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Prospective, multi-center, single arm, post approval study to be conducted in the United States.
Evaluate the effectiveness of Boston Scientific (BSC)'s LV MSP (Left Ventricular MultiSite Pacing) feature in the Resonate family of CRT-D devices and confirm safety in a post approval study when used in accordance with its approved labeling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Other | General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT-D | Device | Left Ventricular MultiSite Pacing |
|
| Measure | Description | Time Frame |
|---|---|---|
| LV MSP Feature Related Complication-Free Rate | Proportion of subjects free from LVMSP feature related complications at 12 months | Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration. |
| Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months | Proportion of non-responders with LV MSP enabled at 6 months who were responders at 12 months. Responders were defined as having an Improved Clinical Composite Score at 12 Months. | 12 Month Follow Up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saba Samir | University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile Infirmary Medical Center | Mobile | Alabama | 36604 | United States | ||
| Phoenix Cardiovascular Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use. CRT-D: Left Ventricular MultiSite Pacing |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2017 |
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| Phoenix |
| Arizona |
| 85006 |
| United States |
| Cardiology Associates of NEA | Jonesboro | Arkansas | 72401 | United States |
| Foothill Cardiology Medical Group | Arcadia | California | 91007 | United States |
| Chula Vista Cardiac Center | Chula Vista | California | 91910 | United States |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | United States |
| Desert Heart Rhythm Consultants | Palm Springs | California | 92262 | United States |
| Cardiology Associates Medical Group | Ventura | California | 93003 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
| Delray Medical Center | Delray Beach | Florida | 33484 | United States |
| UF Health Jacksonville | Jacksonville | Florida | 32209 | United States |
| Florida Hospital Waterman | Lake Mary | Florida | 32746 | United States |
| Tallahassee Research Institute | Tallahassee | Florida | 32308 | United States |
| Augusta University | Augusta | Georgia | 30912 | United States |
| Alexian Brothers Hospital Network | Elk Grove Village | Illinois | 60007 | United States |
| Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| Parkview Hospital Inc | Fort Wayne | Indiana | 46845 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Norton Heart Specialist | Louisville | Kentucky | 40205 | United States |
| Advanced Cardiovascular Specialists | Shreveport | Louisiana | 71105 | United States |
| MedStar Heart and Vascular Institute | Baltimore | Maryland | 21237 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Ascension St. John Hospital & Medical Center | Detroit | Michigan | 48236 | United States |
| Genesys Regional Medical Center | Grand Blanc | Michigan | 48439 | United States |
| St. Mary's of Michigan Research Institute at Covenant Medical Ceter | Saginaw | Michigan | 48601 | United States |
| UMMC- Division of Cardiology | Jackson | Mississippi | 39216 | United States |
| St. Lukes Hospital | Kansas City | Missouri | 64111 | United States |
| Billings Clinic | Billings | Montana | 59101 | United States |
| Methodist Physicians Clinic Heart Consultants | Omaha | Nebraska | 68114 | United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | United States |
| Hackensack University Medical Canter | Hackensack | New Jersey | 07601 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Durham VA medical Center | Durham | North Carolina | 27705 | United States |
| WakeMed | Raleigh | North Carolina | 27610 | United States |
| Trihealth- Good Samaritan & Bethesda North Hospitals | Cincinnati | Ohio | 45220 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| St. Elizabeth Youngstown Hospital | Youngstown | Ohio | 44501 | United States |
| Salem Health | Salem | Oregon | 97301 | United States |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | United States |
| Pinnacle Health Cardiovascular Institute | Wormleysburg | Pennsylvania | 17043 | United States |
| Berk Cardiologists | Wyomissing | Pennsylvania | 19610 | United States |
| AnMed Health Clinical Research | Anderson | South Carolina | 29621 | United States |
| Rapid City Regional Health | Rapid City | South Dakota | 75501 | United States |
| Stern Cardiovascular Foundation | Germantown | Tennessee | 38138 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Heartplace, PA | Bedford | Texas | 76021 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| UT Health | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Carient Heart and Vascular | Manassas | Virginia | 20109 | United States |
| Sentara Norfolk General | Norfolk | Virginia | 23507 | United States |
| St. Mary's Medical Center | Huntington | West Virginia | 25702 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Total subjects with non-missing values
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use. CRT-D: Left Ventricular MultiSite Pacing |
| 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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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| 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 | LV MSP Feature Related Complication-Free Rate | Proportion of subjects free from LVMSP feature related complications at 12 months | Subjects who are non-responders at the 6 month follow up and who have LVMSP enabled for for any duration between the 6th and 12 month visit | Posted | Number | 95% Confidence Interval | percentage of participants | Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration. |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months | Proportion of non-responders with LV MSP enabled at 6 months who were responders at 12 months. Responders were defined as having an Improved Clinical Composite Score at 12 Months. | Non-responders at 6 Months who had LV MSP enabled and had complete clinical composite score data, LV MSP on and achieved >93% LVa and LVb pacing | Posted | Number | 95% Confidence Interval | percentage of participants | 12 Month Follow Up |
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Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up.
Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.
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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 | Single Arm | General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use. | 19 | 584 | 131 | 584 | 72 | 584 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematological | Blood and lymphatic system disorders | Systematic Assessment |
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| Atrial Fibrillation (AF) | Cardiac disorders | Systematic Assessment |
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| Atrial Tachycardia/Other SVT (eg AVRT, AVNRT, EAT) | Cardiac disorders | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | Systematic Assessment |
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| Chest pain - Heart failure | Cardiac disorders | Systematic Assessment |
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| Dyspnea - Heart failure | Cardiac disorders | Systematic Assessment |
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| Gastrointestinal - Heart failure | Cardiac disorders | Systematic Assessment |
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| Heart failure symptoms - Unspecified | Eye disorders | Systematic Assessment |
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| Incessant VT/VT Storm | Cardiac disorders | Systematic Assessment |
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| Mitral regurgitation | Cardiac disorders | Systematic Assessment |
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| Multi-system failure - Heart failure | Cardiac disorders | Systematic Assessment |
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| Multiple Ventricular Arrhythmias | Cardiac disorders | Systematic Assessment |
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| Multiple heart failure symptoms | Cardiac disorders | Systematic Assessment |
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| Other - Heart failure patient condition- Cardiovascular | Cardiac disorders | Systematic Assessment |
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| Other - Patient condition - Cardiovascular | Cardiac disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Pericardial effusion - Unrelated (non study) procedure or device | Cardiac disorders | Systematic Assessment |
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| Pulmonary edema - Heart failure | Cardiac disorders | Systematic Assessment |
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| Renal insufficiency/failure - Heart failure | Cardiac disorders | Systematic Assessment |
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| Valvular damage/Valvular insufficiency | Cardiac disorders | Systematic Assessment |
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| Ventricular Fibrillation (VF) | Cardiac disorders | Systematic Assessment |
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| Ventricular Tachycardia (VT)/Monomorphic VT | Cardiac disorders | Systematic Assessment |
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| Weight gain - Heart failure | Cardiac disorders | Systematic Assessment |
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| Atrial (Type 1) Flutter | Cardiac disorders | Systematic Assessment |
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| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
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| Endocrine | Endocrine disorders | Systematic Assessment |
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| Chest Pain - Other | General disorders | Systematic Assessment |
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| Death | General disorders | Systematic Assessment |
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| Fatigue and Weakness | General disorders | Systematic Assessment |
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| HEENT | General disorders | Systematic Assessment |
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| Multi-System Failure | General disorders | Systematic Assessment |
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| Other-Patient Condition-Non-Cardiovascular | General disorders | Systematic Assessment |
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| Physical Trauma | General disorders | Systematic Assessment |
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| Syncope | General disorders | Systematic Assessment |
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| Fever and/or Virus | Infections and infestations | Systematic Assessment |
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| Infection (>30 days post-implant) - PG System - Subject related | Infections and infestations | Systematic Assessment |
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| Localized Infection | Infections and infestations | Systematic Assessment |
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| Systemic Infection | Infections and infestations | Systematic Assessment |
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| Hematoma - Pocket (<=30 days post-implant) | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post-surgical infection (<=30 days post-implant) | Injury, poisoning and procedural complications | Systematic Assessment |
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| Seroma - Pocket (<=30 days post-implant) | Injury, poisoning and procedural complications | Systematic Assessment |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Neurological | Nervous system disorders | Systematic Assessment |
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| Dislodgement - LV | Product Issues | Systematic Assessment |
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| Dislodgement - RA | Product Issues | Systematic Assessment |
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| Dislodgement - RV | Product Issues | Systematic Assessment |
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| Erosion - PG System - Subject related | Product Issues | Systematic Assessment |
