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This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiCathâ„¢ Contact Force Ablation Catheter, Sensor Enabledâ„¢ (TactiCath SE) for use in cardiac electrophysiological mapping and for the treatment of drug-refractory, recurrent symptomatic persistent atrial fibrillation (AF) when used in conjunction with a compatible radiofrequency (RF) generator and three-dimensional mapping system. This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the TactiCath SE ablation catheter for the treatment of drug refractory, symptomatic persistent atrial fibrillation in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablation | Experimental | Enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment TactiCathâ„¢ Contact Force Ablation Catheter, Sensor Enabledâ„¢ (TactiCath SE). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TactiCathâ„¢ Contact Force Ablation Catheter, Sensor Enabledâ„¢ | Device | Ablation procedure for Persistent AF |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Subjects With a Device and/or Procedure-related SAE. | Rate of subjects with a device and/or procedure-related SAE with onset within 7-days of any ablation procedure that used the investigational device. | Within 7 days of initial or repeat procedure performed ≤180 days of initial procedure |
| Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence. | The following events were considered a failure for AF/AFL/AT recurrence:
| 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Procedural Success | Percent of subjects who achieve acute procedural success defined as confirmation of entrance block in all pulmonary veins | Immediate post procedure |
| 15-month Success Off of Antiarrhythmic Drugs |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital (UAB) | Birmingham | Alabama | 35249 | United States | ||
| St. Bernards |
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One subject was withdrawn after meeting enrollment criteria but prior to procedure with the investigational device.
A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled | A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 14, 2019 | Jan 18, 2022 |
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Percent of subjects off all AADs taken to treat AF/AFL/AT who achieve15-month success, defined as freedom from documented AF/AFL/AT recurrence (episodes >30 seconds) during the 9-month period following the blanking and therapy consolidation periods.
| 15 months |
| 15 Month Single Procedure Success | Percent of subjects who achieve 15-month single procedure success, defined as freedom from documented AF/AFL/AT recurrence (episodes >30 seconds) during the 9-month period following the blanking and therapy consolidation periods after a single ablation procedure. Any repeat ablation procedure required by the subject at any time was deemed an effectiveness failure in this analysis. | 15 months |
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| Arkansas Heart Hosptial | Little Rock | Arkansas | 72211 | United States |
| Scripps Health | La Jolla | California | 92037 | United States |
| Sequoia Hospital | Redwood City | California | 94062 | United States |
| South Denver Cardiology Associates | Littleton | Colorado | 80120 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Emory University Hosptial | Atlanta | Georgia | 30322 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Johns Hopkins University Hospital | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Bryan Heart | Lincoln | Nebraska | 68506 | United States |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | United States |
| New York University Hospital | New York | New York | 10016 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Texas Cardiac Arrhythmia | Austin | Texas | 78705 | United States |
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | United States |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Royal Melbourne Hospital - City Campus | Parkville | Victoria | 3050 | Australia |
| Ablation Procedure |
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| Pre-Discharge |
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| 7-day Follow-Up |
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| 3-month Follow-Up |
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| 6-month Follow-up |
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| 12-month Follow-Up |
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| 15-month Follow-Up |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ablation | All enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | 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 | Rate of Subjects With a Device and/or Procedure-related SAE. | Rate of subjects with a device and/or procedure-related SAE with onset within 7-days of any ablation procedure that used the investigational device. | The analysis population for the primary safety endpoint is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment and who have completed their 7-day follow-up visit; or crossed the end of the 7-day visit window without the visit but with a primary safety endpoint event | Posted | Count of Participants | Participants | Within 7 days of initial or repeat procedure performed ≤180 days of initial procedure |
|
|
| ||||||||||||||||||||||||||
| Primary | Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence. | The following events were considered a failure for AF/AFL/AT recurrence:
| The analysis population for the primary effectiveness endpoint is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment and who have completed their 15-month ECG, TTM, and/or 24-hour Holter assessment; or crossed the end of the 15-month visit window without the ECG, TTM and/or 24-hour Holter assessment but with a prior primary effectiveness endpoint event. | Posted | Count of Participants | Participants | 15 months |
| ||||||||||||||||||||||||||||
| Secondary | Acute Procedural Success | Percent of subjects who achieve acute procedural success defined as confirmation of entrance block in all pulmonary veins | The analysis population is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment | Posted | Count of Participants | Participants | Immediate post procedure |
|
| |||||||||||||||||||||||||||
| Secondary | 15-month Success Off of Antiarrhythmic Drugs | Percent of subjects off all AADs taken to treat AF/AFL/AT who achieve15-month success, defined as freedom from documented AF/AFL/AT recurrence (episodes >30 seconds) during the 9-month period following the blanking and therapy consolidation periods. | The analysis population is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment and who have completed their 15-month ECG, TTM, and/or 24-hour Holter assessment; or crossed the end of the 15-month visit window without the ECG, TTM and/or 24-hour Holter assessment but with a prior primary effectiveness endpoint event. | Posted | Count of Participants | Participants | 15 months |
|
| |||||||||||||||||||||||||||
| Secondary | 15 Month Single Procedure Success | Percent of subjects who achieve 15-month single procedure success, defined as freedom from documented AF/AFL/AT recurrence (episodes >30 seconds) during the 9-month period following the blanking and therapy consolidation periods after a single ablation procedure. Any repeat ablation procedure required by the subject at any time was deemed an effectiveness failure in this analysis. | The analysis population is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment and who have completed their 15-month ECG, TTM, and/or 24-hour Holter assessment; or crossed the end of the 15-month visit window without the ECG, TTM and/or 24-hour Holter assessment but with a prior primary effectiveness endpoint event. | Posted | Count of Participants | Participants | 15 months |
