FIRE AND ICE: Comparative Study of Two Ablation Procedure... | NCT01490814

Name	Class
Medtronic	INDUSTRY

Label	Type	Description	Intervention Names
Cryoballoon ablation	Active Comparator		Procedure: Electrical isolation of the pulmonary veins
Radiofrequency ablation	Active Comparator		Procedure: Electrical isolation of pulmonary veins

Name	Type	Description	Arm Group Labels	Other Names
Electrical isolation of the pulmonary veins	Procedure	Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.

Measure	Description	Time Frame
Number of Subjects With Recurrence of Atrial Arrhythmias or Prescription of Anti-arrhythmic Drug or Re-ablation After a Blanking Period of Three Months After the Initial Ablation Procedure	Number of subjects reporting a primary efficacy endpoint	33 months
Number of Subjects With a Primary Safety Event. A Primary Safety Event Includes a Composite of Death (Including Cardiovascular Death), All-cause Stroke/Transient Ischemic Attack (TIA) and Serious Adverse Events of Special Interest.		33 months

Measure	Description	Time Frame
All-cause Death		33 months
Arrhythmia-related Death		33 months
Total Procedure Duration

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptomatic PAF with at least two episodes and at least one episode documented (30 seconds episode length, documented by ECG within last 12 months).
Documented treatment failure for effectiveness of at least one anti-arrhythmic drug(AAD Type I or III, including β-blocker and AAD intolerance).
≥ 18 and ≤ 75 years of age.
Patients who are mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol.
Patient is able to verbally acknowledge and understand the associated risks, benefits, and treatment alternatives to therapeutic options of this trial: cryoballoon ablation system or standard RF ablation technique. The patients, by providing informed consent, agree to these risks and benefits as stated in the patient informed consent document. All the details have been presented to him and he has signed the informed consent form for the trial.

Exclusion Criteria:

General exclusion criteria

Any disease that limits life expectancy to less than one year.
Participation in another clinical trial (of a drug, device or biologic), either within the past two months or ongoing.
Pregnant women or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception [oral contraception or intrauterine device (IUD)] or sterile women can be randomized.
Breastfeeding women.
Substance misuse.
Active systemic infection.
Cryoglobulinaemia.
Previous participation in this clinical trial.
Employment by the sponsor or by the department of any of the investigators.
Close relatives of any of the investigators.

Exclusion criteria related to a cardiac condition

Patients with prosthetic valves.
Any previous LA ablation or surgery.
Any cardiac surgery or percutaneous coronary intervention (PCI) within three months prior to enrollment.
Unstable angina pectoris.
Myocardial infarction within three months prior to enrollment.
Symptomatic carotid stenosis.
Chronic obstructive pulmonary disease with detected pulmonary hypertension.
Any condition contraindicating chronic anticoagulation.
Stroke or transient ischemic attack within six months prior to enrollment.
Any significant congenital heart defect corrected or not (including atrial septal defects or PV abnormalities) but not including patent foramen ovale.
New York Heart Association (NYHA) class III or IV congestive heart failure.
EF < 35 % (determined by echocardiography within 60 days of enrollment as documented in patient medical history).
Anteroposterior LA diameter > 55 mm (by trans-thoracic echocardiography (TTE or TEE) within three months to prior enrollment).
LA thrombus (TEE diagnostic performed on admission).
Intracardiac thrombus.
PV diameter > 26 mm in right sided PVs.
Mitral prosthesis.
Hypertrophic cardiomyopathy (see Appendix IX)
2° (Type II) or 3° atrioventricular block.
Brugada syndrome or long QT syndrome.
Arrhythmogenic right ventricular dysplasia.
Sarcoidosis.
PV stent.
Myxoma.

Exclusion criteria based on laboratory abnormalities

Thrombocytosis (platelet count > 600,000 / µl), thrombocytopenia (platelet count < 100,000 / µl).
Any untreated or uncontrolled hyperthyroidism or hypothyroidism.
Severe renal dysfunction (stage V, requiring or almost requiring dialysis, glomerular filtration rate (GFR) < 15 ml / min).

Name	Affiliation	Role
Karl-Heinz Kuck, Prof. Dr.	Asklepios Klinikum St. Georg	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Na Homolce Hospital, Cardiology		Prague		515030	Czechia
Hospital Henri Mondor CHU, Service de Cardiologie

PubMed Identifier	Type	Citation	Retractions
25146732	Background	Furnkranz 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 Dec;25(12):1314-20. doi: 10.1111/jce.12529. Epub 2014 Nov 12.
27042964

Label	URL
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.	View source

ID	Title	Description
FG000	Cryoballoon Ablation	Electrical isolation of the pulmonary veins: Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.

