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Trial record 5 of 7 for:    27042964 [PUBMED-IDS]

FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01490814
Recruitment Status : Completed
First Posted : December 13, 2011
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Symptomatic Paroxysmal Atrial Fibrillation (PAF)
Interventions Procedure: Electrical isolation of the pulmonary veins
Procedure: Electrical isolation of pulmonary veins
Enrollment 769
Recruitment Details  
Pre-assignment Details 769 subjects were enrolled; 7 subjects exited prior to randomization, 762 were randomized
Arm/Group Title Cryoballoon Ablation Radiofrequency Ablation
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 378 [1] 384 [2]
Completed 374 [3] 376 [4]
Not Completed 4 8
Reason Not Completed
Inclusion/Exclusion Criteria Violation             3             3
Physician Decision             1             0
Withdrawal by Subject             0             5
[1]
378 subjects randomized to Cryoballoon arm
[2]
384 subjects randomized to radiofrequency arm
[3]
374 received ablation
[4]
376 received ablation
Arm/Group Title Cryoballoon Ablation Radiofrequency Ablation Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 374 376 750
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 374 participants 376 participants 750 participants
59.9  (9.8) 60.1  (9.2) 60.0  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 374 participants 376 participants 750 participants
Female
153
  40.9%
140
  37.2%
293
  39.1%
Male
221
  59.1%
236
  62.8%
457
  60.9%
Years since first PAF diagnosis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 374 participants 376 participants 750 participants
4.6  (5.1) 4.7  (5.3) 4.6  (5.2)
1.Primary Outcome
Title 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
Hide Description Number of subjects reporting a primary efficacy endpoint
Time Frame 33 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects randomized and received an ablation procedure. Modified intent-to-treat (mITT) population.
Arm/Group Title Cryoballoon Ablation Radiofrequency Ablation
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 374 376
Measure Type: Count of Participants
Unit of Measure: Participants
138
  36.9%
143
  38.0%
2.Primary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 33 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects randomized and received an ablation procedure. Modified intent-to-treat (mITT) population.
Arm/Group Title Cryoballoon Ablation Radiofrequency Ablation
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 374 376
Measure Type: Count of Participants
Unit of Measure: Participants
No primary safety event
334
  89.3%
325
  86.4%
Death
2
   0.5%
0
   0.0%
All-cause stroke or TIA
2
   0.5%
2
   0.5%
Atrial Arrhythmia
8
   2.1%
13
   3.5%
Non-arrhythmia-related Serious Adverse Event
28
   7.5%
36
   9.6%
3.Secondary Outcome
Title All-cause Death
Hide Description [Not Specified]
Time Frame 33 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects randomized and received ablation. Modified intent-to-treat (mITT) population.
Arm/Group Title Cryoballoon Ablation Radiofrequency Ablation
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 374 376
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.5%
0
   0.0%
4.Secondary Outcome
Title Arrhythmia-related Death
Hide Description [Not Specified]
Time Frame 33 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects randomized and received an ablation procedure. Modified intent-to-treat (mITT) population.
Arm/Group Title Cryoballoon Ablation Radiofrequency Ablation
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 374 376
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Total Procedure Duration
Hide Description [Not Specified]
Time Frame Through the initial ablation procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects randomized and received ablation. Modified intent-to-treat (mITT) population.
Arm/Group Title Cryoballoon Ablation Radiofrequency Ablation
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 374 376
Mean (Standard Deviation)
Unit of Measure: minutes
124.4  (39.0) 140.9  (54.9)
6.Secondary Outcome
Title Total Time of Fluoroscopy
Hide Description [Not Specified]
Time Frame Fluoroscopy meter time through the initial ablation procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects randomized and received ablation procedure. Modified intent-to-treat (mITT) population
Arm/Group Title Cryoballoon Ablation Radiofrequency Ablation
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 374 376
Mean (Standard Deviation)
Unit of Measure: minutes
16.6  (17.8) 21.7  (13.9)
7.Secondary Outcome
Title Number of Subjects Reporting a Cardiovascular Hospitalization Over the Duration of the Study.
Hide Description [Not Specified]
Time Frame 33 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects randomized and received an ablation procedure. Modified intent-to-treat (mITT) population.
Arm/Group Title Cryoballoon Ablation Radiofrequency Ablation
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 374 376
Measure Type: Count of Participants
Unit of Measure: Participants
89
  23.8%
135
  35.9%
8.Secondary Outcome
Title Number of Cardiovascular Hospitalizations
Hide Description The total number of cardiovascular hospitalizations reported over the duration of the study.
