FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation
Sponsor
Medtronic Atrial Fibrillation Solutions (Industry)
Overall Status
Completed
CT.gov ID
NCT01490814
Collaborator
Medtronic (Industry)
769
19
2
49
40.5
0.8
Study Details
Study Description
Brief Summary
Comparing 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 paroxysmal atrial fibrillation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The purpose of this randomized clinical trial is to compare the efficacy and safety of isolating the PVs with either the cryoballoon or a RF ablation technique with a ThermoCool catheter, a system which can be regarded as standard for ablation. In total 762 patients with paroxysmal atrial fibrillation has been randomized for either radiofrequency (RF) or cryoballoon. With both techniques, PV isolation will be performed. Primary end point of the trial is the time to first recurrence of atrial arrhythmias or prescription of anti-arrhythmic drugs after a blanking period of three months. Treatment success will be evaluated by using weekly electrocardiography (ECG) monitoring (transtelephonic transmission/Tele-ECG) and using Holter electrocardiograms.
Study Design
Study Type:
Interventional
Actual Enrollment
:
769 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Controlled, Prospective, Non-Inferiority, Parallel-Group, Randomised, Interventional, Open, Blinded Outcome Assessment (PROBE-Design), Multi-centre Trial, Comparing Efficacy and Safety of Isolation of the PVs With a Cryoballoon Catheter vs a Radiofrequency Ablation With a ThermoCool Catheter in Patients With PAF
Study Start Date
:
Dec 1, 2011
Actual Primary Completion Date
:
Jan 1, 2016
Actual Study Completion Date
:
Jan 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Cryoballoon ablation
|
Procedure: 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.
|
| Active Comparator: Radiofrequency ablation
|
Procedure: 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.
|
Outcome Measures
Primary Outcome Measures
- 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 [33 months]
Number of subjects reporting a primary efficacy endpoint
- 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]
Secondary Outcome Measures
- All-cause Death [33 months]
- Arrhythmia-related Death [33 months]
- Total Procedure Duration [Through the initial ablation procedure]
- Total Time of Fluoroscopy [Fluoroscopy meter time through the initial ablation procedure]
- Number of Subjects Reporting a Cardiovascular Hospitalization Over the Duration of the Study. [33 months]
- Number of Cardiovascular Hospitalizations [33 months]
The total number of cardiovascular hospitalizations reported over the duration of the study.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Na Homolce Hospital, Cardiology | Prague | Czechia | 515030 | |
| 2 | Hospital Henri Mondor CHU, Service de Cardiologie | Créteil | France | 94010 | |
| 3 | CHU Lyon, Départment de Rythmologie, Hospital Cardiologique Pradel | Lyon | France | 69677 | |
| 4 | Centre Chirurgical Ambroise Paré | Neuilly Sur Seine | France | 92200 | |
| 5 | La Clinique Pasteur, 45 Avenue de Lombez | Toulouse | France | 31076 | |
| 6 | Herz-Zentrum Bad Krozingen | Bad Krozingen | Germany | 79189 | |
| 7 | Klinik für Kardiologie II mit interventioneller Elektrophysiologie | Bad Neustadt/Saale | Germany | 97616 | |
| 8 | Cardioangiologisches Centrum Bethanien - CCB | Frankfurt | Germany | 60431 | |
| 9 | Universitätsklinikum Greifswald Elektrophysiologie | Greifswald | Germany | 17475 | |
| 10 | Asklepios Klinik St. Georg | Hamburg | Germany | 20099 | |
| 11 | Herz-Zentrum-Bodensee Konstanz | Konstanz | Germany | 78464 | |
| 12 | Semmelweis University of Medicine, Kardiovaskuläres Zentrum | Budapest | Hungary | 1122 | |
| 13 | Cardiac Arrhythmia Research Centre Department of Cardiovascular Medicine Centro Cardiologico Monzino University of Milan | Milan | Italy | 20138 | |
| 14 | Isala Klinieken loc. Weezenlanden Diagram Clinical Resarch | Zwolle | Netherlands | 8011 | |
| 15 | Hospital Clinic, University of Barcelona | Barcelona | Spain | 08036 | |
| 16 | Arrhythmia Unit Hospital Clinico San Carlos | Madrid | Spain | 28040 | |
| 17 | Hospital Universitario Virgen de la Victoria, Department of Cardiology, Campus Teatinos sn | Malaga | Spain | 29010 | |
| 18 | Hospital Clinico Universtitario, Cardiology Department Arrhythmia Unit | Valencia | Spain | 46014 | |
| 19 | Universitätsspital Basel, Elektrophysiologie/ Kardiologie | Basel | Switzerland | 4031 |
Sponsors and Collaborators
- Medtronic Atrial Fibrillation Solutions
- Medtronic
Investigators
- Principal Investigator: Karl-Heinz Kuck, Prof. Dr., Asklepios Klinikum St. Georg
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- 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.
- Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation.
- FIRE AND ICE: LBCT ACC
Publications
Responsible Party:
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT01490814
Other Study ID Numbers:
- FI-123
First Posted:
Dec 13, 2011
Last Update Posted:
Nov 2, 2018
Last Verified:
Mar 1, 2018
Keywords provided by Medtronic Atrial Fibrillation Solutions
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 769 subjects were enrolled; 7 subjects exited prior to randomization, 762 were randomized |
| Arm/Group Title | Cryoballoon Ablation | Radiofrequency Ablation |
|---|---|---|
| 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 | 384 |
| COMPLETED | 374 | 376 |
| NOT COMPLETED | 4 | 8 |
Baseline Characteristics
| Arm/Group Title | Cryoballoon Ablation | Radiofrequency Ablation | Total |
|---|---|---|---|
| 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 Participants | 374 | 376 | 750 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
59.9
(9.8)
|
60.1
(9.2)
|
60.0
(9.5)
|
| Sex: Female, Male (Count of 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 (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
4.6
(5.1)
|
4.7
(5.3)
|
4.6
(5.2)
|
Outcome Measures
| 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 |
|---|---|
| Description | Number of subjects reporting a primary efficacy endpoint |
| Time Frame | 33 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects randomized and received an ablation procedure. Modified intent-to-treat (mITT) population. |
| Arm/Group Title | Cryoballoon Ablation | Radiofrequency Ablation |
|---|---|---|
| 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. |
| Measure Participants | 374 | 376 |
| Count of Participants [Participants] |
138
36.9%
|
143
38%
|
| 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. |
|---|---|
| Description | |
| Time Frame | 33 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects randomized and received an ablation procedure. Modified intent-to-treat (mITT) population. |
| Arm/Group Title | Cryoballoon Ablation | Radiofrequency Ablation |
|---|---|---|
| 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. |
| Measure Participants | 374 | 376 |
| No primary safety event |
334
89.3%
|
325
86.4%
|
| Death |
2
0.5%
|
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%
|
| Title | All-cause Death |
|---|---|
| Description | |
| Time Frame | 33 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects randomized and received ablation. Modified intent-to-treat (mITT) population. |
| Arm/Group Title | Cryoballoon Ablation | Radiofrequency Ablation |
|---|---|---|
| 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. |
| Measure Participants | 374 | 376 |
| Count of Participants [Participants] |
2
0.5%
|
0
0%
|
| Title | Arrhythmia-related Death |
|---|---|
| Description | |
| Time Frame | 33 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects randomized and received an ablation procedure. Modified intent-to-treat (mITT) population. |
| Arm/Group Title | Cryoballoon Ablation | Radiofrequency Ablation |
|---|---|---|
| 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. |
| Measure Participants | 374 | 376 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Total Procedure Duration |
|---|---|
| Description | |
| Time Frame | Through the initial ablation procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects randomized and received ablation. Modified intent-to-treat (mITT) population. |
| Arm/Group Title | Cryoballoon Ablation | Radiofrequency Ablation |
|---|---|---|
| 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. |
| Measure Participants | 374 | 376 |
| Mean (Standard Deviation) [minutes] |
124.4
(39.0)
|
140.9
(54.9)
|
| Title | Total Time of Fluoroscopy |
|---|---|
| Description | |
| Time Frame | Fluoroscopy meter time through the initial ablation procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects randomized and received ablation procedure. Modified intent-to-treat (mITT) population |
| Arm/Group Title | Cryoballoon Ablation | Radiofrequency Ablation |
|---|---|---|
| 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. |
| Measure Participants | 374 | 376 |
| Mean (Standard Deviation) [minutes] |
16.6
(17.8)
|
21.7
(13.9)
|
| Title | Number of Subjects Reporting a Cardiovascular Hospitalization Over the Duration of the Study. |
|---|---|
| Description | |
| Time Frame | 33 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects randomized and received an ablation procedure. Modified intent-to-treat (mITT) population. |
| Arm/Group Title | Cryoballoon Ablation | Radiofrequency Ablation |
|---|---|---|
| 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. |
| Measure Participants | 374 | 376 |