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 Subjects With Recurrence of Atrial Arrhythmias or Prescription of Anti-arrhythmic Drug or Re-ablation After a Blanking Period of Three Months After the Initial Ablation Procedure

Number of subjects reporting a primary efficacy endpoint

Subjects randomized and received an ablation procedure. Modified intent-to-treat (mITT) population.

Posted

Count of Participants

Participants

33 months

ID	Title	Description
OG000	Cryoballoon Ablation	Electrical isolation of the pulmonary veins: Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
OG001	Radiofrequency Ablation	Electrical isolation of pulmonary veins: Device:NaviStar® ThermoCool® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.

Units	Counts
Participants	OG000374 OG001376

Title

Denominators

Categories

Title	Measurements
	OG000138 OG001143

Primary

Number of Subjects With a Primary Safety Event. A Primary Safety Event Includes a Composite of Death (Including Cardiovascular Death), All-cause Stroke/Transient Ischemic Attack (TIA) and Serious Adverse Events of Special Interest.

Subjects randomized and received an ablation procedure. Modified intent-to-treat (mITT) population.

Posted

Count of Participants

Participants

33 months

ID	Title	Description
OG000	Cryoballoon Ablation	Electrical isolation of the pulmonary veins: Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
OG001	Radiofrequency Ablation	Electrical isolation of pulmonary veins: Device:NaviStar® ThermoCool® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.

Units	Counts

Secondary

All-cause Death

Subjects randomized and received ablation. Modified intent-to-treat (mITT) population.

Posted

Count of Participants

Participants

33 months

ID	Title	Description
OG000	Cryoballoon Ablation	Electrical isolation of the pulmonary veins: Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
OG001	Radiofrequency Ablation	Electrical isolation of pulmonary veins: Device:NaviStar® ThermoCool® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.

Units	Counts
Participants

Secondary

Arrhythmia-related Death

Subjects randomized and received an ablation procedure. Modified intent-to-treat (mITT) population.

Posted

Count of Participants

Participants

33 months

ID	Title	Description
OG000	Cryoballoon Ablation	Electrical isolation of the pulmonary veins: Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
OG001	Radiofrequency Ablation	Electrical isolation of pulmonary veins: Device:NaviStar® ThermoCool® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.

Units	Counts
Participants

Secondary

Total Procedure Duration

Subjects randomized and received ablation. Modified intent-to-treat (mITT) population.

Posted

Mean

Standard Deviation

minutes

Through the initial ablation procedure

ID	Title	Description
OG000	Cryoballoon Ablation	Electrical isolation of the pulmonary veins: Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
OG001	Radiofrequency Ablation	Electrical isolation of pulmonary veins: Device:NaviStar® ThermoCool® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.

Units	Counts
Participants

Secondary

Total Time of Fluoroscopy

Subjects randomized and received ablation procedure. Modified intent-to-treat (mITT) population

Posted

Mean

Standard Deviation

minutes

Fluoroscopy meter time through the initial ablation procedure

ID	Title	Description
OG000	Cryoballoon Ablation	Electrical isolation of the pulmonary veins: Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
OG001	Radiofrequency Ablation	Electrical isolation of pulmonary veins: Device:NaviStar® ThermoCool® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.

Units	Counts
Participants

Secondary

Number of Subjects Reporting a Cardiovascular Hospitalization Over the Duration of the Study.

Subjects randomized and received an ablation procedure. Modified intent-to-treat (mITT) population.

Posted

Count of Participants

Participants

33 months

ID	Title	Description
OG000	Cryoballoon Ablation	Electrical isolation of the pulmonary veins: Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
OG001	Radiofrequency Ablation	Electrical isolation of pulmonary veins: Device:NaviStar® ThermoCool® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.

Units	Counts
Participants

Secondary

Number of Cardiovascular Hospitalizations

The total number of cardiovascular hospitalizations reported over the duration of the study.

Subjects randomized and received an ablation procedure. Modified intent-to-treat (mITT) population.

