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The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheters with Contact Force Sensing Capability in the treatment of drug refractory symptomatic paroxysmal Atrial Fibrillation (AF) during standard electrophysiology mapping and RF procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THERMOCOOL® SMARTTOUCH™ Catheter | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THERMOCOOL® SMARTTOUCH™ Catheter | Device | AF Ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up | The primary effectiveness endpoint for this study will be freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up (includes a three month blanking period). | 12-months |
| Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events. | Primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient Ischemic Attack (TIA), Stroke / Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac Tamponade, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular Access Complications, Pulmonary edema, Hospitalization (initial and prolonged), and Heart block. | 7 days of the AF ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Acute Success | Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV). | End of procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Natale, MD | Texas Cardiac Arrhythmia Research | Study Chair |
| David J Wilber, MD | Loyola University | Study Chair |
| Francis E Marchlinski, MD | University of Pennsylvania | Study Chair |
| Douglas L Packer, MD | Mayo Clinic | Study Chair |
| Hiroshi Nakagawa, MD, Ph.D. | University of Oklahoma | Study Chair |
| Hans Kottkamp, MD | University Leipzig | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29759747 | Derived | Reddy VY, Pollak S, Lindsay BD, McElderry HT, Natale A, Kantipudi C, Mansour M, Melby DP, Lakkireddy D, Levy T, Izraeli D, Sangli C, Wilber D. Relationship Between Catheter Stability and 12-Month Success After Pulmonary Vein Isolation: A Subanalysis of the SMART-AF Trial. JACC Clin Electrophysiol. 2016 Nov;2(6):691-699. doi: 10.1016/j.jacep.2016.07.014. Epub 2016 Nov 21. | |
| 25125294 |
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The first subject was enrolled on June 02, 2011. Twenty-one (21) sites enrolled subjects. Last patient enrolled on December 22, 2011. Last procedure on December 29, 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | THERMOCOOL® SMARTTOUCH™ Catheter | THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled subjects, including all who signed inform consent form.
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| ID | Title | Description |
|---|---|---|
| BG000 | THERMOCOOL® SMARTTOUCH™ Catheter | THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up | The primary effectiveness endpoint for this study will be freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up (includes a three month blanking period). | Primary Effectiveness Cohort includes those enrolled who met the inclusion/exclusion criteria and had undergone insertion of the study catheter and Atrial Fibrillation (AF) ablation procedure, excluding those with radiofrequency energy not delivered, with calibration roll-in, and with only non-study arrhythmia. | Posted | Number | 95% Confidence Interval | percentage of participants | 12-months |
|
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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 | THERMOCOOL® SMARTTOUCH™ Catheter | THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIAL FLUTTER | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANEMIA | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Stagg, Manager, Clinical Operations | Biosense Webster, Inc. | (800) 729-9010 | 8611 | RStagg@its.jnj.com |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D001145 | Arrhythmias, Cardiac |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Derived |
| Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, Kantipudi C, Mansour MC, Melby DP, Packer DL, Nakagawa H, Zhang B, Stagg RB, Boo LM, Marchlinski FE. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014 Aug 19;64(7):647-56. doi: 10.1016/j.jacc.2014.04.072. |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events. | Primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient Ischemic Attack (TIA), Stroke / Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac Tamponade, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular Access Complications, Pulmonary edema, Hospitalization (initial and prolonged), and Heart block. | Safety cohort includes all enrolled subjects who had the study catheter inserted. | Posted | Number | 95% Confidence Interval | Percentage of patients with primary AE | 7 days of the AF ablation procedure |
|
|
|
| Secondary | Rate of Acute Success | Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV). | The analysis population for this endpoint includes two groups; a): Calibration Roll-in subjects who were prospectively identified prior to the study procedure and b) the Effectiveness Cohort. Both groups underwent an AF ablation procedure with the study catheter. | Posted | Number | percentage of participants | End of procedure |
|
|
|
| 38 |
| 161 |
| 70 |
| 161 |
| CARDIAC TAMPONADE | Cardiac disorders | Systematic Assessment |
|
| HEART BLOCK | Cardiac disorders | Systematic Assessment |
|
| HOSPITALIZATION, INTIAL AND PROLONGED | Cardiac disorders | Systematic Assessment |
|
