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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical investigation conducted at 26 investigational sites in the United States and Canada. Subjects with paroxysmal atrial fibrillation (PAF) referred for ablative intervention after efficacy failure of one or more Study Atrial Fibrillation (AF) Drugs (flecainide, propafenone or sotalol) were randomized 2:1 to cryoablation intervention (Experimental Subjects, ES) or to a Study AF Drug (Control Subjects, CS). Subjects were followed for 12 months with scheduled and symptom-driven assessments to detect recurrent atrial fibrillation by means of periodic electrocardiograms, weekly scheduled trans-telephonic monitoring, patient-initiated trans-telephonic monitoring, and 24-hour Holter monitoring at 6 and 12 months. The first 90 days after study therapy was initiated was considered a blanked period for all subjects.
STOP AF (PS-023) is a randomized, controlled study of subjects 18 to 75 years old who had been referred for ablative intervention after failing one or two (but not all three) anti-arrhythmic drugs used in the treatment of AF (flecainide, propafenone and sotalol). Study subjects were randomized into two arms: the cryoablation (treatment) arm and the membrane-active antiarrhythmic drug (control) arm. A 90- day blanked follow-up period, including reablation and medication adjustments was applied in both arms to optimize therapies. All subjects underwent follow-up assessments at 1, 3, 6, 9 and 12 months, weekly transtelephonic monitoring, 24-hour Holter monitoring and CT/MRI of the pulmonary veins(at 6 and 12 months) during the trial period. Control subjects who were confirmed to be chronic treatment failures were permitted to crossover to cryoablation in this trial.
Acute procedural success was defined for subjects that underwent cryoablation and demonstrated electrical isolation in ≥ 3 Pulmonary Veins (PVs) at the conclusion of the first protocol-defined cryoablation procedure using the Arctic Front® Cardiac CryoAblation Catheter System.
The primary effectiveness endpoint was defined as having acute procedural success and freedom from chronic treatment failure (CTF) for experimental subjects, and freedom from CTF for control subjects. Freedom from (CTF) was defined for both groups as the occurrence of detectable AF during a non-blanked follow-up period, or an AF Intervention, or the use of a non-study AF drug at any time.
The co-primary safety outcome measures were Cryoablation Procedure Events (CPEs) in cryoablated subjects and Major Atrial Fibrillation Events (MAFEs) in both groups. CPEs were device- or procedure-related serious adverse events.
Other safety assessments were made during the course of the STOP AF trial specific to pulmonary vein stenosis (PVS) and phrenic nerve injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Experimental subjects received cryoablation intended to isolate the pulmonary veins and ablate arrhythmia foci. If necessary, experimental subjects were allowed a previously failed Study Atrial Fibrillation Drug (AF Drug). |
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| Control | Active Comparator | Control Subjects were treated with an AF Drug (flecainide, propafenone, or sotalol) that they had not previously failed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arctic Front® Cryoablation Catheter | Device | Experimental Subjects received cryoablation intended to isolate the pulmonary veins and ablate arrhythmia foci with the cryoablation catheter system. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Procedural Success (APS) | Acute Procedural Success was defined as a demonstration of electrical isolation in ≥ 3 Pulmonary Veins (PVs) at the conclusion of the first protocol-defined cryoablation procedure. APS was decided at the end of the procedure the mean time was calculated for the time frame. | 371.4 Minutes (Average) |
| Freedom From Chronic Treatment Failure (CTF) | Subjects that did not have or were free of CTF. CTF was defined as the occurence of an Atrial Fibrillation (AF) intervention, use of non-study AF drug therapy, or the occurence of detectable AF which is is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period. | 12 month follow up period |
| Treatment Success | Treatment Success was defined as Acute Procedure Success (APS) and freedom from Chronic Treatment Failure (CTF) for Experimental Subjects, and freedom from CTF for Control Subjects. Under this pre-specified definition of Treatment Success, Experimental Subjects must have had APS and remained free of CTF during the 12-month follow-up duration, while Control Subjects must have remained free of CTF during the 12-month follow-up duration. | 12 months |
| Freedom From Major Atrial Fibrillation Events (MAFEs) | Subjects that did not have or were free of MAFEs. MAFEs were serious adverse events categorized as cardiovascular death, myocardial infarction, stroke, or hospitalization for AF recurrence/ablation, flutter ablation, embolic events, heart failure, hemorrhage or anti-arrhythmic drug treatment. | 12 Months |
| Cryoablation Procedure Events (CPEs) | Subjects that had CPEs. CPEs were device- or procedure-related serious adverse events (SAE) categorized as access site complications, cardiac damage, pulmonary vein (PV) stenosis, embolic complications, arrhythmias, unresolved phrenic nerve palsy and death. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas L. Packer, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294-0007 | United States | ||
| Banner Good Samaritan Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23500312 | Derived | Packer DL, Kowal RC, Wheelan KR, Irwin JM, Champagne J, Guerra PG, Dubuc M, Reddy V, Nelson L, Holcomb RG, Lehmann JW, Ruskin JN; STOP AF Cryoablation Investigators. Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: first results of the North American Arctic Front (STOP AF) pivotal trial. J Am Coll Cardiol. 2013 Apr 23;61(16):1713-23. doi: 10.1016/j.jacc.2012.11.064. Epub 2013 Mar 21. |