| Count of Participants [Participants] |
89
23.8%
|
135
35.9%
|
| Title | Number of Cardiovascular Hospitalizations |
|---|---|
| Description | The total number of cardiovascular hospitalizations reported over the duration of the study. |
| Time Frame | 33 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects randomized and received an ablation procedure. Modified intent-to-treat (mITT) population. |
| Arm/Group Title | Cryoballoon Ablation | Radiofrequency Ablation |
|---|---|---|
| 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. |
| Measure Participants | 374 | 376 |
| Number [number of cardiovascular hospitalization] |
139
|
203
|
Adverse Events
| Time Frame | The duration of the study. Mean follow-up was 1.5 years, maximum follow-up was 33 months. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Cryoballoon Ablation | Radiofrequency Ablation | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Cryoballoon Ablation | Radiofrequency Ablation | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 129/374 (34.5%) | 158/376 (42%) | ||
| Blood and lymphatic system disorders | ||||
| SPONTANEOUS HEMATOMA | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| Cardiac disorders | ||||
| ANGINA PECTORIS | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| ANGINA UNSTABLE | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| ATRIAL FIBRILLATION | 54/374 (14.4%) | 69 | 86/376 (22.9%) | 110 |
| ATRIAL FLUTTER | 8/374 (2.1%) | 10 | 12/376 (3.2%) | 13 |
| ATRIAL TACHYCARDIA | 5/374 (1.3%) | 6 | 7/376 (1.9%) | 7 |
| ATRIOVENTRICULAR BLOCK SECOND DEGREE | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| BRADYCARDIA | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| CARDIAC FAILURE | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| CARDIAC TAMPONADE | 1/374 (0.3%) | 1 | 4/376 (1.1%) | 4 |
| CORONARY ARTERY DISEASE | 1/374 (0.3%) | 1 | 2/376 (0.5%) | 2 |
| CORONARY ARTERY STENOSIS | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| MYOCARDIAL INFARCTION | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| PALPITATIONS | 4/374 (1.1%) | 4 | 9/376 (2.4%) | 11 |
| PERICARDIAL EFFUSION | 1/374 (0.3%) | 1 | 2/376 (0.5%) | 2 |
| PERICARDITIS | 1/374 (0.3%) | 1 | 1/376 (0.3%) | 1 |
| SICK SINUS SYNDROME | 2/374 (0.5%) | 2 | 1/376 (0.3%) | 1 |
| SUPRAVENTRICULAR EXTRASYSTOLES | 1/374 (0.3%) | 1 | 2/376 (0.5%) | 2 |
| TACHYCARDIA | 2/374 (0.5%) | 2 | 2/376 (0.5%) | 2 |
| VENTRICULAR FIBRILLATION | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| VENTRICULAR TACHYCARDIA | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||
| ATRIAL SEPTAL DEFECT | 1/374 (0.3%) | 2 | 0/376 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| EXOSTOSIS OF EXTERNAL EAR CANAL | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| MENIERE'S DISEASE | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| Endocrine disorders | ||||
| THYROID CYST | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| THYROID DISORDER | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| TOXIC NODULAR GOITRE | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| Eye disorders | ||||
| DACRYOSTENOSIS ACQUIRED | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| VISUAL IMPAIRMENT | 1/374 (0.3%) | 1 | 1/376 (0.3%) | 1 |
| Gastrointestinal disorders | ||||
| ABDOMINAL PAIN UPPER | 2/374 (0.5%) | 2 | 0/376 (0%) | 0 |
| DIABETIC GASTROPARESIS | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| DIARRHOEA | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| ENTEROCOLITIS | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| EPIGASTRIC DISCOMFORT | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| GASTRITIS | 0/374 (0%) | 0 | 2/376 (0.5%) | 2 |
| GASTROINTESTINAL HEMORRHAGE | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| HEMATOCHEZIA | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| IMPAIRED GASTRIC EMPTYING | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| INTESTINAL PERFORATION | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| LARGE INTESTINE POLYP | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| NAUSEA | 1/374 (0.3%) | 1 | 1/376 (0.3%) | 1 |
| OESOPHAGEAL ULCER | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| STASIS SYNDROME | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| VOMITING | 3/374 (0.8%) | 3 | 1/376 (0.3%) | 1 |
| General disorders | ||||
| ADVERSE DRUG REACTION | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| ASTHENIA | 2/374 (0.5%) | 2 | 2/376 (0.5%) | 2 |
