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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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The purpose of this study is to determine whether catheter-based pulmonary vein isolation is superior to antiarrhythmic drugs as first line therapy in patients with symptomatic paroxysmal recurrent atrial fibrillation not previously treated with therapeutic doses of antiarrhythmic drugs.
Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice and is estimated to affect 2.2 million people in the United States. AF is a major cause of stroke, adversely affects quality of life, and is associated with increased mortality. Despite advances in antiarrhythmic drug therapy, AF continues to be associated with significant morbidity. Although antiarrhythmic drug therapy is currently considered a first-line option, recent data indicate that more than 35% of Patients will have recurrence of AF despite best antiarrhythmic drug (AAD) therapy, and more than 30% of Patients will discontinue the drugs because of adverse reactions. Furthermore, although recent trials have indicated equivalence of rhythm and rate control strategies in some patient populations, 25-35% of Patients with AF who are rate controlled will continue to have activity limiting symptoms. Newer measures to prevent, treat and potentially cure AF are needed. Seminal work by Haissaguerre and replicated by Chen showed that the majority of AF is initiated by ectopic foci found primarily in the pulmonary veins (PV). Experience with the catheter-based Maze technique led to observations that opened the door to effective and practical catheter-based cures for AF. In response to the difficulties of focal ablation, an alternate strategy has been developed that seeks to electrically isolate the Pulmonary Veins from the atrial tissue. Empirical PV isolation targets all of the PV's without regard to the initiation of ectopic beats. The goal is to create entrance block in the PV. Multipolar circular catheters and basket catheters have been developed that facilitate identification of the electrical connections that are present at the junction of the atrium and the PV, and radiofrequency energy is applied in a circumferential fashion until entrance block is achieved. Relative to focal ablation, circumferential PV isolation is simpler to perform, can be completed without inducing AF, has a shorter procedure time, and has a lower incidence of PV stenosis.
Comparison: Patients will have ablation to achieve entrance and/or exit block into all pulmonary veins, compared with patients receiving antiarrhythmic drugs given in accordance with ACC/AHA/ESC 2006 Guidelines for the Management of patients with AF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter Ablation | Experimental | Pulmonary vein isolation performed by catheter ablation for the prevention of recurrence of symptomatic atrial fibrillation |
|
| Antiarrhythmic Drug Therapy | Active Comparator | Conventional antiarrythmic drug therapy for the prevention of recurrence of symptomatic atrial fibrillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Vein Isolation performed by Catheter Ablation | Procedure | Ablation will be done to achieve entrance block into all pulmonary veins. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Recurrence of Atrial Tachyarrhythmia | Recurrence of electrocardiographically documented atrial fibrillation, atrial flutter or atrial tachycardia lasting >30 seconds during Follow-up Period. The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed). | Assessed during 21 month follow-up period |
| Comparison of Proportion of Patients With an Occurrence of Any of a Cluster of Serious Complications in Either Arm | Ablation arm cluster: death, cardiac tamponade, severe PV stenosis>70%, atrioesophageal fistula, thromboembolism, vascular complications (i.e. arterial pseudoaneurysm, arteriovenous fistula and hematoma leading to transfusion), phrenic nerve injury or complete AV block requiring permanent pacemaker implantation. Antiarrhythmic drug arm cluster: Death, torsade de pointes, bradycardia leading to pacemaker insertion, syncope, QRS duration prolongation > 50% of baseline, 1:1 atrial flutter or any other significant adverse events that leads to drug discontinuation. | Assessed during entire 24 month study period |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Recurrence of Symptomatic Atrial Tachyarrhythmia | Including only symptomatic episodes of all atrial tachyarrhythmias (atrial fibrillation, atrial flutter and atrial tachycardia). The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed). | 21 months of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos A Morillo, MD | Population Health Research Institute, Hamilton Health Sciences Corporation and McMaster University | Principal Investigator |
| Natale Andrea, MD | Texas Cardiac Arrhythmia Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Cardiac Arrhythmia Foundation | Austin | Texas | 78705 | United States | ||
| Austin Heart |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9737513 | Background | Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946. | |
| 16904574 | Background | European Heart Rhythm Association; Heart Rhythm Society; Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Zamorano JL; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; European Society of Cardiology Committee for Practice Guidelines; Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation). J Am Coll Cardiol. 2006 Aug 15;48(4):854-906. doi: 10.1016/j.jacc.2006.07.009. No abstract available. |
| Label | URL |
|---|---|
| Population Health Research Institute - The RAAFT Study - Sponsor and Central Coordination | View source |
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Eligible consenting patients from 16 sites in Canada and Europe were randomly assigned 1:1 to the Catheter Ablation arm or Antiarrythmic Drug Therapy arm. The randomization schedule was computer generated and stratified by site with variable block size.
