required by Medtronic to take corrective actions for all problems found during 
the audit or inspections. 
15.4. Confidentiality 
General 
All information disclosed or provided by Medtronic (or any company / institution acting on his behalf), 
or collected during the retrospective data collection, including, but not limited to, the clinical 
investigation plan, the eCRFs and the results/data obtained, is confidential. The investigator or any 
person under his / her authority agrees to undertake to keep confidential and not do disclose the 
information to any third party without the prior written approval of Medtronic. Co-Investigators as 
applicable shall be bound by the same obligations as the investigator. The investigator shall inform the 
co-investigators of the confidential nature of this project as applicable. Both, the investigator and the 
co-investigators shall use the information solely for the purpose of the project, to the exclusion of any 
use for their own or for a third party’s account. 
Subject privacy 
All subject data collected under this CIP will be handled strictly confidential and pseudonymized, no 
names or initials will be used, but only a numeric code and possibly the data of the year of birth. The 
same subject identifiers will be used as for the FIRE AND ICE Trial to ensure the correct merge of both 
data sets for the analyses. All analyses performed will be made on pseudonymized data only. Also all 
results published based on this retrospective data collection will be without disclosing confidential 
subject data. 
All subject data will be protected against unauthorized access and a decryption takes place only under 
the conditions by the country-specific law. 
15.5. Liability (N/A) 
Retrospective data collection only without direct subject involvement. 
 
 

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15.6. CIP Amendments 
Approval of amendments to the CIP are required are required at each participating site from the 
following groups prior to implementation of the revised CIP at the participating site:  
• 
Medtronic 
• 
Principal Investigator (where required by local law) 
• 
Competent / Regulatory Authority (if regulatory approval is required) 
• 
Central IRB / EC 
If a CIP amendment occurs, site personnel will need to be re-trained as necessary, and will need to 
submit any changes to their IRB / ECs as required by the local committee. 
In some instances, an amendment may require a change in the data release form. In this case, the 
investigator must receive an EC / IRB approval / favorable opinion concerning the revised data release 
form prior to implementation of the change. 
15.7. Record Retention 
The investigator must maintain confidential all project documentation, and take measures to prevent 
accidental or premature destruction of these documents. The investigator must retain the related 
documents at least five year after the completion or discontinuation of this retrospective data collection 
or longer if required by national legislation. This includes, but is not limited to the following documents:  
• 
Signed CIP and amendments (as applicable) 
• 
Issued regulatory approvals (communication with regulatory authorities / ECs) 
• 
Clinical Trial Agreement 
• 
Signed Data Release Forms 
• 
Subject Identification Listings 
• 
Site team authorizations including training documentation and qualification documentation 
• 
CRF pages 
• 
Lab- and medical files 
• 
Site Close Out Report 
• 
Relevant project communication, including as applicable audit and inspection documentation 
• 
Project reports / final project report 
The investigator must notify Medtronic prior to destroying any essential project documents within the 
specified period following completion or discontinuation of the project. 
Medtronic records and reports will be maintained in a password-protected document management 
system, and paper documents (where applicable) will be stored in secured file cabinets at genae (CRO) 
during the course the project. Document transfer from genae to Medtronic is part of the defined CRO 
project closing activities. 
After closure of the project Medtronic will archive records and reports indefinitely. 

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15.8. Publication and Use of Information 
Publications from the FIRE AND ICE Re-Ablations retrospective data collection will be handled according 
to Medtronic Global Standard Operating Procedures and as indicated in the Clinical Trial Agreement 
(CTA).  
The publication rules are regulated separately and described in detail in a publication plan that is 
confirmed by the publication committee. The overall process and content of the publication plan is 
comparable with the FIRE AND ICE Trial. Registering and posting the project results on ClinicalTrials.gov 
will be done based on the posting rules stipulated. 
Medtronic will be responsible for preparing any reports based on the additional retrospective data 
collection. A final report, describing the results of all objectives and analysis, will be distributed to all 
investigators, IRBs/ECs and CAs of participating countries when required by local law. 
An individual site’s study data will be made accessible to the corresponding investigator after the 
completion of the project, if requested. 
All information and documents provided by Medtronic or its representatives are and remain the sole 
property of Medtronic. The investigator shall not mention any information for any other intellectual 
property rights. 
All results, data and documents, which arise directly or indirectly from this project in any form, shall be 
the immediate and exclusive property of Medtronic. 
Publication Committee 
Medtronic will form the FIRE AND ICE Re-Ablations Publication Committee (refer to Appendix V). 
Medtronic personnel may serve as members of the committee. This committee will manage publications 
with the goal of publishing findings from the data. The publication committee will develop the 
publication plan as a separate document. 
The publication committee’s role is to 1) manage and develop elements addressed in the publication 
plan, 2) execute the publication plan, 3) oversee the publication of primary, secondary and ancillary 
study results as applicable, 4) review and prioritize publication proposals, 5) provide input on publication 
content, and 6) determine authorship. In addition, the committee will apply and reinforce the 
authorship guidelines set forth in the publication plan.  
Membership in the publication committee does not guarantee authorship. The committee will meet as 
needed. 

