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This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 2,000 patients with successful St. Jude Medical (SJM) Cardiac Resynchronization Therapy (CRT) MP device implant from up to 140 centers undergoing CRT implantation.
Any patient who received a market approved SJM Quadra Allure MP, Quadra Assura MP, or newer SJM CRT MP device is eligible for enrollment in the study. MultiPoint Pacing (MPP) programming guidance will be specified in the protocol. Patients will be followed for 12 months after implant. Data will be collected at Baseline (within 30 days prior to implant), Post-Implant (within 30 days following successful CRT device implant), 3, 6, 12 months and during any unscheduled follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MPP Programming | This post-market study was designed to characterize the real-world use of MPP technology in patients indicated for CRT device implant. Therefore in order to adequately characterize MPP, data from subjects with MPP programmed continuously or for at least 3 months prior to the final follow-up are reported as the MPP programming group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MPP | Device | MPP ON within 1 month post implant and then continuously programmed ON until 12 months (i.e., MPP ON for months 1-12 continuously) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of CRT Responders as Measured by the Clinical Composite Score (CCS) | The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score. A responder is defined as improved or unchanged from baseline and non-responder is defined as worsened from baseline. | One year |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life | The change in the Minnesota Living with Heart Failure (MLWHF) questionnaire score between baseline and 12 months (12 months - baseline). MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status. | baseline and one year |
| Duration of MPP Programming in Months |
Inclusion Criteria:
Exclusion Criteria:
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Patients who are indiciated for a Cardiac Resynchronization Therapy (CRT) device
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| Name | Affiliation | Role |
|---|---|---|
| Clay Cohorn | Abbott Medical Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital - Univ. of Alabama at Birmingham (UAB) | Birmingham | Alabama | 35249 | United States | ||
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This post-market study was designed to characterize the real-world use of MPP technology in patients indicated for CRT device implant. Therefore in order to adequately characterize MPP, data from subjects with MPP programmed continuously or for at least 3 months prior to the final follow-up are reported as the MPP programming group and the associated results presented.
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| ID | Title | Description |
|---|---|---|
| FG000 | MPP Programming | Data from subjects with MPP programmed continuously or for at least 3 months prior to the final follow-up are reported as the MPP programming group. |
| 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 | May 24, 2016 |
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| BiV/MPP | Device | MPP ON at the 12-month study visit and for at least 3 continuous months prior to 12-month assessment (i.e., BiV pacing ON at some point in months 1-9 and MPP ON for months 10-12) |
|
The duration of MPP programming in months in the treatment groups. |
| One year |
| Number of MPP Programming Optimizations Per Subject | The number of MPP programming optimizations per subject | One year |
| Number of Subjects With Heart Failure Hospitalization | HF event is defined as any one of the following when the subject has symptoms and/or signs consistent with congestive heart failure:
| One year |
| Number of Subjects With Cardiovascular Hospitalization | Number of subjects with cardiovascular hospitalization as reported by the sites | One year |
| Number of Subjects With Heart Failure 30-day Hospitalization | Number of subjects with heart failure 30-day hospitalization as reported by the sites | 30 days |
| Number of Deaths | Overall mortality rate for all subjects who started the trial is summarized. | One year |
| Change in Left Ventricular Ejection Fraction | Change in left ventricular ejection fraction between baseline and 12 months (12 months - baseline) | baseline and one year |
| Change in Left Ventricular End Systolic Volume | Change in left ventricular end systolic volume between baseline and 12 months (Baseline - 12 months) | baseline and one year |