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Investigators at 26 sites in the United States and Canada, enrolled and randomized a total of 245 study subjects, during the 21 months trial period, between 10 October 2006 and 30 June 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cryoablation | an experimental group receiving cryoablation and, optionally, a previously failed Atrial Fibrillation Drug.3 Subjects withdrew consent 5 subjects were a screen failure. Therefore N=163 for Experimental group. |
| FG001 | Standard Treatment With Drugs Only |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Flecainide or Sotalol or Propafenone | Drug | Flecainide 200 mg / day Propafenone 450 mg / day Propafenone-SR 650 mg / day Sotalol 240 mg / day |
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| To end of ablation procedure |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Cedar Sinai Medical Center | Los Angeles | California | 90048 | United States |
| UC Davis Medical Center | Sacramento | California | 98517 | United States |
| Stanford Hospital | Stanford | California | 94305-5233 | United States |
| Colorado Cardiac Alliance -- Memorial Hospital | Colorado Springs | Colorado | 80907 | United States |
| Mayo Clinic- Jacksonville | Jacksonville | Florida | 32224 | United States |
| BayHeart Group -- St-Joseph's Hospital | Tampa | Florida | 33607 | United States |
| Emery Crawford Long Hospital | Atlanta | Georgia | 30308 | United States |
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States |
| Iowa Heart Center | Des Moines | Iowa | 50314 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| New Mexico Heart Institute | Albuquerque | New Mexico | 87102 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania Health | Philadelphia | Pennsylvania | 19104-4283 | United States |
| Baylor Heart and Vascular Hospital | Dallas | Texas | 75226 | United States |
| Inova Research Center | Falls Church | Virginia | 22042 | United States |
| Sentara CV Research Institute | Norfolk | Virginia | 23507 | United States |
| Medical College of Virginia | Richmond | Virginia | 23219 | United States |
| Cardiology Associates of Green Bay | Green Bay | Wisconsin | 54301-3596 | United States |
| Arrhythmia Center of Southern WI | Milwaukee | Wisconsin | 53215 | United States |
| London Medical Health Sciences | London | Ontario | N6A5A5 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| Laval Hospital | Ste-Foy | Quebec | G1V 4G5 | Canada |
a control group receiving only an Atrial Fibrillation Drug. 4 Subject withdrew consent and 1 subject was a screen failure. Therefore- Control Treatment group N= 82. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cryoablation | an experimental group receiving cryoablation and, optionally, a previously failed Atrial Fibrillation Drug.3 Subjects withdrew consent 5 subjects were a screen failure. Therefore N=163 for Experimental group. |
| BG001 | Standard Treatment With Drugs Only | a control group receiving only an Atrial Fibrillation Drug. 4 Subject withdrew consent and 1 subject was a screen failure. Therefore- Control Treatment group N= 82. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Acute Procedural Success (APS) | Acute Procedural Success was defined as a demonstration of electrical isolation in ≥ 3 Pulmonary Veins (PVs) at the conclusion of the first protocol-defined cryoablation procedure. APS was decided at the end of the procedure the mean time was calculated for the time frame. | Subjects evaluated were from the modified Intent to Treat subset (mITT)or subjects that were enrolled, randomized and received treatment. | Posted | Number | participants | 371.4 Minutes (Average) |
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| Primary | Freedom From Chronic Treatment Failure (CTF) | Subjects that did not have or were free of CTF. CTF was defined as the occurence of an Atrial Fibrillation (AF) intervention, use of non-study AF drug therapy, or the occurence of detectable AF which is is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period. | This section includes data for subjects who were randomized, received treatment and were followed through 12-Months post randomized treatment regardless of AF Drug usage. Subjects who experienced Acute Procedural Failure in the Experimental group were not included in this analysis of post-procedural failure causes. | Posted | Number | participants | 12 month follow up period |
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| Primary | Treatment Success | Treatment Success was defined as Acute Procedure Success (APS) and freedom from Chronic Treatment Failure (CTF) for Experimental Subjects, and freedom from CTF for Control Subjects. Under this pre-specified definition of Treatment Success, Experimental Subjects must have had APS and remained free of CTF during the 12-month follow-up duration, while Control Subjects must have remained free of CTF during the 12-month follow-up duration. | The mITT population consisted of all subjects, who were enrolled, randomized and received treatment | Posted | Number | participants | 12 months |
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| Primary | Freedom From Major Atrial Fibrillation Events (MAFEs) | Subjects that did not have or were free of MAFEs. MAFEs were serious adverse events categorized as cardiovascular death, myocardial infarction, stroke, or hospitalization for AF recurrence/ablation, flutter ablation, embolic events, heart failure, hemorrhage or anti-arrhythmic drug treatment. | mITT set included all subjects (82 CS, 163 ES) who were enrolled, randomized, and received treatment. | Posted | Number | participants | 12 Months |
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| Primary | Cryoablation Procedure Events (CPEs) | Subjects that had CPEs. CPEs were device- or procedure-related serious adverse events (SAE) categorized as access site complications, cardiac damage, pulmonary vein (PV) stenosis, embolic complications, arrhythmias, unresolved phrenic nerve palsy and death. | Data for subjects who were randomized to the Experimental group and received cryoablation therapy were included in this analysis. All CPEs reported in the Experimental group were included in the analysis regardless of their association with the first or a repeat cryoablation. | Posted | Number | participants | To end of ablation procedure |