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| Inappropriate Tachy Therapy - SVT - PG System Therapy | Product Issues | Systematic Assessment |
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| Inappropriate tachy therapy - SVT - Defibrillation lead | Product Issues | Systematic Assessment |
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| Genitourinary | Renal and urinary disorders | Systematic Assessment |
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| Renal | Renal and urinary disorders | Systematic Assessment |
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| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Integumentary | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Cerebrovascular Accident (CVA) - unspecifed | Vascular disorders | Systematic Assessment |
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| Coronary Artery Disease | Vascular disorders | Systematic Assessment |
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| Hematoma - Unrelated (non study) procedure or device | Vascular disorders | Systematic Assessment |
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| Hypotension/Orthostatic Hypotension | Vascular disorders | Systematic Assessment |
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| Myocardial Infacrtion | Vascular disorders | Systematic Assessment |
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| Pseudoaneurysm with hematoma | Vascular disorders | Systematic Assessment |
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| Pulmonary Embolism | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Premature Atrial Contraction (PAC) | Cardiac disorders | Systematic Assessment |
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| Premature Ventricular Contractions (PVC) | Cardiac disorders | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
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| Ventricular Fibrillation (VF) | Cardiac disorders | Systematic Assessment |
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| Ventricular Tachycardia (VT)/Monomorphic VT | Cardiac disorders | Systematic Assessment |
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| Weight gain - Heart failure | Cardiac disorders | Systematic Assessment |
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| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
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| Abnormal laboratory values | General disorders | Systematic Assessment |
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| Adverse reaction - Medication | General disorders | Systematic Assessment |
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| Chest pain - Other | General disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| Head, eyes, ears, nose, throat (HEENT) | General disorders | Systematic Assessment |
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| Multiple symptoms | General disorders | Systematic Assessment |
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| Other - Patient condition- Non-cardiovascular | General disorders | Systematic Assessment |
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| Physical trauma | General disorders | Systematic Assessment |
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| Localized Infection | Infections and infestations | Systematic Assessment |
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| Hematoma - Pocket (<=30 days post-implant) | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post-surgical infection (<=30 days post-implant) | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post-surgical wound discomfort/bruising/swelling | Injury, poisoning and procedural complications | Systematic Assessment |
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| Thromboembolic events | Injury, poisoning and procedural complications | Systematic Assessment |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dislodgment - RA | Product Issues | Systematic Assessment |
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| Elevated threshold - LV Lead | Product Issues | Systematic Assessment |
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| Extracardiac stimulation - LV Lead | Product Issues | Systematic Assessment |
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| Extracardiac stimulation - RV Lead | Product Issues | Systematic Assessment |
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| Inappropriate tachy therapy - NSR -Defibrillation lead | Product Issues | Systematic Assessment |
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| Inappropriate tachy therapy - SVT - Defibrillation lead | Product Issues | Systematic Assessment |
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| Pacemaker Mediated Tachycardia - PG System Therapy | Product Issues | Systematic Assessment |
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| Genitourinary | Renal and urinary disorders | Systematic Assessment |
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| Pulmonary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Integumentary | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Arterial/venous thrombolytic event | Vascular disorders | Systematic Assessment |
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| Chest pain - Ischemic | Vascular disorders | Systematic Assessment |
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| Hypotension/Orthostatic Hypotension | Vascular disorders | Systematic Assessment |
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| Peripheral vascular disease | Vascular disorders | Systematic Assessment |
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Because the study was not designed to randomize subjects to conventional CRT or LV MSP, the potential incremental benefit of LV MSP cannot be quantified.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharda Mehta | BostonScientific | 6785967330 | sharda.mehta@bsci.com |
| Nov 29, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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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