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| ID | Title | Description |
|---|---|---|
| FG000 | Catheter Ablation | Pulmonary vein isolation performed by catheter ablation for the prevention of recurrence of symptomatic atrial fibrillation |
| FG001 | Antiarrhythmic Drug Therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Conventional Antiarrhythmic Drug Therapy | Drug | Anti-Arrhythmic Drugs per ACC/AHA 2006 Guidelines for the Management of Patients with AF |
|
| Number of Participants With Recurrence of Symptomatic Atrial Fibrillation | Including only symptomatic episodes of atrial fibrillation in the outcome measure (excluding asymptomatic events and events adjudicated as atrial flutter or atrial tachycardia). The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed). | During 21 month follow-up period |
| Episodes of ANY Recurrence of Atrial Tachyarrhythmia | Including all episodes of symptomatic or asymptomatic atrial fibrillation, atrial flutter and atrial tachycardia. The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed). | During 21 month follow-up period |
| Number of Participants With Recurrence of Atrial Tachyarrhythmia Obtained Clinically | Including only events documented by 12 lead ECG, Holter monitoring or rhythm strips but excluding TTM monitoring. The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed). | During 21 month follow-up period |
| Quality of Life EQ5D Index Score | The standard EQ-5D questionnaire is completed by study participants. The EQ-5D Index score is a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Self-reported severity for each dimension is given on a 3 level scale: (1) no problems, (2) some problems or (3) major problems. For example a health state: 11223 means: no problems with mobility (1), no problems with self-care (1), some problems with performing usual activity (2), moderate pain/discomfort (2), and major anxiety/depression (3). Thus there are 243 patterns of health state: 11111 to 33333. Scores are converted to a single weighted index score (utility). The index score is derived by applying a formula as developed by Shaw JW, Johnson JA, Coons SJ. US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med Care 2005; 43(3): 203-220. The final score has a minimum value of 0 and maximum value of 1 (no problems). | Measured at 12 months after randomization |
| Quality of Life EQ-5D Visual Analog Score | The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. The scale measures how good/bad one's own health is today, in one's own opinion. 0 means the worst imaginable state of health; 100 means the best imaginable state of health. | Measured At 12 months after randomization |
| Austin |
| Texas |
| 78756 |
| United States |
| Victoria Cardiac Arrhythmia Trials Inc. | Victoria | British Columbia | V8R 4R2 | Canada |
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
| London Health Sciences Centre University Hospital | London | Ontario | N6A 5A5 | Canada |
| Southlake Regional Health Centre | Newmarket | Ontario | L3Y 2P9 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| McGill University | Montreal | Quebec | H3G 1A4 | Canada |
| Institut Universitaire de Cardiologie et Pneumologie de Québec | Québec | G1V 4G5 | Canada |
| Institute for Clinical and Experimental Medicine | Prague | Prague 4 | Czechia |
| Charles University | Prague | Czechia |
| Abteilung Rhythmologie | Bad Krozingen | 79188 | Germany |
| Asklepios Klinik St. Georg | Hamburg | 79188 | Germany |
| University Hospital Eppendorf | Hamburg | D-20246 | Germany |
| F. Miulli Hospital | Acquaviva delle Fonti | Bari | 70021 | Italy |
| 8985802 | Background | Haissaguerre M, Jais P, Shah DC, Gencel L, Pradeau V, Garrigues S, Chouairi S, Hocini M, Le Metayer P, Roudaut R, Clementy J. Right and left atrial radiofrequency catheter therapy of paroxysmal atrial fibrillation. J Cardiovasc Electrophysiol. 1996 Dec;7(12):1132-44. doi: 10.1111/j.1540-8167.1996.tb00492.x. |
| 9725923 | Background | Haissaguerre M, Jais P, Shah DC, Takahashi A, Hocini M, Quiniou G, Garrigue S, Le Mouroux A, Le Metayer P, Clementy J. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998 Sep 3;339(10):659-66. doi: 10.1056/NEJM199809033391003. |
| 10709719 | Background | Chen SA, Tai CT, Tsai CF, Hsieh MH, Ding YA, Chang MS. Radiofrequency catheter ablation of atrial fibrillation initiated by pulmonary vein ectopic beats. J Cardiovasc Electrophysiol. 2000 Feb;11(2):218-27. doi: 10.1111/j.1540-8167.2000.tb00324.x. |
| 10736285 | Background | Haissaguerre M, Jais P, Shah DC, Garrigue S, Takahashi A, Lavergne T, Hocini M, Peng JT, Roudaut R, Clementy J. Electrophysiological end point for catheter ablation of atrial fibrillation initiated from multiple pulmonary venous foci. Circulation. 2000 Mar 28;101(12):1409-17. doi: 10.1161/01.cir.101.12.1409. |