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15.9. Suspension or Early Termination 
Early termination is the closure of a clinical study/project that occurs prior to meeting defined endpoints 
or objectives. This is possible for the whole study/project or a single participating site. Suspension is a 
temporary postponement of study/project activities related to enrollment. This is possible for the whole 
study/project or a single participating site. If suspension is lifted, the investigator shall assess whether or 
not to continue the clinical study/project at their site.  
Possible reasons for considering suspension or termination of this retrospective data collection include 
but are not limited to:  
• 
Decision by Medtronic or competent authority 
Possible reasons for investigator or participating site termination or suspension include but are not 
limited to:  
• 
Persistent non-compliance to the CIP (e.g. lack of data entry) 
• 
Noncompliance to regulations and the terms of the CTA (e.g. failure to submit data in a timely 
manner, failure to follow-up on data queries and monitoring findings in a timely manner, etc.) 
• 
IRB/EC suspension of the participating site 
• 
Fraud or fraudulent misconduct is discovered (as defined by local law and regulations) 
• 
Investigator request (e.g. no longer able to support the retrospective data collection) 
Procedures Medtronic-initiated / Regulatory-initiated termination or suspension 
• 
Medtronic will promptly inform the investigators of the termination or suspension and the 
reasons and inform the regulatory authority(ies) where required 
• 
The investigator will promptly inform the IRB/EC of project termination or suspension 
• 
In the case of project termination, the investigator must inform the subjects; information of the 
personal physician of the subjects to ensure appropriate care and follow-up is not required, as 
this is a retrospective data collection only 
• 
In the case of a study suspension, entry of new subject data must stop until the suspension is 
lifted by Medtronic 
• 
No new assessments or follow-up are part of this retrospective data collection; therefore, no 
direct impact on the patient care and welfare 
 
 

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Procedures Investigator-initiated termination or suspension 
• 
The investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension. 
• 
The investigator will promptly inform the institution (where required per regulatory 
requirements) 
• 
The investigator will promptly inform the IRB/EC 
• 
The investigator will promptly inform the regulatory authorities (where required per regulatory 
requirements) 
• 
The investigator will promptly inform the subjects 
• 
No new assessments or follow-up are part of this retrospective data collection; therefore, no 
direct impact on the patient care and welfare 
Procedures IRB/EC-initiated termination or suspension 
• 
The investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension within 5 business days 
• 
Entry of new data sets in the database must stop until the suspension is lifted 
• 
The investigator will inform his/her institution (where required per local requirements) 
• 
The investigator will promptly inform the subjects with the rationale for the project termination 
or suspension 
• 
The investigator will promptly inform the regulatory authorities (where required per regulatory 
requirements) 
• 
No new assessments or follow-up are part of this retrospective data collection; therefore, no 
direct impact on the patient care and welfare 
 
 