Time Frame 33 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects randomized and received an ablation procedure. Modified intent-to-treat (mITT) population.
Arm/Group Title Cryoballoon Ablation Radiofrequency Ablation
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 374 376
Measure Type: Number
Unit of Measure: number of cardiovascular hospitalization
139 203
Time Frame The duration of the study. Mean follow-up was 1.5 years, maximum follow-up was 33 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cryoballoon Ablation Radiofrequency Ablation
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Cryoballoon Ablation Radiofrequency Ablation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cryoballoon Ablation Radiofrequency Ablation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   129/374 (34.49%)      158/376 (42.02%)    
Blood and lymphatic system disorders     
SPONTANEOUS HEMATOMA  0/374 (0.00%)  0 1/376 (0.27%)  1
Cardiac disorders     
ANGINA PECTORIS  1/374 (0.27%)  1 0/376 (0.00%)  0
ANGINA UNSTABLE  1/374 (0.27%)  1 0/376 (0.00%)  0
ATRIAL FIBRILLATION  54/374 (14.44%)  69 86/376 (22.87%)  110
ATRIAL FLUTTER  8/374 (2.14%)  10 12/376 (3.19%)  13
ATRIAL TACHYCARDIA  5/374 (1.34%)  6 7/376 (1.86%)  7
ATRIOVENTRICULAR BLOCK SECOND DEGREE  0/374 (0.00%)  0 1/376 (0.27%)  1
BRADYCARDIA  0/374 (0.00%)  0 1/376 (0.27%)  1
CARDIAC FAILURE  0/374 (0.00%)  0 1/376 (0.27%)  1
CARDIAC TAMPONADE  1/374 (0.27%)  1 4/376 (1.06%)  4
CORONARY ARTERY DISEASE  1/374 (0.27%)  1 2/376 (0.53%)  2
CORONARY ARTERY STENOSIS  1/374 (0.27%)  1 0/376 (0.00%)  0
MYOCARDIAL INFARCTION  0/374 (0.00%)  0 1/376 (0.27%)  1
PALPITATIONS  4/374 (1.07%)  4 9/376 (2.39%)  11
PERICARDIAL EFFUSION  1/374 (0.27%)  1 2/376 (0.53%)  2
PERICARDITIS  1/374 (0.27%)  1 1/376 (0.27%)  1
SICK SINUS SYNDROME  2/374 (0.53%)  2 1/376 (0.27%)  1
SUPRAVENTRICULAR EXTRASYSTOLES  1/374 (0.27%)  1 2/376 (0.53%)  2
TACHYCARDIA  2/374 (0.53%)  2 2/376 (0.53%)  2
VENTRICULAR FIBRILLATION  0/374 (0.00%)  0 1/376 (0.27%)  1
VENTRICULAR TACHYCARDIA  1/374 (0.27%)  1 0/376 (0.00%)  0
Congenital, familial and genetic disorders     
ATRIAL SEPTAL DEFECT  1/374 (0.27%)  2 0/376 (0.00%)  0
Ear and labyrinth disorders     
EXOSTOSIS OF EXTERNAL EAR CANAL  1/374 (0.27%)  1 0/376 (0.00%)  0
MENIERE'S DISEASE  0/374 (0.00%)  0 1/376 (0.27%)  1
Endocrine disorders     
THYROID CYST  0/374 (0.00%)  0 1/376 (0.27%)  1
THYROID DISORDER  1/374 (0.27%)  1 0/376 (0.00%)  0
TOXIC NODULAR GOITRE  1/374 (0.27%)  1 0/376 (0.00%)  0
Eye disorders     
DACRYOSTENOSIS ACQUIRED  1/374 (0.27%)  1 0/376 (0.00%)  0
VISUAL IMPAIRMENT  1/374 (0.27%)  1 1/376 (0.27%)  1
Gastrointestinal disorders     
ABDOMINAL PAIN UPPER  2/374 (0.53%)  2 0/376 (0.00%)  0
DIABETIC GASTROPARESIS  1/374 (0.27%)  1 0/376 (0.00%)  0
DIARRHOEA  1/374 (0.27%)  1 0/376 (0.00%)  0