| Heart Center Research, LLC. |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Integrated Medical Services | Avondale | Arizona | 85392 | United States |
| Cardiovascular Consultants Ltd | Glendale | Arizona | 85306 | United States |
| Arizona Arrhythmia Research Center | Phoenix | Arizona | 85013 | United States |
| Phoenix Cardiovascular Research Group | Phoenix | Arizona | 85018 | United States |
| John C. Lincoln North Mountain Hospital | Phoenix | Arizona | 85020 | United States |
| Arizona Arrhythmia Consultants | Scottsdale | Arizona | 85251 | United States |
| Comprehensive Cardiovascular Specialists | Alhambra | California | 91801 | United States |
| USC University Hospital | Los Angeles | California | 90033 | United States |
| Jeffrey Goodman | Los Angeles | California | 90048 | United States |
| Premier Cardiology, Inc | Newport Beach | California | 92663 | United States |
| Desert Heart Rhythm Consultants | Palm Springs | California | 92262 | United States |
| Chaparral Medical Group | Pomona | California | 91767 | United States |
| Cardiac Rhythm Specialists, Inc. | Reseda | California | 91335 | United States |
| San Diego Cardiac Center | San Diego | California | 92123 | United States |
| COR Healthcare Medical Associates | Torrance | California | 90505 | United States |
| Aurora Denver Cardiology Associates, P.C. | Aurora | Colorado | 80012 | United States |
| Cardiology Associates of Fairfield County, PC | Norwalk | Connecticut | 06851 | United States |
| Cardiac Arrhythmia Services | Boca Raton | Florida | 33422 | United States |
| Yoel R. Vivas, MD | Delray Beach | Florida | 33484 | United States |
| Heart Rhythm Solutions | Hollywood | Florida | 33021 | United States |
| Citrus Cardiology Consultants, PA | Inverness | Florida | 34452 | United States |
| St. Vincent's Medical Center | Jacksonville | Florida | 32204 | United States |
| Naushad Shaik, MD | Kissimmee | Florida | 34741 | United States |
| Jorge Diaz, M.D., P.A. | Lake Mary | Florida | 32746 | United States |
| Central Florida Medical Research | New Smyrna Beach | Florida | 32168 | United States |
| Usman R. Siddiqui, MD | Orlando | Florida | 32837 | United States |
| Sacred Heart Hospital | Pensacola | Florida | 32504 | United States |
| Brevard Cardiovascular Research Associates, Inc. | Rockledge | Florida | 32955 | United States |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | United States |
| VA Medical Center - Tampa | Tampa | Florida | 33612 | United States |
| Piedmont Athens Regional Medical Center | Athens | Georgia | 30606 | United States |
| Emory University Hospital | Atlanta | Georgia | 30342 | United States |
| Coliseum Medical Centers | Macon | Georgia | 31201 | United States |
| Redmond Regional Medical Center | Rome | Georgia | 30165 | United States |
| Illinois Heart and Vascular - Hinsdale | Hinsdale | Illinois | 60521 | United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | United States |
| Reid Health | Richmond | Indiana | 47374 | United States |
| Healient Physician Group | Leawood | Kansas | 66211 | United States |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | United States |
| Jewish Hospital | Louisville | Kentucky | 40202 | United States |
| One Health Cardiology | Owensboro | Kentucky | 42304 | United States |
| Gregory C. Sampognaro Interventional Cardiology | Monroe | Louisiana | 71201 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Advanced Cardiovascular Specialists | Shreveport | Louisiana | 71103 | United States |
| LSU Health Sciences Center | Shreveport | Louisiana | 71130 | United States |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| MedStar Health Research Institute | Hyattsville | Maryland | 20782 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Charlton Memorial Hospital | Fall River | Massachusetts | 02720 | United States |
| Trinity Health-Michigan d/b/a Michigan Heart | Ann Arbor | Michigan | 48106 | United States |
| Michigan Electrophysiology Specialists | Flushing | Michigan | 48433 | United States |
| Sparrow Clinical Research Institute | Lansing | Michigan | 48912 | United States |
| MidMichigan Medical Center-Midland | Midland | Michigan | 48670 | United States |
| Michigan Cardiovascular Institute | Saginaw | Michigan | 48601 | United States |
| Providence Hospital | Southfield | Michigan | 48075 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | United States |
| St. Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| St. Louis Heart and Vascular PC | St Louis | Missouri | 63136 | United States |