| 12142112 | Background | Marrouche NF, Dresing T, Cole C, Bash D, Saad E, Balaban K, Pavia SV, Schweikert R, Saliba W, Abdul-Karim A, Pisano E, Fanelli R, Tchou P, Natale A. Circular mapping and ablation of the pulmonary vein for treatment of atrial fibrillation: impact of different catheter technologies. J Am Coll Cardiol. 2002 Aug 7;40(3):464-74. doi: 10.1016/s0735-1097(02)01972-1. |
| 12173906 | Background | Ng FS, Camm AJ. Catheter ablation of atrial fibrillation. Clin Cardiol. 2002 Aug;25(8):384-94. doi: 10.1002/clc.4950250808. |
| 16253904 | Background | Oral H, Chugh A, Good E, Igic P, Elmouchi D, Tschopp DR, Reich SS, Bogun F, Pelosi F Jr, Morady F. Randomized comparison of encircling and nonencircling left atrial ablation for chronic atrial fibrillation. Heart Rhythm. 2005 Nov;2(11):1165-72. doi: 10.1016/j.hrthm.2005.08.003. |
| 15928285 | Background | Wazni OM, Marrouche NF, Martin DO, Verma A, Bhargava M, Saliba W, Bash D, Schweikert R, Brachmann J, Gunther J, Gutleben K, Pisano E, Potenza D, Fanelli R, Raviele A, Themistoclakis S, Rossillo A, Bonso A, Natale A. Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of symptomatic atrial fibrillation: a randomized trial. JAMA. 2005 Jun 1;293(21):2634-40. doi: 10.1001/jama.293.21.2634. |
| 15936622 | Background | Scherlag BJ, Yamanashi W, Patel U, Lazzara R, Jackman WM. Autonomically induced conversion of pulmonary vein focal firing into atrial fibrillation. J Am Coll Cardiol. 2005 Jun 7;45(11):1878-86. doi: 10.1016/j.jacc.2005.01.057. |
| 15172410 | Background | Nademanee K, McKenzie J, Kosar E, Schwab M, Sunsaneewitayakul B, Vasavakul T, Khunnawat C, Ngarmukos T. A new approach for catheter ablation of atrial fibrillation: mapping of the electrophysiologic substrate. J Am Coll Cardiol. 2004 Jun 2;43(11):2044-53. doi: 10.1016/j.jacc.2003.12.054. |
| 24549549 | Derived | Morillo CA, Verma A, Connolly SJ, Kuck KH, Nair GM, Champagne J, Sterns LD, Beresh H, Healey JS, Natale A; RAAFT-2 Investigators. Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of paroxysmal atrial fibrillation (RAAFT-2): a randomized trial. JAMA. 2014 Feb 19;311(7):692-700. doi: 10.1001/jama.2014.467. |
Conventional antiarrythmic drug therapy for the prevention of recurrence of symptomatic atrial fibrillation
| Received Allocated Intervention |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Catheter Ablation | Pulmonary vein isolation performed by catheter ablation for the prevention of recurrence of symptomatic atrial fibrillation |
| BG001 | Antiarrhythmic Drug Therapy | Conventional antiarrythmic drug therapy for the prevention of recurrence of symptomatic atrial fibrillation |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| 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 Participants With Recurrence of Atrial Tachyarrhythmia | Recurrence of electrocardiographically documented atrial fibrillation, atrial flutter or atrial tachycardia lasting >30 seconds during Follow-up Period. The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed). | All randomized patients | Posted | Count of Participants | Participants | Assessed during 21 month follow-up period |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Comparison of Proportion of Patients With an Occurrence of Any of a Cluster of Serious Complications in Either Arm | Ablation arm cluster: death, cardiac tamponade, severe PV stenosis>70%, atrioesophageal fistula, thromboembolism, vascular complications (i.e. arterial pseudoaneurysm, arteriovenous fistula and hematoma leading to transfusion), phrenic nerve injury or complete AV block requiring permanent pacemaker implantation. Antiarrhythmic drug arm cluster: Death, torsade de pointes, bradycardia leading to pacemaker insertion, syncope, QRS duration prolongation > 50% of baseline, 1:1 atrial flutter or any other significant adverse events that leads to drug discontinuation. | All patients treated | Posted | Count of Participants | Participants | Assessed during entire 24 month study period |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Recurrence of Symptomatic Atrial Tachyarrhythmia | Including only symptomatic episodes of all atrial tachyarrhythmias (atrial fibrillation, atrial flutter and atrial tachycardia). The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed). | All patients randomized | Posted | Number | participants | 21 months of follow-up |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Recurrence of Symptomatic Atrial Fibrillation | Including only symptomatic episodes of atrial fibrillation in the outcome measure (excluding asymptomatic events and events adjudicated as atrial flutter or atrial tachycardia). The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed). | All patients randomized | Posted | Number | participants | During 21 month follow-up period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Episodes of ANY Recurrence