| CHEST PAIN | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| DEATH | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| FATIGUE | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| HERNIA | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| LOCAL SWELLING | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| MICROLITHIASIS | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| PAIN | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| PYREXIA | 0/374 (0%) | 0 | 2/376 (0.5%) | 2 |
| Hepatobiliary disorders | ||||
| BILIARY COLIC | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| CHOLECYSTITIS | 1/374 (0.3%) | 1 | 1/376 (0.3%) | 1 |
| CHOLELITHIASIS | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| Infections and infestations | ||||
| BRONCHITIS | 1/374 (0.3%) | 1 | 1/376 (0.3%) | 1 |
| DEVICE RELATED INFECTION | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| DIVERTICULITIS | 2/374 (0.5%) | 3 | 0/376 (0%) | 0 |
| INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | 0/374 (0%) | 0 | 1/376 (0.3%) | 2 |
| PNEUMONIA | 4/374 (1.1%) | 5 | 3/376 (0.8%) | 3 |
| RESPIRATORY TRACT INFECTION | 1/374 (0.3%) | 1 | 1/376 (0.3%) | 1 |
| SEPSIS | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| TONSILLITIS | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| URINARY TRACT INFECTION | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| WOUND INFECTION | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| Injury, poisoning and procedural complications | ||||
| ACCIDENT | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| ANESTHETIC COMPLICATION PULMONARY | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| CERVICAL VERTEBRAL FRACTURE | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| CONTRAST MEDIA REACTION | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| CONTUSION | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| FACIAL BONES FRACTURE | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| FEMORAL NECK FRACTURE | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| FRACTURE | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| POST PROCEDURAL COMPLICATION | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| POST PROCEDURAL HEMATOMA | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| POST PROCEDURAL HEMORRHAGE | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| PROCEDURAL DIZZINESS | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| RADIUS FRACTURE | 2/374 (0.5%) | 3 | 0/376 (0%) | 0 |
| ROAD TRAFFIC ACCIDENT | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| SPINAL COLUMN INJURY | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| SPINAL FRACTURE | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| TENDON RUPTURE | 1/374 (0.3%) | 1 | 1/376 (0.3%) | 1 |
| VASCULAR PSEUDOANEURYSM | 2/374 (0.5%) | 2 | 8/376 (2.1%) | 8 |
| Investigations | ||||
| ARTERIOGRAM CORONARY | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| Metabolism and nutrition disorders | ||||
| HYPONATREMIA | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| ARTHRALGIA | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| BURSITIS | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| GROIN PAIN | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| NODAL OSTEOARTHRITIS | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| OSTEOARTHRITIS | 2/374 (0.5%) | 2 | 5/376 (1.3%) | 5 |
| ROTATOR CUFF SYNDROME | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| SJOGREN'S SYNDROME | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| SYNOVITIS | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| BENIGN SALIVARY GLAND NEOPLASM | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| BREAST CANCER | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| BRONCHIAL NEOPLASM BENIGN | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| CARCINOID TUMOUR OF THE CAECUM | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| HODGKIN'S DISEASE | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| LIP AND/OR ORAL CAVITY CANCER | 1/374 (0.3%) | 2 | 0/376 (0%) | 0 |
| METASTATIC NEOPLASM | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| PANCREATIC CARCINOMA | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| THYROID NODULE | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| Nervous system disorders | ||||
| CEREBELLAR INFARCTION | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| CEREBRAL HEMORRHAGE | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| CRITICAL ILLNESS POLYNEUROPATHY | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| DIZZINESS | 1/374 (0.3%) | 1 | 4/376 (1.1%) | 4 |