ENTEROCOLITIS  1/374 (0.27%)  1 0/376 (0.00%)  0
EPIGASTRIC DISCOMFORT  0/374 (0.00%)  0 1/376 (0.27%)  1
GASTRITIS  0/374 (0.00%)  0 2/376 (0.53%)  2
GASTROINTESTINAL HEMORRHAGE  0/374 (0.00%)  0 1/376 (0.27%)  1
HEMATOCHEZIA  0/374 (0.00%)  0 1/376 (0.27%)  1
IMPAIRED GASTRIC EMPTYING  1/374 (0.27%)  1 0/376 (0.00%)  0
INTESTINAL PERFORATION  1/374 (0.27%)  1 0/376 (0.00%)  0
LARGE INTESTINE POLYP  0/374 (0.00%)  0 1/376 (0.27%)  1
NAUSEA  1/374 (0.27%)  1 1/376 (0.27%)  1
OESOPHAGEAL ULCER  1/374 (0.27%)  1 0/376 (0.00%)  0
STASIS SYNDROME  1/374 (0.27%)  1 0/376 (0.00%)  0
VOMITING  3/374 (0.80%)  3 1/376 (0.27%)  1
General disorders     
ADVERSE DRUG REACTION  0/374 (0.00%)  0 1/376 (0.27%)  1
ASTHENIA  2/374 (0.53%)  2 2/376 (0.53%)  2
CHEST PAIN  0/374 (0.00%)  0 1/376 (0.27%)  1
DEATH  1/374 (0.27%)  1 0/376 (0.00%)  0
FATIGUE  1/374 (0.27%)  1 0/376 (0.00%)  0
HERNIA  1/374 (0.27%)  1 0/376 (0.00%)  0
LOCAL SWELLING  0/374 (0.00%)  0 1/376 (0.27%)  1
MICROLITHIASIS  1/374 (0.27%)  1 0/376 (0.00%)  0
PAIN  0/374 (0.00%)  0 1/376 (0.27%)  1
PYREXIA  0/374 (0.00%)  0 2/376 (0.53%)  2
Hepatobiliary disorders     
BILIARY COLIC  0/374 (0.00%)  0 1/376 (0.27%)  1
CHOLECYSTITIS  1/374 (0.27%)  1 1/376 (0.27%)  1
CHOLELITHIASIS  0/374 (0.00%)  0 1/376 (0.27%)  1
Infections and infestations     
BRONCHITIS  1/374 (0.27%)  1 1/376 (0.27%)  1
DEVICE RELATED INFECTION  0/374 (0.00%)  0 1/376 (0.27%)  1
DIVERTICULITIS  2/374 (0.53%)  3 0/376 (0.00%)  0
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE  0/374 (0.00%)  0 1/376 (0.27%)  2
PNEUMONIA  4/374 (1.07%)  5 3/376 (0.80%)  3
RESPIRATORY TRACT INFECTION  1/374 (0.27%)  1 1/376 (0.27%)  1
SEPSIS  1/374 (0.27%)  1 0/376 (0.00%)  0
TONSILLITIS  0/374 (0.00%)  0 1/376 (0.27%)  1
URINARY TRACT INFECTION  0/374 (0.00%)  0 1/376 (0.27%)  1
WOUND INFECTION  0/374 (0.00%)  0 1/376 (0.27%)  1
Injury, poisoning and procedural complications     
ACCIDENT  1/374 (0.27%)  1 0/376 (0.00%)  0
ANESTHETIC COMPLICATION PULMONARY  1/374 (0.27%)  1 0/376 (0.00%)  0
CERVICAL VERTEBRAL FRACTURE  0/374 (0.00%)  0 1/376 (0.27%)  1
CONTRAST MEDIA REACTION  0/374 (0.00%)  0 1/376 (0.27%)  1
CONTUSION  0/374 (0.00%)  0 1/376 (0.27%)  1
FACIAL BONES FRACTURE  1/374 (0.27%)  1 0/376 (0.00%)  0
FEMORAL NECK FRACTURE  0/374 (0.00%)  0 1/376 (0.27%)  1
FRACTURE  0/374 (0.00%)  0 1/376 (0.27%)  1
POST PROCEDURAL COMPLICATION  0/374 (0.00%)  0 1/376 (0.27%)  1
POST PROCEDURAL HEMATOMA  1/374 (0.27%)  1 0/376 (0.00%)  0
POST PROCEDURAL HEMORRHAGE  1/374 (0.27%)  1 0/376 (0.00%)  0
PROCEDURAL DIZZINESS  1/374 (0.27%)  1 0/376 (0.00%)  0
RADIUS FRACTURE  2/374 (0.53%)  3 0/376 (0.00%)  0
ROAD TRAFFIC ACCIDENT  0/374 (0.00%)  0 1/376 (0.27%)  1
SPINAL COLUMN INJURY  1/374 (0.27%)  1 0/376 (0.00%)  0
SPINAL FRACTURE  0/374 (0.00%)  0 1/376 (0.27%)  1