| PAF ABLATION REDO | Cardiac disorders | Systematic Assessment |
|
| PERICARDITIS | Cardiac disorders | Systematic Assessment |
|
| VASOVAGAL SYNCOPE BECAUSE OF LEG CRAMPS | Cardiac disorders | Systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | Systematic Assessment |
|
| HOSPITALIZATION, INTIAL AND PROLONGED | Gastrointestinal disorders | Systematic Assessment |
|
| FEVER | General disorders | Systematic Assessment |
|
| HOSPITALIZATION, INTIAL AND PROLONGED | Infections and infestations | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | Systematic Assessment |
|
| VIRAL INFECTION RESULTING IN HOSPITALIZATION, PHLEBITIS FROM IV | Infections and infestations | Systematic Assessment |
|
| WBC ELEVATED, ABDOMINAL PAIN, ILEUS AND LOSS OF CAPTURE IN RV LEAD POST-LASER LEAD EXTRACT | Infections and infestations | Systematic Assessment |
|
| CHEST PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| HOSPITALIZATION, INTIAL AND PROLONGED | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| LEFT KNEE INJURY | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| LEFT ARM PAIN | Nervous system disorders | Systematic Assessment |
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| LOC | Nervous system disorders | Systematic Assessment |
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| MIGRAINES | Nervous system disorders | Systematic Assessment |
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| HOSPITALIZATION, INTIAL AND PROLONGED | Renal and urinary disorders | Systematic Assessment |
|
| HOSPITALIZATION, INTIAL AND PROLONGED | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| LUNG MASS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| HOSPITALIZATION, INTIAL AND PROLONGED | Vascular disorders | Systematic Assessment |
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| VASCULAR ACCESS COMPLICATIONS | Vascular disorders | Systematic Assessment |
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| AF | Cardiac disorders | Systematic Assessment |
|
| AFLUTTER | Cardiac disorders | Systematic Assessment |
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| AORTIC ROOT DILATION | Cardiac disorders | Systematic Assessment |
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| ARRHYTHMIA -FLUTTER | Cardiac disorders | Systematic Assessment |
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| ARRYTHMIA | Cardiac disorders | Systematic Assessment |
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| ATRIAL FIBRILLATION | Cardiac disorders | Systematic Assessment |
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| ATRIAL FIBRILLATION RECURRENCE | Cardiac disorders | Systematic Assessment |
|
| ATRIAL FIBRILLATION, FLUTTER | Cardiac disorders | Systematic Assessment |
|
| ATRIAL FLUTTER | Cardiac disorders | Systematic Assessment |
|
| ATRIAL TACHYCARDIA | Cardiac disorders | Systematic Assessment |
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| BILATERAL LOWER EXTREMITY EDEMA AND PAIN | Cardiac disorders | Systematic Assessment |
|
| BREAKTHROUGH A-FIB | Cardiac disorders | Systematic Assessment |
|
| CARDIOVERSION FOR ATRIAL TACH | Cardiac disorders | Systematic Assessment |
|
| CHEST DISCOMFORT | Cardiac disorders | Systematic Assessment |
|
| EXERTIONAL ANGINA | Cardiac disorders | Systematic Assessment |
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| HEART RACING, LIGHTHEADED, CHEST PAIN | Cardiac disorders | Systematic Assessment |
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| HOSPITALIZATION, INTIAL AND PROLONGED | Cardiac disorders | Systematic Assessment |
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| HYPOTENSION | Cardiac disorders | Systematic Assessment |
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| NEAR-SYNCOPAL EPISODES | Cardiac disorders | Systematic Assessment |
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| NEW DIAGNOSIS OF ATYPICAL ATRIAL FLUTTER | Cardiac disorders | Systematic Assessment |
|
| PERICARDIAL EFFUSION | Cardiac disorders | Systematic Assessment |
|
| PERICARDITIS | Cardiac disorders | Systematic Assessment |
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| PERICARDIUM STAIN | Cardiac disorders | Systematic Assessment |
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| RAPID ATRIAL FIB | Cardiac disorders | Systematic Assessment |
|
| RAPID ATRIAL FLUTTER | Cardiac disorders | Systematic Assessment |
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| RECURRENCE AFIB REQUIRING CVS | Cardiac disorders | Systematic Assessment |
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| RECURRENCE OF AF REQUIRING CARDIOVERSION | Cardiac disorders | Systematic Assessment |
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| RECURRENCE OF AFIB REQUIRING REPEAT ABLATION | Cardiac disorders | Systematic Assessment |
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| RECURRENT AF REQUIRING CARDIOVERSION | Cardiac disorders | Systematic Assessment |
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| REPEAT PULMONARY VEIN ISOLATION | Cardiac disorders | Systematic Assessment |
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| RIGHT SIDED ATRIAL FLUTTER | Cardiac disorders | Systematic Assessment |
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| STRONG HEART BEAT | Cardiac disorders | Systematic Assessment |
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| VASOVAGAL EVENT | Cardiac disorders | Systematic Assessment |