| DYSARTHRIA | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| EPILEPSY | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| HYPERTENSIVE ENCEPHALOPATHY | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| HYPOAESTHESIA | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| MIGRAINE WITH AURA | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| MULTIPLE SCLEROSIS | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| OPTIC NEURITIS | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| PARAPARESIS | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| PHRENIC NERVE PARALYSIS | 10/374 (2.7%) | 10 | 0/376 (0%) | 0 |
| POST PROCEDURAL STROKE | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| PRESYNCOPE | 2/374 (0.5%) | 2 | 3/376 (0.8%) | 3 |
| SYNCOPE | 2/374 (0.5%) | 2 | 0/376 (0%) | 0 |
| TRANSIENT GLOBAL AMNESIA | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| TRANSIENT ISCHEMIC ATTACK | 1/374 (0.3%) | 1 | 2/376 (0.5%) | 2 |
| Psychiatric disorders | ||||
| ANXIETY | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| DISSOCIATIVE DISORDER | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| Renal and urinary disorders | ||||
| DYSURIA | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| HEMATURIA | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| NEPHROLITHIASIS | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| RENAL COLIC | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| RENAL FAILURE ACUTE | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| URINARY BLADDER HEMORRHAGE | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| Reproductive system and breast disorders | ||||
| BENIGN PROSTATIC HYPERPLASIA | 0/374 (0%) | 0 | 2/376 (0.5%) | 2 |
| UTERINE PROLAPSE | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| VAGINAL HEMORRHAGE | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| ASPIRATION | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| CHOKING | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| DYSPNEA | 7/374 (1.9%) | 7 | 4/376 (1.1%) | 4 |
| DYSPNEA EXERTIONAL | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| EXERTIONAL DYSPNOEA | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| HEMOPTYSIS | 1/374 (0.3%) | 1 | 1/376 (0.3%) | 1 |
| PAINFUL RESPIRATION | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| PHARYNGEAL INFLAMMATION | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| PNEUMOTHORAX | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| PULMONARY CONGESTION | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| PULMONARY EMBOLISM | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| PULMONARY OEDEMA | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| RESPIRATORY FAILURE | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| HYPERHIDROSIS | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| PSORIASIS | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| Surgical and medical procedures | ||||
| BRACHYTHERAPY TO UTERUS | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| CARDIAC ABLATION | 1/374 (0.3%) | 1 | 1/376 (0.3%) | 1 |
| CHOLECYSTECTOMY | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| HEMATOMA EVACUATION | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| HOSPITALISATION | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| HYSTEROSALPINGO-OOPHORECTOMY | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| RECTAL LESION EXCISION | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| THORACOTOMY | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| TONSILLECTOMY | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| VARICOSE VEIN OPERATION | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
| Vascular disorders | ||||
| AORTIC ANEURYSM | 1/374 (0.3%) | 1 | 1/376 (0.3%) | 1 |
| AORTIC DISSECTION | 1/374 (0.3%) | 2 | 0/376 (0%) | 0 |
| ARTERIOVENOUS FISTULA | 0/374 (0%) | 0 | 3/376 (0.8%) | 3 |
| ARTERITIS | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| CIRCULATORY COLLAPSE | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| HEMATOMA | 2/374 (0.5%) | 2 | 5/376 (1.3%) | 6 |
| HEMORRHAGE | 4/374 (1.1%) | 4 | 0/376 (0%) | 0 |
| HYPERTENSION | 2/374 (0.5%) | 3 | 2/376 (0.5%) | 2 |
| HYPERTENSIVE CRISIS | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| VARICOSE VEIN | 1/374 (0.3%) | 1 | 1/376 (0.3%) | 1 |
| VASCULITIS | 1/374 (0.3%) | 1 | 0/376 (0%) | 0 |
| VESSEL PERFORATION | 0/374 (0%) | 0 | 1/376 (0.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Cryoballoon Ablation | Radiofrequency Ablation | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/374 (0%) | 0/376 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Ralf Meyer |
|---|---|
| Organization | Medtronic |
| Phone | +49215981490 |
| ralf.meyer@medtronic.com |
Responsible Party:
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT01490814
Other Study ID Numbers:
- FI-123
First Posted:
Dec 13, 2011
Last Update Posted:
Nov 2, 2018
Last Verified:
Mar 1, 2018