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16. References 
1. Fürnkranz A, Brugada J, Albenque JP, Tondo C, Bestehorn K, Wegscheider K, Ouyang F, Kuck 
KH. Rationale and Design of FIRE AND ICE: a multicenter randomized trial comparing 
efficacy and safety of pulmonary vein isolation using a cryoballoon versus radiofrequency 
ablation with 3D-reconstruction. J Cardiovasc Electrophysiol 2014;25:1314-1320 
2. Karl-Heinz Kuck, M.D., Joseph Brugada, M.D., Alexander Fürnkranz, M.D., Andreas Metzner, 
M.D., Feifan Ouyang, M.D., K.R. Julian Chun, M.D., Arif Elvan, M.D., Ph.D, Thomas Arentz, 
M.D., Kurt Bestehorn, M.D., Stuart J. Pocock, Ph.D., Jean-Paul Albenque, M.D., Ph.D., and 
Claudio Tondo, M.D., Ph.D., for the FIRE AND ICE Investigators: Cryoballoon or 
Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med 2016;374:2235-
2245 
3. Karl-Heinz Kuck, Alexander Fürnkranz, K.R. Julian Chung, Andreas Metzner, Feifan Ouyang, 
Michael Schlüter, Arif Elvan, Hae W. Lim, Fred J. Kueffer, Thomas Arentz, Jean-Paul 
Albenque, Claudio Tondo, Michael Kühne, Christian Sticherling, and Joseph Brugada, on 
behalf of the FIRE AND ICE Investigators: Cryoballoon or radiofrequency ablation for 
symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-
life 
outcomes 
in 
the 
FIRE 
AND 
ICE 
trial. 
European 
Heart 
Journal 
doi:10.1093/eurheartj/ehw285. 
4. Calkins H, et al. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and 
Surgical Ablation of Atrial Fibrillation: recommendations for patient selection, procedural 
techniques, patient management and follow-up, definitions, endpoints, and research trial 
design. Heart Rhythm. 2012; 9(4): p. 632-696 
5. 
Appendices  
Appendix I – List of Participating Countries 
Appendix II – List of Participating Sites and Investigators 
Appendix III – Data Release Form (DRF) 
Appendix IV – Members of Endpoint Review Committee (ERC) 
Appendix V – Members of Publication Committee 
6. 
Version History 
Version 
Summary of Changes 
Author(s)/Title 
1.0 
• 
Not Applicable, New Document 
Petra Kremer, Pr. Clinical Research 
Specialist 
Fred Kueffer, Sr. Pr. Statistician 
 
 

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Appendix I – List of Participating Countries 
(sorted in alphabetical order) 
Country 
Czech Republic 
France 
Germany 
Hungary 
Netherlands 
Spain 
Switzerland 
 
 

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Appendix II – List of Participating Clinical Sites and Investigators 
(sorted in alphabetical order by participating country) 
Any changes to this committee will be provided under separate cover as needed. 
Country 
Site 
Principal Investigator 
Czech Republic 
Nemocnice Na Homolce Praha 
Roentgenova 2, 150 30 Praha 5 
Prof. Dr. Petr Neuzil 
Head of Department of 
Cardiology 
France 
Clinique Pasteur Toulouse 
43, avenue de Lombez BP 27617, F-31076 
Toulouse Cedex 3 
Dr. Jean-Paul Albenque 
Cardiologist / Department de 
Rythmologie 
Germany 
Asklepios Klinik St. Georg Hamburg 
Lohmühlenstr. 5, 20099 Hamburg 
Prof. Dr. Karl-Heinz Kuck 
Head of Department of 
Cardiology 
Cardioangiologisches Centrum Bethanien CCB, 
Frankfurt 
Wilhelm-Epstein-Str. 4, 60431 Frankfurt 
PD Dr. KR Julian Chun 
Doctor of Cardiology 
Universitätsmedizin Greifswald 
Ferdinand-Sauerbruch-Straße, 17475 Greifswald 
Dr. Mathias C. Busch 
Oberarzt Kardiologie / senior 
physician 
Herz-Zentrum Bad Krozingen 
Südring 15, 79189 Bad Krozingen 
Prof. Dr. Thomas Arentz 
Chefarzt Rhythmologie / chief 
physician 
Klinikum Bad Neustadt 
Salzburger Leite 1, 97616 Bad Neustadt 
Prof. Dr. Thomas Deneke 
Leiter der Klinik für Kardiologie 
II / Head of Cardiology 
Herz-Zentrum Bodensee 
Luisenstraße 9a, 78464 Konstanz 
Prof. Dr. Volker Kühlkamp 
Chefarzt Elektrophysiologie / 
Head of electrophysiology 
Hungary 
Semmelweis Egyetem Budapest 
Dr. László Alajos Gellér 

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Üllöi út 26, H-1085 Budapest 
Cardiologist 
Netherlands 
Isala Klinieken Zwolle 
Dokter van Heesweg 2, 8025 AB Zwolle 
Dr. Arif Elvan 
Cardiologist 
Spain 
Hospital Clinic de Barcelona 
Carrer de Villarroel, 170, Escala 3, Planta 6, 08036 
Barcelona 
Dr. Josep Lluís Mont Girbau 
Cardiologist / Head of 
Arrhythmia Section 
Hospital Clínico Universitario "Virgen de la 
Victoria" Malaga 
Campus Universitario de Teatinus s/n, 29010 
Málaga 
Dr. Alberto Barrera Cordero 
Cardiologist 
Hospital Clinico Universitario Valencia 
Avenida Blasco IBA#EZ 17, 46010 Valencia 
Dr. Ricardo Ruiz-Granell 
Cardiologist / 
Electrophysiologist 
Hospital Clinico San Carlos Madrid 
Professor Martín Lagos, S/N, 28040 Madrid 
Dr. Nicasio Pérez Castellano 
Cardiologist 
Switzerland 
Universitätsspital Basel 
Petersgraben 4, CH-4031 Basel 
PD Dr. Michael Kühne 
Leiter Vorhofflimmerklinik 
/Head of AF department 
 