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| VOLUME OVERLOAD | Cardiac disorders | Systematic Assessment |
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| ADRENAL GLAND MASS | Endocrine disorders | Systematic Assessment |
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| BLURRED VISION | Eye disorders | Systematic Assessment |
|
| BLURRY VISION, TINNITUS, HEADACHE | Eye disorders | Systematic Assessment |
|
| CHEST PAIN | Gastrointestinal disorders | Systematic Assessment |
|
| DIAHRRHEA / STOMACH VIRUS | Gastrointestinal disorders | Systematic Assessment |
|
| DIARRHEA , GAS | Gastrointestinal disorders | Systematic Assessment |
|
| GERD, TROUBLE SWALLOWING | Gastrointestinal disorders | Systematic Assessment |
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| HOSPITALIZATION, INTIAL AND PROLONGED | Gastrointestinal disorders | Systematic Assessment |
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| INTERMITTENT GASTRIC BURNING | Gastrointestinal disorders | Systematic Assessment |
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| NEW ONSET DIABETES | Gastrointestinal disorders | Systematic Assessment |
|
| STOMACH VIRUS | Gastrointestinal disorders | Systematic Assessment |
|
| FEVER | General disorders | Systematic Assessment |
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| INCREASED TEMPERATURE | General disorders | Systematic Assessment |
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| WASHED OUT FEELING | General disorders | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | Systematic Assessment |
|
| HOSPITALIZATION, INTIAL AND PROLONGED | Infections and infestations | Systematic Assessment |
|
| SINUS INFECTION | Infections and infestations | Systematic Assessment |
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| SINUSITIS/BRONCHITIS | Infections and infestations | Systematic Assessment |
|
| UPPER RESPIRATORY INFECTION | Infections and infestations | Systematic Assessment |
|
| VIRAL INFECTION | Infections and infestations | Systematic Assessment |
|
| FALL - DUE TO SLIP | Injury, poisoning and procedural complications | Systematic Assessment |
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| ADHESIVE CAPSULITIS OF SHOULDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| BRONCHITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| CHEST PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| EAR INFECTION | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| HOSPITALIZATION, INTIAL AND PROLONGED | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| LEFT SHOULDER/ARM PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| PARTIAL KNEE REPLACEMENT | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| PINCHED NERVES | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| PLANTER FASCIITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| REPAIR OF BICEP TENDON | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| SYNOVIAL OSTEOCHONDROMATOSIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| UPPER SHOULDER/CERVICAL SPINE PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| BENIGN TUMOR FOUND | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | Systematic Assessment |
|
| HEADACHE WITH BLURRED VISION | Nervous system disorders | Systematic Assessment |
|
| MIGRAINE HEADACHE WITH VISUAL FIELD LOSS | Nervous system disorders | Systematic Assessment |
|
| MIGRANE HEADACHE | Nervous system disorders | Systematic Assessment |
|
| PAIN, NUMBNESS -LEFT HAND/FINGERS LOSS OF STRENGTH | Nervous system disorders | Systematic Assessment |
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| SYNCOPE | Nervous system disorders | Systematic Assessment |
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| VASCULAR ACCESS COMPLICATIONS | Nervous system disorders | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | Systematic Assessment |
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| URINARY RETENTION | Renal and urinary disorders | Systematic Assessment |
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| CHEST PAIN | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| ONGOING EXERTIONAL SHORTNESS OF BREATH | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| SHORTNESS OF BREATH | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| SOB AND BLOOD TRANSFUSION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| BLEEDING GUMS | Vascular disorders | Systematic Assessment |
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| HEMATOMA | Vascular disorders | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | Systematic Assessment |
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| POSSIBLE HEMATOMA | Vascular disorders | Systematic Assessment |
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| RECTAL BLEEDING | Vascular disorders | Systematic Assessment |
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| RIGHT GROIN HEMATOMA | Vascular disorders | Systematic Assessment |
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| RT GROIN SEROMA/HEMATOMA | Vascular disorders | Systematic Assessment |
|
| SIDE EFFECTS FROM MEDICATION DOSING | Vascular disorders | Systematic Assessment |
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There IS an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present or publish trial results after the trial is completed. Please contact Biosense Webster, Inc. for additional information.