TENDON RUPTURE  1/374 (0.27%)  1 1/376 (0.27%)  1
VASCULAR PSEUDOANEURYSM  2/374 (0.53%)  2 8/376 (2.13%)  8
Investigations     
ARTERIOGRAM CORONARY  0/374 (0.00%)  0 1/376 (0.27%)  1
Metabolism and nutrition disorders     
HYPONATREMIA  1/374 (0.27%)  1 0/376 (0.00%)  0
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  0/374 (0.00%)  0 1/376 (0.27%)  1
BURSITIS  1/374 (0.27%)  1 0/376 (0.00%)  0
GROIN PAIN  0/374 (0.00%)  0 1/376 (0.27%)  1
NODAL OSTEOARTHRITIS  1/374 (0.27%)  1 0/376 (0.00%)  0
OSTEOARTHRITIS  2/374 (0.53%)  2 5/376 (1.33%)  5
ROTATOR CUFF SYNDROME  1/374 (0.27%)  1 0/376 (0.00%)  0
SJOGREN'S SYNDROME  1/374 (0.27%)  1 0/376 (0.00%)  0
SYNOVITIS  0/374 (0.00%)  0 1/376 (0.27%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
BENIGN SALIVARY GLAND NEOPLASM  1/374 (0.27%)  1 0/376 (0.00%)  0
BREAST CANCER  0/374 (0.00%)  0 1/376 (0.27%)  1
BRONCHIAL NEOPLASM BENIGN  1/374 (0.27%)  1 0/376 (0.00%)  0
CARCINOID TUMOUR OF THE CAECUM  0/374 (0.00%)  0 1/376 (0.27%)  1
HODGKIN'S DISEASE  0/374 (0.00%)  0 1/376 (0.27%)  1
LIP AND/OR ORAL CAVITY CANCER  1/374 (0.27%)  2 0/376 (0.00%)  0
METASTATIC NEOPLASM  1/374 (0.27%)  1 0/376 (0.00%)  0
PANCREATIC CARCINOMA  1/374 (0.27%)  1 0/376 (0.00%)  0
THYROID NODULE  0/374 (0.00%)  0 1/376 (0.27%)  1
Nervous system disorders     
CEREBELLAR INFARCTION  0/374 (0.00%)  0 1/376 (0.27%)  1
CEREBRAL HEMORRHAGE  0/374 (0.00%)  0 1/376 (0.27%)  1
CRITICAL ILLNESS POLYNEUROPATHY  1/374 (0.27%)  1 0/376 (0.00%)  0
DIZZINESS  1/374 (0.27%)  1 4/376 (1.06%)  4
DYSARTHRIA  1/374 (0.27%)  1 0/376 (0.00%)  0
EPILEPSY  1/374 (0.27%)  1 0/376 (0.00%)  0
HYPERTENSIVE ENCEPHALOPATHY  1/374 (0.27%)  1 0/376 (0.00%)  0
HYPOAESTHESIA  0/374 (0.00%)  0 1/376 (0.27%)  1
MIGRAINE WITH AURA  0/374 (0.00%)  0 1/376 (0.27%)  1
MULTIPLE SCLEROSIS  1/374 (0.27%)  1 0/376 (0.00%)  0
OPTIC NEURITIS  0/374 (0.00%)  0 1/376 (0.27%)  1
PARAPARESIS  1/374 (0.27%)  1 0/376 (0.00%)  0
PHRENIC NERVE PARALYSIS  10/374 (2.67%)  10 0/376 (0.00%)  0
POST PROCEDURAL STROKE  1/374 (0.27%)  1 0/376 (0.00%)  0
PRESYNCOPE  2/374 (0.53%)  2 3/376 (0.80%)  3
SYNCOPE  2/374 (0.53%)  2 0/376 (0.00%)  0
TRANSIENT GLOBAL AMNESIA  0/374 (0.00%)  0 1/376 (0.27%)  1
TRANSIENT ISCHEMIC ATTACK  1/374 (0.27%)  1 2/376 (0.53%)  2
Psychiatric disorders     
ANXIETY  1/374 (0.27%)  1 0/376 (0.00%)  0
DISSOCIATIVE DISORDER  1/374 (0.27%)  1 0/376 (0.00%)  0
Renal and urinary disorders     
DYSURIA  0/374 (0.00%)  0 1/376 (0.27%)  1
HEMATURIA  0/374 (0.00%)  0 1/376 (0.27%)  1
NEPHROLITHIASIS  0/374 (0.00%)  0 1/376 (0.27%)  1
RENAL COLIC  0/374 (0.00%)  0 1/376 (0.27%)  1
RENAL FAILURE ACUTE  1/374 (0.27%)  1 0/376 (0.00%)  0
URINARY BLADDER HEMORRHAGE  0/374 (0.00%)  0 1/376 (0.27%)  1
Reproductive system and breast disorders     
BENIGN PROSTATIC HYPERPLASIA  0/374 (0.00%)  0 2/376 (0.53%)  2