 

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Appendix III – Data Release Form (Master Version) 
INFORMATION SHEET 
Investigator and Sponsor 
 
Study 
FIRE AND ICE RE-Ablations 
Sponsor 
Medtronic International Trading Sàrl 
Route du Molliau 31 
1131 Tolochenaz 
Switzerland 
Site 
<Insert site name> 
Investigator 
<Insert name and title of the site Principal Investigator (PI)> 
 
 
This study is a multi-center Non-Interventional Post-Market study to collect retrospective data on re-
ablation procedures performed during the Follow-Up period of the FIRE AND ICE study.  
PURPOSE OF THE STUDY: 
The purpose of this study is to collect procedural data of performed re-ablation procedures in patients 
with re-current atrial fibrillation after a performed ablation procedure, treated either with a cryoballoon 
ablation or a radiofrequency ablation. These data are collected for medical research purposes to gather 
information on products (ablation catheters) and their performance during and after the current study. 
You (and about 115 other patients) are invited to take part in this study, because you were a participant 
in the Fire and Ice study and were diagnosed with recurrent atrial fibrillation after the performed study 
ablation procedure and you have been treated with a re-ablation procedure by your doctor. The data of 
this re-ablation procedure was not collected during the initial Fire and Ice study, but is now of interest 
for this study. 
USE OF PERSONAL DATA/CONFIDENTIALITY: 
Your participation in this study is entirely voluntary and confidential. 
While participating in this study the following personal data will be collected:  
• 
identifying data (name, age, address) < 
• 
medical and health data from your medical records incl. data about your treatment, especially the 
atrial fibrillation procedure and your medication 
 
   (hereinafter “personal data”) 

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Your personal data will be processed at all times in accordance with applicable legal requirements.  
In general only the study doctor and/or nurse as well as the study monitor who acts on behalf of 
Medtronic and other designated parties that are involved in the study have direct access to your 
personal data in your medical file. Furthermore it may happen, that members of the ethical committee 
and representatives of national, European or other international public authorities are granted direct 
access to your personal data in order to comply with legal requirements. 
For conducting the study your personal data will be transferred to and processed by Medtronic 
(meaning Medtronic, Inc. as well as all affiliates of this group of companies) or a third party designated 
by Medtronic – but solely in a key coded form. Key coded form means that your name, date of birth, 
contact information, and any other information that might disclose your identity, will be replaced by a 
Patient Identification number (Patient ID). Only this Patient ID will be used on the study documents and 
reports. The key between this Patient ID and your identity will be kept on site by the study staff team. 
Your key coded personal data will be transferred to Medtronic or a third party designated by Medtronic 
which is located in the country where you are treated or in a other member state of the European 
Economic Area but maybe also in the United States or another country where the European Directive on 
Data Protection does not apply. 
Medtronic may also use your coded personal data for additional purposes such as overseeing and 
improving the performance of its device, new medical research, developing new medical products or 
procedures, and other business purposes.  
You are entitled to access the personal data collected about you and to have inaccuracies corrected. 
Any published information including reports and articles about the study will not include your name or 
any information that could personally identify you.  Information received during the study will not be 
used to market to you; your name will not be placed on any mailing lists or sold to anyone for marketing 
purposes.  
If you agree upon, your personal physician will be informed about your participation in the study. 
 
 

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SIGNATURE SHEET 
(ISO 14155: 2011 4.7.5) 
 
I have read the patient information of this study and my study doctor has answered all my questions 
regarding the study.  
I had sufficient time to consider my participation into this study, I am aware that participation into this 
study is completely voluntary, and I agree to follow the instructions from the study doctor.  
I realize that I may decide to refuse participation or stop participation at any time without penalty and 
without affecting the quality of my health care or the relationship with my study doctor.  
I understand and agree that personal information about me will be collected from my medical records, 
used and processed (manually and by computer) by the manufacturer of a medical device used in my 
treatment or any other designated party that is involved in the study (e.g. hospital, study doctor, 
regulatory authorities, ethics committees). 
I understand and agree that representatives from Medtronic, regulatory authorities and the Ethics 
Committee representatives will be granted direct access to my medical records. 
I understand and agree that the study doctor(s)/hospital will release the relevant personal information 
about me for the purpose of this study.  
I understand that I am entitled to access the personal information collected about me and to have 
inaccuracies corrected. 
I agree to participate voluntarily in and comply with this study. 
I understand that I will receive a dated and signed copy of the Data Release Form. 
• 
This notification can be deleted for countries where personal physicians do not exist 
• 
Use if EC requires a checkbox 
 
It is your choice if you would like your personal physician to be informed of your participation in this 
study. Please, check one of the boxes to show your choice: 
 
! must be checked by patient 
 
I agree that my personal physician is informed about my participation in this study. 
 