| Kearney Regional Medical Center | Kearney | Nebraska | 68845 | United States |
| BryanLGH Medical Center East | Lincoln | Nebraska | 68506-1299 | United States |
| HealthCare Partners Cardiology | Las Vegas | Nevada | 89169 | United States |
| Catholic Medical Center | Manchester | New Hampshire | 03102 | United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | United States |
| Atlantic Health System - Morristown Memorial Hospital | Morristown | New Jersey | 07962 | United States |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 08015 | United States |
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | United States |
| Presbyterian Heart Group | Albuquerque | New Mexico | 87106 | United States |
| St. Peter's Health Partners Medical Associates, PC | Albany | New York | 12205 | United States |
| Trinity Medical WNY, PC | Buffalo | New York | 14215 | United States |
| Novant Health Heart and Vascular Research Institute | Charlotte | North Carolina | 28204 | United States |
| VA Medical Center Durham | Durham | North Carolina | 27705 | United States |
| Highpoint Regional Hospital | High Point | North Carolina | 27262 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| University Hospitals Elyria Medical Center | Elyria | Ohio | 44035 | United States |
| Middletown Cardiovascular Associates | Middletown | Ohio | 45044 | United States |
| Samaritan Heart & Vascular Institute - Cardiology Dept. | Corvallis | Oregon | 97330 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822-2150 | United States |
| Presbyterian Medical Center (PA) | Philadelphia | Pennsylvania | 19104 | United States |
| Scranton Cardiovascular Physicians | Scranton | Pennsylvania | 18510 | United States |
| Cardiology Consultants of Philadelphia | Yardley | Pennsylvania | 19067 | United States |
| Pee Dee Cardiology Associates, PA | Florence | South Carolina | 29506 | United States |
| St. Francis Hospital | Greenville | South Carolina | 29601 | United States |
| Lexington Cardiology | Lexington | South Carolina | 29204 | United States |
| Mountain States Medical Group Cardiology | Johnson City | Tennessee | 37601 | United States |
| Cardiovascular Associates, PC (Wellmont Holston Valley M C) | Kingsport | Tennessee | 37660 | United States |
| Methodist University Hospital | Memphis | Tennessee | 38104 | United States |
| Austin Heart | Austin | Texas | 78756 | United States |
| HeartPlace | Bedford | Texas | 76021 | United States |
| Fort Worth Heart | Fort Worth | Texas | 76104 | United States |
| Houston Cardiovascular Associates | Houston | Texas | 77030 | United States |
| Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| South Texas Cardiovascular Consultants | San Antonio | Texas | 78201 | United States |
| Cardiology Clinic Of San Antonio Pa | San Antonio | Texas | 78229 | United States |
| Wichita Falls Heart Clinic | Wichita Falls | Texas | 76301 | United States |
| McKay-Dee Heart Services | Ogden | Utah | 84403 | United States |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | United States |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Virginia Heart - The Cardiovascular Group, P.C. | Falls Church | Virginia | 22042 | United States |
| Bayview Physicians Services, PC | Virginia Beach | Virginia | 23454 | United States |
| Kootenai Heart Clinics | Spokane | Washington | 92204 | United States |
| St. Mary's Hospital | Huntington | West Virginia | 25702 | United States |
| Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| Aspirus Wausau Hospital | Wausau | Wisconsin | 54401 | United States |
| Wheaton Franciscan Medical Group - Heart Rhythm Specialists | Wauwatosa | Wisconsin | 53226 | United States |
| Instituto Argentino de Diagnostico y Tratamiento | Caba | Buenos Aires | C1122AAL | Argentina |
| Fundacion Favaloro para la Docencia e Inv. med. | Buenos Aires | Rio de La Plata | C1093AAS | Argentina |
| Instituto Cardiovascular Buenos Aires (ICBA) | Buenos Aires | Rio de La Plata | C1428ART | Argentina |
| Fundacion Clinica Shaio | Bogota | Antioquia | 110111 | Colombia |
| APEX Foundation | Medellín | Antioquia | 1104 | Colombia |
| Hirosaki University Hospital | Hirosaki | Aomori | 0368203 | Japan |
| Kokura Memorial Hospital | Kitakyushu | Fukuoka | 8020001 | Japan |
| Akashi Medical Center | Hyōgo | Kinki | 6740063 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 9808574 | Japan |
| Tokyo Women's Medical University | Shinjuku-Ku | Tokyo | 1628666 | Japan |
| Chiba University | Chiba | 2608677 | Japan |