Posted

Number

number of cardiovascular hospitalization

33 months

ID	Title	Description
OG000	Cryoballoon Ablation	Electrical isolation of the pulmonary veins: Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
OG001	Radiofrequency Ablation	Electrical isolation of pulmonary veins: Device:NaviStar® ThermoCool® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
ABDOMINAL PAIN UPPER	GASTROINTESTINAL DISORDERS	MedDRA 17.1	EG0002 events2 affected374 at risk EG0010 events0 affected376 at risk
ACCIDENT	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
ADVERSE DRUG REACTION	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
ANESTHETIC COMPLICATION PULMONARY	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
ANGINA PECTORIS	CARDIAC DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
ANGINA UNSTABLE	CARDIAC DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
ANXIETY	PSYCHIATRIC DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
AORTIC ANEURYSM	VASCULAR DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0011 events1 affected376 at risk
AORTIC DISSECTION	VASCULAR DISORDERS	MedDRA 17.1	EG0002 events1 affected374 at risk EG0010 events0 affected376 at risk
ARTERIOGRAM CORONARY	INVESTIGATIONS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
ARTERIOVENOUS FISTULA	VASCULAR DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0013 events3 affected376 at risk
ARTERITIS	VASCULAR DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
ARTHRALGIA	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
ASPIRATION	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
ASTHENIA	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	MedDRA 17.1	EG0002 events2 affected374 at risk EG0012 events2 affected376 at risk
ATRIAL FIBRILLATION	CARDIAC DISORDERS	MedDRA 17.1	EG00069 events54 affected374 at risk EG001110 events86 affected376 at risk
ATRIAL FLUTTER	CARDIAC DISORDERS	MedDRA 17.1	EG00010 events8 affected374 at risk EG00113 events12 affected376 at risk
ATRIAL SEPTAL DEFECT	CONGENITAL, FAMILIAL AND GENETIC DISORDERS	MedDRA 17.1	EG0002 events1 affected374 at risk EG0010 events0 affected376 at risk
ATRIAL TACHYCARDIA	CARDIAC DISORDERS	MedDRA 17.1	EG0006 events5 affected374 at risk EG0017 events7 affected376 at risk
ATRIOVENTRICULAR BLOCK SECOND DEGREE	CARDIAC DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
BENIGN PROSTATIC HYPERPLASIA	REPRODUCTIVE SYSTEM AND BREAST DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0012 events2 affected376 at risk
BENIGN SALIVARY GLAND NEOPLASM	NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
BILIARY COLIC	HEPATOBILIARY DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
BRACHYTHERAPY TO UTERUS	SURGICAL AND MEDICAL PROCEDURES	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
BRADYCARDIA	CARDIAC DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
BREAST CANCER	NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
BRONCHIAL NEOPLASM BENIGN	NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
BRONCHITIS	INFECTIONS AND INFESTATIONS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0011 events1 affected376 at risk
BURSITIS	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
CARCINOID TUMOUR OF THE CAECUM	NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
CARDIAC ABLATION	SURGICAL AND MEDICAL PROCEDURES	MedDRA 17.1	EG0001 events1 affected374 at risk EG0011 events1 affected376 at risk
CARDIAC FAILURE	CARDIAC DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
CARDIAC TAMPONADE	CARDIAC DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0014 events4 affected376 at risk
CEREBELLAR INFARCTION	NERVOUS SYSTEM DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
CEREBRAL HEMORRHAGE	NERVOUS SYSTEM DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
CERVICAL VERTEBRAL FRACTURE	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
CHEST PAIN	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
CHOKING	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
CHOLECYSTECTOMY	SURGICAL AND MEDICAL PROCEDURES	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
CHOLECYSTITIS	HEPATOBILIARY DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0011 events1 affected376 at risk
CHOLELITHIASIS	HEPATOBILIARY DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
CIRCULATORY COLLAPSE	VASCULAR DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
CONTRAST MEDIA REACTION	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
CONTUSION	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
CORONARY ARTERY DISEASE	CARDIAC DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0012 events2 affected376 at risk
CORONARY ARTERY STENOSIS	CARDIAC DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
CRITICAL ILLNESS POLYNEUROPATHY	NERVOUS SYSTEM DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
DACRYOSTENOSIS ACQUIRED	EYE DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
DEATH	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
DEVICE RELATED INFECTION	INFECTIONS AND INFESTATIONS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
DIABETIC GASTROPARESIS	GASTROINTESTINAL DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
DIARRHOEA	GASTROINTESTINAL DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
DISSOCIATIVE DISORDER	PSYCHIATRIC DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
DIVERTICULITIS	INFECTIONS AND INFESTATIONS	MedDRA 17.1	EG0003 events2 affected374 at risk EG0010 events0 affected376 at risk
DIZZINESS	NERVOUS SYSTEM DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0014 events4 affected376 at risk
DYSARTHRIA	NERVOUS SYSTEM DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