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All pharmacologic and ablative treatments and arrhythmic disease adverse events on study subjects were followed through 12 months of follow-up.
All serious adverse events (SAE) were adjudicated by the CEC to the protocol definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cryoablation | Experimental group or subjects that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter | 20 | 163 | 19 | 163 | ||
| EG001 | Standard Treatment With Drugs Only | A control group receiving only an Atrial Fibrillation Drug who have not previously failed a AF study drug. | 12 | 82 | 16 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| A fib persistent-drug load | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Abdominal wall hemorrhage | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Acute exacerbation of asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Acute pyelonephritis 2º to vesical catheter | Renal and urinary disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Acute renal failure requiring dialysis | Renal and urinary disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Altered mental status S/P cardiac arrest | Psychiatric disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Appendicitis | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Atrial flutter-recurrent | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Cardiac tamponade | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Cardiopulmonary arrest with resuscitation | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Cardiopulmonary decompensation-etiology uncertain | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Escherichia coli bacteremia | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
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| Focal hemorrhage of ileum 2º to warfarin induced coagulopathy | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Gastrointestinal bleeding | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Hematoma from left groin | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
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| Ileitis | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Increasing persistent A fib | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Interstitial pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Left atrial appendage thrombus | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Left popliteal deep vein thrombosis | Vascular disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Left upper + lower pulmonary vein stenosis | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Multiple organ failure | General disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Non Q wave myocardial infarction | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Non bacterial meningitis | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Occlusion left inferior pulmonary vein | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Pericardial effusion (tamponade) | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Persistent atrial fibrillation | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Physical deconditioning 2º to procedural complications and immobilization | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Pneumonia left lower lobe | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Pulmonary embolus | Vascular disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Rapid atrial flutter | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Recurrent atrial fibrillation | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Recurrent rapid A fibrillation | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Right diaphragm paresis | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Right lung blebs with persistent air leak | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Right wrist heparin lock insertion site infection | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
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| Sepsis induced hypotension | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
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| Subarachnoid hemorrhage | Vascular disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Subdural hematoma from fall | Vascular disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Wegener's granulomatosis | Blood and lymphatic system disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Worsened AF with rapid ventricular response | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Worsening AF | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment | Worsening Atrial Fibrillation |
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| Worsening atrial flutter | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Worsening atrial fib-flutter | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Atrial Flutter | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Chest Pain | General disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Chest Discomfort | General disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (8.1) | Non-systematic Assessment |
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| international Normalised Ratio Increased | Investigations | MedDRA (8.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Nelson, RN, BSN, MBA - AF Solutions Clinical Operations Director | Medtronic AF Solutions | (763)526-2891 | linda.k.nelson@medtronic.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005424 | Flecainide |
| D013015 | Sotalol |
| D011405 | Propafenone |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D011427 | Propiophenones |
| D007659 | Ketones |
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