of Atrial Tachyarrhythmia | Including all episodes of symptomatic or asymptomatic atrial fibrillation, atrial flutter and atrial tachycardia. The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed). | All patients randomized | Posted | Number | Episodes | During 21 month follow-up period | Number of ECGs Adjudicated | Number of ECGs Adjudicated |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Recurrence of Atrial Tachyarrhythmia Obtained Clinically | Including only events documented by 12 lead ECG, Holter monitoring or rhythm strips but excluding TTM monitoring. The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed). | All patients randomized | Posted | Number | participants | During 21 month follow-up period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life EQ5D Index Score | The standard EQ-5D questionnaire is completed by study participants. The EQ-5D Index score is a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Self-reported severity for each dimension is given on a 3 level scale: (1) no problems, (2) some problems or (3) major problems. For example a health state: 11223 means: no problems with mobility (1), no problems with self-care (1), some problems with performing usual activity (2), moderate pain/discomfort (2), and major anxiety/depression (3). Thus there are 243 patterns of health state: 11111 to 33333. Scores are converted to a single weighted index score (utility). The index score is derived by applying a formula as developed by Shaw JW, Johnson JA, Coons SJ. US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med Care 2005; 43(3): 203-220. The final score has a minimum value of 0 and maximum value of 1 (no problems). | EQ-5D completed at 12 months | Posted | Median | Inter-Quartile Range | Index score | Measured at 12 months after randomization |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life EQ-5D Visual Analog Score | The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. The scale measures how good/bad one's own health is today, in one's own opinion. 0 means the worst imaginable state of health; 100 means the best imaginable state of health. | Participants with EQ5D VAS completed at 12 months after randomization. | Posted | Median | Inter-Quartile Range | score on a scale | Measured At 12 months after randomization |
|
|
Duration of follow-up from randomization until completion of follow-up, up to 24 months after randomization. Assessments occurred at 1, 3, 4, 6, 9, 12, 18 and 24 months.
All SAEs (standard definitions) were reported to the central coordinating center within 24 hours of knowledge of the event. A plan was in place for expedited notification to the FDA of any unanticipated fatal or life-threatening adverse events related to either intervention. No such events occurred during study follow-up.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Catheter Ablation | First-line treatment with radiofrequency catheter ablation procedure | 0 | 65 | 6 | 65 | 21 | 65 |
| EG001 | Antiarrhythmic Drug Therapy | Standard antiarrhythmic drug therapy | 0 | 60 | 2 | 60 | 19 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Post procedural infection | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Subdural hematoma | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pulmonary tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| joint injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Congenital bladder anomaly | Congenital, familial and genetic disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Sensation of foreign body | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hepatic fibrosis | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Localized infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| urinary tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Prostate infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Nerve injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Aspartate aminotransferase incrased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Biopsy liver | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Angiogram normal | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carlos A. Morillo, MD, FRCPC, FACC, FHRS, FESC, FHRS | Population Health Research Institute | 905-527-4322 | 40311 | Carlos.Morillo@phri.ca |
| 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 |
Not provided
Not provided
| >=65 years |
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| Male |
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| Czech Republic |
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| Canada |
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| Germany |
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| Italy |
|
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| Number of ECGs Adjudicated |
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