I disagree that my personal physician is informed about my participation in this study. 
 
 
 

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Patient: 
 
 
 
 
 
 
 
 
 
Name 
 
Signature 
 
Date (dd MMM yyyy) 
 
 
! must be written by 
patient 
 
! must be written by 
patient 
 
 
 
 
 
 
 
 
 
 
 
Legal Representative if patient is unable to give consent: 
 
 
 
 
 
 
 
 
Name 
 
Signature 
 
Date (dd MMM yyyy) 
 
 
! must be written by  
Legal Representative 
 
! must be written by  
Legal Representative 
 
 
 
 
 
 
 
 
Study doctor or designated person by study doctor:   
 
I have conducted the informed consent discussion. 
 
 
 
 
 
 
 
 
Name 
 
Signature 
 
Date (dd MMM yyyy) 
 
 
 
 Only persons officially trained and 
authorized on the delegated task 
list are allowed to sign off  

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If patient, or patient’s legally acceptable representative, is unable to read: 
 
I have attended the entire Data Release discussion. I attest that the information in the consent form and 
any other written information was accurately explained to, and apparently understood by, the patient 
or the patient’s legally acceptable representative. Data Release consent was freely given by the patient 
or the patient’s legally acceptable representative. 
 
 
Impartial Witness: 
 
 
 
 
 
 
 
 
Name 
 
Signature 
 
Date (dd MMM yyyy) 
 
 
! must be written by  
Impartial Witness 
 
! must be written by  
Impartial Witness 
 
 
 
 
 
 
 
 
 

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Appendix IV – Members of Endpoint Review Committee (ERC) 
(sorted in alphabetical order) 
Any changes to this committee will be provided under separate cover as needed. 
Member Name 
Institution  
Dr. Malte Kuniss 
Kerckhoff Klinik Bad Nauheim 
Benekestr. 2-8 
D-61231 Bad Nauheim 
Prof. Dr. Thorsten Lewalter 
Peter Osypka Herzzentrum 
Am Isar-Kanal 36 
D-81379 München, Germany 
Prof. Dr. Lars Lickfett 
Gemeinschaftspraxis für Kardiologie und Pneumologie 
Mönchengladbach 
Ludwig Weber Straße 15 
D-41061 Mönchengladbach 
 
 

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Appendix V – Members of Publication Committee 
(voting members are sorted in alphabetical order) 
Any changes to this committee will be provided under separate cover as needed. 
Member Name 
Institution  
Dr. Jean-Paul Albenque 
Clinique Pasteur 
45 avenue de Lombez 
BP 27617 
31076 Toulouse Cedex 3, France 
Prof. Dr. Josep Brugada 
(Co-Chairman) 
Hospital Clinic, University of Barcelona 
Villarroel 170,  
08036 Barcelona, Spain 
Prof. Dr. Karl-Heinz Kuck 
(Chairman) 
Asklepios Klinik St. Georg 
Lohmühlenstr. 5 
D-20099 Hamburg, Germany 
Prof. Dr. Claudio Tondo 
Cardiac Arrhythmia Research Centre 
Department of Cardiovascular Medicine  
Centro Cardiologico Monzino 
University of Milan 
Via Parea 4 
20138 Milan, Italy 
Fred Kueffer 
(Medtronic member) 
Medtronic Inc. 
8200 Coral Sea St., N.E. 
Mounds View, MN 55112, USA 
Dr. Hae Lim 
(Medtronic member) 
Medtronic Inc. 
8200 Coral Sea St., N.E. 
Mounds View, MN 55112, USA 
Dr. Ralf Meyer 
(Medtronic member) 
Medtronic International Trading Sárl 
Route du Molliau 31, Case postale 84 
CH-1131 Tolochenaz – Switzerland 
Petra Kremer 
(Medtronic member) 
Medtronic International Trading Sárl 
Route du Molliau 31, Case postale 84 
CH-1131 Tolochenaz – Switzerland