|
|
15 months
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
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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 | Enrolled | A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria | 2 | 224 | 59 | 224 | 29 | 224 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Non-systematic Assessment |
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| Bleeding/Anemia | Vascular disorders | Non-systematic Assessment |
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| Cerebrovascular Accident/Stroke | Nervous system disorders | Non-systematic Assessment |
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| Coronary Artery Thrombosis/Occlusion | Cardiac disorders | Non-systematic Assessment |
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| Elective Procedure/Surgery | General disorders | Non-systematic Assessment |
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| Heart Failure/Pump Failure | Cardiac disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Infection | Infections and infestations | Non-systematic Assessment |
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| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Renal Decompensation/Acute Kidney Injury | Renal and urinary disorders | Non-systematic Assessment |
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| Respiratory Compromise/Decompensation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Shock | Vascular disorders | Non-systematic Assessment |
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| Syncope/Dizziness | General disorders | Non-systematic Assessment |
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| Valve Insufficiency | Cardiac disorders | Non-systematic Assessment |
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| Volume Overload | Vascular disorders | Non-systematic Assessment |
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| Acute Ischemic Colitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Bowel Obstruction | Gastrointestinal disorders | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | Non-systematic Assessment |
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| Cholecystitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Collapse | General disorders | Non-systematic Assessment |
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| Colon Obstruction | Gastrointestinal disorders | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Fracture of Humerous | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Lower GI Bleed | Gastrointestinal disorders | Non-systematic Assessment |
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| Pelvic Inflammatory Disease | Infections and infestations | Non-systematic Assessment |
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| Penile Fracture | Reproductive system and breast disorders | Non-systematic Assessment |
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| Rectal and Vaginal Prolapse Repair | General disorders | Non-systematic Assessment |
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| Right Hip Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Sick Sinus Symptom | Cardiac disorders | Non-systematic Assessment |
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| Sinus Bradycardia | Cardiac disorders | Non-systematic Assessment |
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| Sudden Cardiac Death | General disorders | Non-systematic Assessment |
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| Trauma | General disorders | Non-systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | Non-systematic Assessment |
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| Urosepsis | Infections and infestations | Non-systematic Assessment |
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| Allergic Reaction | Immune system disorders | Non-systematic Assessment |
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| Chest Pain/Discomfort | Cardiac disorders | Non-systematic Assessment |
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| Cardiac Perforation or Tamponade | Cardiac disorders | Non-systematic Assessment |
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| Gastroparesis | Gastrointestinal disorders | Non-systematic Assessment |
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| Pericardial Effusion | Cardiac disorders | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | Non-systematic Assessment |
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| Encephalopathy | Psychiatric disorders | Non-systematic Assessment |
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| Jaw and Neck Pain | General disorders | Non-systematic Assessment |
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| Tracheobronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Hypotension | Vascular disorders | Non-systematic Assessment |
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| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Air Embolism | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Arrhythmia | Cardiac disorders | Non-systematic Assessment |
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| Chest Pain/Discomfort | Cardiac disorders | Non-systematic Assessment |
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| Infection | Infections and infestations | Non-systematic Assessment |
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| Pericardial Effusion | Cardiac disorders | Non-systematic Assessment |
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| Pericarditis | Cardiac disorders | Non-systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Thrombosis/Thrombus | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Transient Ischemic Attack | General disorders | Non-systematic Assessment |
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| Vascular Access Complication | Vascular disorders | Non-systematic Assessment |
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| Vascular Bleeding/Local Hematoma/Ecchymosis | Vascular disorders | Non-systematic Assessment |
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| Volume Overload | Vascular disorders | Non-systematic Assessment |
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| Congestive Heart Failure | Cardiac disorders | Non-systematic Assessment |
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| Cough | General disorders | Non-systematic Assessment |
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| Elevated Troponin | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Esophageal Inflammation | Gastrointestinal disorders | Non-systematic Assessment |
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| Fluid Retention | General disorders | Non-systematic Assessment |
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| Headache | General disorders | Non-systematic Assessment |
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| Hepatohepatomegaly With Elevated Liver Enzymes | Hepatobiliary disorders | Non-systematic Assessment |
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| Jaw Pain | General disorders | Non-systematic Assessment |
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| Shoulder Blade/ Arm Pit Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Trochanteric Bursitis | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amber Miller | Abbott Medical | (612) 413-7236 | amber.miller@abbott.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 27, 2020 | Feb 10, 2022 | SAP_002.pdf |
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| 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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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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