| St. Marianna University School of Medicine Hospital | Kanagawa | 2168511 | Japan |
| Shinshu University Hospital | Matsumoto | 3908621 | Japan |
| Niigata University Medical & Dental Hospital | Niigata | 9518510 | Japan |
| Sakurabashi Watanabe Hospital | Osaka | 5300001 | Japan |
| National Cerebral and Cardiovascular Center Hospital | Osaka | 5658565 | Japan |
| Osaka University Hospital | Osaka | 6560871 | Japan |
| University of Tsukuba Hospital | Tsukuba | 3058576 | Japan |
| COMPLETED | Sixteen (16) cardiovascular deaths were included in the 433 subjects who completed the trial as they met one of the endpoint of the trial. |
|
| NOT COMPLETED |
|
|
Subjects programmed with MPP are included in the analysis population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MPP Group | MPP Group: Subjects programmed with MPP in the study are included in the analysis population. |
| 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 | Age |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Quality of Life (MLWHF) | MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status. | A baseline population differs from the overall due to missing data points. | Mean | Standard Deviation | scores on a scale |
| |||||||||||||||
| Left Ventricular Ejection Fraction | A baseline population differs from the overall due to missing data points. | Mean | Standard Deviation | Percentage |
| ||||||||||||||||
| Left Ventricular End-Systolic Volume | A baseline population differs from the overall due to missing data points. | Mean | Standard Deviation | mL |
|
| 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 CRT Responders as Measured by the Clinical Composite Score (CCS) | The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score. A responder is defined as improved or unchanged from baseline and non-responder is defined as worsened from baseline. | The analysis population includes any subjects whose device is programmed with MPP. | Posted | Count of Participants | Participants | One year |
|
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Change in Quality of Life | The change in the Minnesota Living with Heart Failure (MLWHF) questionnaire score between baseline and 12 months (12 months - baseline). MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status. | The analysis population includes any subjects whose device is programmed with MPP. | Posted | Mean | Standard Deviation | score on a scale | baseline and one year |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Duration of MPP Programming in Months | The duration of MPP programming in months in the treatment groups. | The analysis population includes any subjects whose device is programmed with MPP. | Posted | Mean | Standard Deviation | Months | One year |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Number of MPP Programming Optimizations Per Subject | The number of MPP programming optimizations per subject | The analysis population includes any subjects whose device is programmed with MPP. | Posted | Mean | Standard Deviation | programming optimizations | One year |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Number of Subjects With Heart Failure Hospitalization | HF event is defined as any one of the following when the subject has symptoms and/or signs consistent with congestive heart failure:
| The analysis population includes any subjects whose device is programmed with MPP. | Posted | Count of Participants | Participants | One year |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Subjects With Cardiovascular Hospitalization | Number of subjects with cardiovascular hospitalization as reported by the sites | The analysis population includes any subjects whose device is programmed with MPP. | Posted | Count of Participants | Participants | One year |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Subjects With Heart Failure 30-day Hospitalization | Number of subjects with heart failure 30-day hospitalization as reported by the sites | The analysis population includes any subjects whose device is programmed with MPP. | Posted | Count of Participants | Participants | 30 days |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Deaths | Overall mortality rate for all subjects who started the trial is summarized. | The analysis population includes any subjects who started the trial. | Posted | Count of Participants | Participants | One year |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Change in Left Ventricular Ejection Fraction | Change in left ventricular ejection fraction between baseline and 12 months (12 months - baseline) | The analysis