DYSPNEA	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	MedDRA 17.1	EG0007 events7 affected374 at risk EG0014 events4 affected376 at risk
DYSPNEA EXERTIONAL	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
DYSURIA	RENAL AND URINARY DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
ENTEROCOLITIS	GASTROINTESTINAL DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
EPIGASTRIC DISCOMFORT	GASTROINTESTINAL DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
EPILEPSY	NERVOUS SYSTEM DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
EXERTIONAL DYSPNOEA	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
EXOSTOSIS OF EXTERNAL EAR CANAL	EAR AND LABYRINTH DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
FACIAL BONES FRACTURE	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
FATIGUE	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
FEMORAL NECK FRACTURE	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
FRACTURE	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
GASTRITIS	GASTROINTESTINAL DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0012 events2 affected376 at risk
GASTROINTESTINAL HEMORRHAGE	GASTROINTESTINAL DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
GROIN PAIN	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
HEMATOCHEZIA	GASTROINTESTINAL DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
HEMATOMA	VASCULAR DISORDERS	MedDRA 17.1	EG0002 events2 affected374 at risk EG0016 events5 affected376 at risk
HEMATOMA EVACUATION	SURGICAL AND MEDICAL PROCEDURES	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
HEMATURIA	RENAL AND URINARY DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
HEMOPTYSIS	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0011 events1 affected376 at risk
HEMORRHAGE	VASCULAR DISORDERS	MedDRA 17.1	EG0004 events4 affected374 at risk EG0010 events0 affected376 at risk
HERNIA	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
HODGKIN'S DISEASE	NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
HOSPITALISATION	SURGICAL AND MEDICAL PROCEDURES	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
HYPERHIDROSIS	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
HYPERTENSION	VASCULAR DISORDERS	MedDRA 17.1	EG0003 events2 affected374 at risk EG0012 events2 affected376 at risk
HYPERTENSIVE CRISIS	VASCULAR DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
HYPERTENSIVE ENCEPHALOPATHY	NERVOUS SYSTEM DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
HYPOAESTHESIA	NERVOUS SYSTEM DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
HYPONATREMIA	METABOLISM AND NUTRITION DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
HYSTEROSALPINGO-OOPHORECTOMY	SURGICAL AND MEDICAL PROCEDURES	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
IMPAIRED GASTRIC EMPTYING	GASTROINTESTINAL DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	INFECTIONS AND INFESTATIONS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0012 events1 affected376 at risk
INTESTINAL PERFORATION	GASTROINTESTINAL DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
LARGE INTESTINE POLYP	GASTROINTESTINAL DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
LIP AND/OR ORAL CAVITY CANCER	NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)	MedDRA 17.1	EG0002 events1 affected374 at risk EG0010 events0 affected376 at risk
LOCAL SWELLING	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
MENIERE'S DISEASE	EAR AND LABYRINTH DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
METASTATIC NEOPLASM	NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
MICROLITHIASIS	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
MIGRAINE WITH AURA	NERVOUS SYSTEM DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
MULTIPLE SCLEROSIS	NERVOUS SYSTEM DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
MYOCARDIAL INFARCTION	CARDIAC DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
NAUSEA	GASTROINTESTINAL DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0011 events1 affected376 at risk
NEPHROLITHIASIS	RENAL AND URINARY DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
NODAL OSTEOARTHRITIS	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
OESOPHAGEAL ULCER	GASTROINTESTINAL DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
OPTIC NEURITIS	NERVOUS SYSTEM DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
OSTEOARTHRITIS	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	MedDRA 17.1	EG0002 events2 affected374 at risk EG0015 events5 affected376 at risk
PAIN	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
PAINFUL RESPIRATION	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
PALPITATIONS	CARDIAC DISORDERS	MedDRA 17.1	EG0004 events4 affected374 at risk EG00111 events9 affected376 at risk
PANCREATIC CARCINOMA	NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
PARAPARESIS	NERVOUS SYSTEM DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
PERICARDIAL EFFUSION	CARDIAC DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0012 events2 affected376 at risk
PERICARDITIS	CARDIAC DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0011 events1 affected376 at risk
PHARYNGEAL INFLAMMATION	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
PHRENIC NERVE PARALYSIS	NERVOUS SYSTEM DISORDERS	MedDRA 17.1	EG00010 events10 affected374 at risk EG0010 events0 affected376 at risk
PNEUMONIA	INFECTIONS AND INFESTATIONS	MedDRA 17.1	EG0005 events4 affected374 at risk EG0013 events3 affected376 at risk
PNEUMOTHORAX	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
POST PROCEDURAL COMPLICATION	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
POST PROCEDURAL HEMATOMA	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