UTERINE PROLAPSE  0/374 (0.00%)  0 1/376 (0.27%)  1
VAGINAL HEMORRHAGE  0/374 (0.00%)  0 1/376 (0.27%)  1
Respiratory, thoracic and mediastinal disorders     
ASPIRATION  0/374 (0.00%)  0 1/376 (0.27%)  1
CHOKING  1/374 (0.27%)  1 0/376 (0.00%)  0
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  0/374 (0.00%)  0 1/376 (0.27%)  1
DYSPNEA  7/374 (1.87%)  7 4/376 (1.06%)  4
DYSPNEA EXERTIONAL  0/374 (0.00%)  0 1/376 (0.27%)  1
EXERTIONAL DYSPNOEA  0/374 (0.00%)  0 1/376 (0.27%)  1
HEMOPTYSIS  1/374 (0.27%)  1 1/376 (0.27%)  1
PAINFUL RESPIRATION  1/374 (0.27%)  1 0/376 (0.00%)  0
PHARYNGEAL INFLAMMATION  0/374 (0.00%)  0 1/376 (0.27%)  1
PNEUMOTHORAX  0/374 (0.00%)  0 1/376 (0.27%)  1
PULMONARY CONGESTION  0/374 (0.00%)  0 1/376 (0.27%)  1
PULMONARY EMBOLISM  0/374 (0.00%)  0 1/376 (0.27%)  1
PULMONARY OEDEMA  1/374 (0.27%)  1 0/376 (0.00%)  0
RESPIRATORY FAILURE  1/374 (0.27%)  1 0/376 (0.00%)  0
Skin and subcutaneous tissue disorders     
HYPERHIDROSIS  0/374 (0.00%)  0 1/376 (0.27%)  1
PSORIASIS  0/374 (0.00%)  0 1/376 (0.27%)  1
Surgical and medical procedures     
BRACHYTHERAPY TO UTERUS  1/374 (0.27%)  1 0/376 (0.00%)  0
CARDIAC ABLATION  1/374 (0.27%)  1 1/376 (0.27%)  1
CHOLECYSTECTOMY  0/374 (0.00%)  0 1/376 (0.27%)  1
HEMATOMA EVACUATION  0/374 (0.00%)  0 1/376 (0.27%)  1
HOSPITALISATION  0/374 (0.00%)  0 1/376 (0.27%)  1
HYSTEROSALPINGO-OOPHORECTOMY  1/374 (0.27%)  1 0/376 (0.00%)  0
RECTAL LESION EXCISION  1/374 (0.27%)  1 0/376 (0.00%)  0
THORACOTOMY  1/374 (0.27%)  1 0/376 (0.00%)  0
TONSILLECTOMY  0/374 (0.00%)  0 1/376 (0.27%)  1
VARICOSE VEIN OPERATION  0/374 (0.00%)  0 1/376 (0.27%)  1
Vascular disorders     
AORTIC ANEURYSM  1/374 (0.27%)  1 1/376 (0.27%)  1
AORTIC DISSECTION  1/374 (0.27%)  2 0/376 (0.00%)  0
ARTERIOVENOUS FISTULA  0/374 (0.00%)  0 3/376 (0.80%)  3
ARTERITIS  1/374 (0.27%)  1 0/376 (0.00%)  0
CIRCULATORY COLLAPSE  1/374 (0.27%)  1 0/376 (0.00%)  0
HEMATOMA  2/374 (0.53%)  2 5/376 (1.33%)  6
HEMORRHAGE  4/374 (1.07%)  4 0/376 (0.00%)  0
HYPERTENSION  2/374 (0.53%)  3 2/376 (0.53%)  2
HYPERTENSIVE CRISIS  1/374 (0.27%)  1 0/376 (0.00%)  0
VARICOSE VEIN  1/374 (0.27%)  1 1/376 (0.27%)  1
VASCULITIS  1/374 (0.27%)  1 0/376 (0.00%)  0
VESSEL PERFORATION  0/374 (0.00%)  0 1/376 (0.27%)  1
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cryoballoon Ablation Radiofrequency Ablation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/374 (0.00%)      0/376 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Ralf Meyer
Organization: Medtronic
Phone: +49215981490
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier: NCT01490814     History of Changes
Other Study ID Numbers: FI-123
First Submitted: December 6, 2011
First Posted: December 13, 2011
Results First Submitted: February 16, 2017
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018