population includes any subjects whose device is programmed with MPP. LVEF was optional data point in the study. Results were available from a very small number of subjects. | Posted | Mean | Standard Deviation | percentage | baseline and one year |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Change in Left Ventricular End Systolic Volume | Change in left ventricular end systolic volume between baseline and 12 months (Baseline - 12 months) | The analysis population includes any subjects whose device is programmed with MPP. LVESV was optional data point in the study. Results were available from a very small number of subjects. | Posted | Mean | Standard Deviation | mL | baseline and one year |
|
|
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 | Overall Study Cohort | All patients who started in the study are included in the all-cause mortality, serious adverse events and/or other adverse events tables. | 135 | 2,169 | 821 | 2,169 | 288 | 2,169 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal Labs | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Deep Vein Thrombosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Angina | Cardiac disorders | Systematic Assessment |
| ||
| Aortic Insufficiency | Cardiac disorders | Systematic Assessment |
| ||
| Aortic Stenosis | Cardiac disorders | Systematic Assessment |
| ||
| Atherosclerotic Cardiovascular Disease | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Arrhythmias | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Sarcoidosis | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Tamponade | Cardiac disorders | Systematic Assessment |
| ||
| Cardiogenic Shock | Cardiac disorders | Systematic Assessment |
| ||
| Carotid Stenosis | Cardiac disorders | Systematic Assessment |
| ||
| Chest Pain | Cardiac disorders | Systematic Assessment |
| ||
| Dilated Cardiomyopathy | Cardiac disorders | Systematic Assessment |
| ||
| Heart Failure Exacerbation | Cardiac disorders | Systematic Assessment |
| ||
| Hypotension | Cardiac disorders | Systematic Assessment |
| ||
| Hypotensive Shock | Cardiac disorders | Systematic Assessment |
| ||
| Lightheadedness | Cardiac disorders | Systematic Assessment |
| ||
| Loss Of Capture | Cardiac disorders | Systematic Assessment |
| ||
| Mitral Regurgitation | Cardiac disorders | Systematic Assessment |
| ||
| Multi-Organ Failure | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| Non-St-Elevation Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
| ||
| Pulmonary Edema | Cardiac disorders | Systematic Assessment |
| ||
| Syncope | Cardiac disorders | Systematic Assessment |
| ||
| Valve Damage | Cardiac disorders | Systematic Assessment |
| ||
| Heart Failure Exacerbation | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Abnormal Labs | Endocrine disorders | Systematic Assessment |
| ||
| Diabetes | General disorders | Systematic Assessment |
| ||
| Bowel Obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cholelithiasis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dehydration | General disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Excessive Bleeding | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gallstone | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal Bleeding | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Peritonits | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abnormal Labs | General disorders | Systematic Assessment |
| ||
| Accidental Injury | General disorders | Systematic Assessment |
| ||
| Allergic Reaction | General disorders | Systematic Assessment |
| ||
| Altered Mental Status | General disorders | Systematic Assessment |
| ||
| Anemia | General disorders | Systematic Assessment |
| ||
| Ascites | General disorders | Systematic Assessment |
| ||
| Cardiac Arrest | General disorders | Systematic Assessment |
| ||
| Cardiac Arrhythmias | General disorders | Systematic Assessment |
| ||
| Cardio-Respiratory Failure | General disorders | Systematic Assessment |
| ||
| Chest Pain | General disorders | Systematic Assessment |
| ||
| Confusion | General disorders | Systematic Assessment |
| ||
| Death | General disorders | Systematic Assessment |
| ||
| Dehydration | General disorders | Systematic Assessment |
| ||
| Device Discharge | General disorders | Systematic Assessment |
| ||
| Diarrhea | General disorders | Systematic Assessment |
| ||
| Drug Toxicity | General disorders | Systematic Assessment |
| ||
| Dyspnea | General disorders | Systematic Assessment |
| ||
| Encephalopathy | General disorders | Systematic Assessment |