POST PROCEDURAL HEMORRHAGE	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
POST PROCEDURAL STROKE	NERVOUS SYSTEM DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
PRESYNCOPE	NERVOUS SYSTEM DISORDERS	MedDRA 17.1	EG0002 events2 affected374 at risk EG0013 events3 affected376 at risk
PROCEDURAL DIZZINESS	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
PSORIASIS	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
PULMONARY CONGESTION	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
PULMONARY EMBOLISM	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
PULMONARY OEDEMA	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
PYREXIA	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0012 events2 affected376 at risk
RADIUS FRACTURE	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	MedDRA 17.1	EG0003 events2 affected374 at risk EG0010 events0 affected376 at risk
RECTAL LESION EXCISION	SURGICAL AND MEDICAL PROCEDURES	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
RENAL COLIC	RENAL AND URINARY DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
RENAL FAILURE ACUTE	RENAL AND URINARY DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
RESPIRATORY FAILURE	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
RESPIRATORY TRACT INFECTION	INFECTIONS AND INFESTATIONS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0011 events1 affected376 at risk
ROAD TRAFFIC ACCIDENT	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
ROTATOR CUFF SYNDROME	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
SEPSIS	INFECTIONS AND INFESTATIONS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
SICK SINUS SYNDROME	CARDIAC DISORDERS	MedDRA 17.1	EG0002 events2 affected374 at risk EG0011 events1 affected376 at risk
SJOGREN'S SYNDROME	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
SPINAL COLUMN INJURY	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
SPINAL FRACTURE	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
SPONTANEOUS HEMATOMA	BLOOD AND LYMPHATIC SYSTEM DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
STASIS SYNDROME	GASTROINTESTINAL DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
SUPRAVENTRICULAR EXTRASYSTOLES	CARDIAC DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0012 events2 affected376 at risk
SYNCOPE	NERVOUS SYSTEM DISORDERS	MedDRA 17.1	EG0002 events2 affected374 at risk EG0010 events0 affected376 at risk
SYNOVITIS	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
TACHYCARDIA	CARDIAC DISORDERS	MedDRA 17.1	EG0002 events2 affected374 at risk EG0012 events2 affected376 at risk
TENDON RUPTURE	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0011 events1 affected376 at risk
THORACOTOMY	SURGICAL AND MEDICAL PROCEDURES	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
THYROID CYST	ENDOCRINE DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
THYROID DISORDER	ENDOCRINE DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
THYROID NODULE	NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
TONSILLECTOMY	SURGICAL AND MEDICAL PROCEDURES	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
TONSILLITIS	INFECTIONS AND INFESTATIONS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
TOXIC NODULAR GOITRE	ENDOCRINE DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
TRANSIENT GLOBAL AMNESIA	NERVOUS SYSTEM DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
TRANSIENT ISCHEMIC ATTACK	NERVOUS SYSTEM DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0012 events2 affected376 at risk
URINARY BLADDER HEMORRHAGE	RENAL AND URINARY DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
URINARY TRACT INFECTION	INFECTIONS AND INFESTATIONS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
UTERINE PROLAPSE	REPRODUCTIVE SYSTEM AND BREAST DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
VAGINAL HEMORRHAGE	REPRODUCTIVE SYSTEM AND BREAST DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
VARICOSE VEIN	VASCULAR DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0011 events1 affected376 at risk
VARICOSE VEIN OPERATION	SURGICAL AND MEDICAL PROCEDURES	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
VASCULAR PSEUDOANEURYSM	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	MedDRA 17.1	EG0002 events2 affected374 at risk EG0018 events8 affected376 at risk
VASCULITIS	VASCULAR DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
VENTRICULAR FIBRILLATION	CARDIAC DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
VENTRICULAR TACHYCARDIA	CARDIAC DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0010 events0 affected376 at risk
VESSEL PERFORATION	VASCULAR DISORDERS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk
VISUAL IMPAIRMENT	EYE DISORDERS	MedDRA 17.1	EG0001 events1 affected374 at risk EG0011 events1 affected376 at risk
VOMITING	GASTROINTESTINAL DISORDERS	MedDRA 17.1	EG0003 events3 affected374 at risk EG0011 events1 affected376 at risk
WOUND INFECTION	INFECTIONS AND INFESTATIONS	MedDRA 17.1	EG0000 events0 affected374 at risk EG0011 events1 affected376 at risk

ID	Title	Description
BG000	Cryoballoon Ablation	Electrical isolation of the pulmonary veins: Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
BG001	Radiofrequency Ablation	Electrical isolation of pulmonary veins: Device:NaviStar® ThermoCool® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cryoballoon Ablation	Electrical isolation of the pulmonary veins: Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.			129	374	0	374
EG001	Radiofrequency Ablation	Electrical isolation of pulmonary veins: Device:NaviStar® ThermoCool® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.			158	376	0	376