| ||
| Excessive Bleeding | General disorders | Systematic Assessment |
| ||
| Gastrointestinal Bleeding | General disorders | Systematic Assessment |
| ||
| Heart Failure Exacerbation | General disorders | Systematic Assessment |
| ||
| Hematoma/Seroma | General disorders | Systematic Assessment |
| ||
| Hepato-Renal Failure | General disorders | Systematic Assessment |
| ||
| Hernia | General disorders | Systematic Assessment |
| ||
| Hypertension | General disorders | Systematic Assessment |
| ||
| Hypotension | General disorders | Systematic Assessment |
| ||
| Hypoxia | General disorders | Systematic Assessment |
| ||
| Medication Error | General disorders | Systematic Assessment |
| ||
| Metabolic Bone Disease | General disorders | Systematic Assessment |
| ||
| Multi-Organ Failure | General disorders | Systematic Assessment |
| ||
| Myocardial Infarction | General disorders | Systematic Assessment |
| ||
| Nausea and Vomiting | General disorders | Systematic Assessment |
| ||
| Non-Cardiac Death | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pericardial Effusion | General disorders | Systematic Assessment |
| ||
| Pleural Effusion | General disorders | Systematic Assessment |
| ||
| Pre-Syncope | General disorders | Systematic Assessment |
| ||
| Pulmonary Edema | General disorders | Systematic Assessment |
| ||
| Renal Failure | General disorders | Systematic Assessment |
| ||
| Respiratory Failure | General disorders | Systematic Assessment |
| ||
| Rhabdomyolysis | General disorders | Systematic Assessment |
| ||
| Sepsis | General disorders | Systematic Assessment |
| ||
| Syncope | General disorders | Systematic Assessment |
| ||
| Twiddler's Syndrome | General disorders | Systematic Assessment |
| ||
| Unresponsiveness | General disorders | Systematic Assessment |
| ||
| Weakness | General disorders | Systematic Assessment |
| ||
| Acute Hepatitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cirrhosis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Dyspnea | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hepatitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Allergic Reaction | Immune system disorders | Systematic Assessment |
| ||
| Endocarditis | Infections and infestations | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Septic Shock | Infections and infestations | Systematic Assessment |
| ||
| Accidental Injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cardiac Arrhythmias | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cardiac Tamponade | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cardiac/Coronary Sinus Dissection | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cardiac/Coronary Sinus Perforation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Deep Vein Thrombosis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Drug Overdose | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Excessive Bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hematoma/Seroma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Infection | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pericarditis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pneumothorax/Hemothorax | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pulmonary Edema | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pulmonary Hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Renal Failure From Contrast Media Used To Visualize Coronary Veins | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Thrombolytic or Air Embolism | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound Site Complications | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Abnormal Labs | Investigations | Systematic Assessment |
| ||
| Chest Pain | Investigations | Systematic Assessment |
| ||
| Drug Toxicity | Investigations | Systematic Assessment |
| ||
| Induced Atrial or Ventricular Arrhythmias | Investigations | Systematic Assessment |
| ||
| Rise in Threshold and Exit Block | Investigations | Systematic Assessment |
| ||
| Accidental Injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Colon Polyps | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Cerebellar Hemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| Cerebral Hemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| Cerebrovascular Accident | Nervous system disorders | Systematic Assessment |
| ||
| Glioblastoma | Nervous system disorders | Systematic Assessment |
| ||
| Stroke | Nervous system disorders | Systematic Assessment |
| ||
| Cardiac Arrhythmias | Product Issues | Systematic Assessment |
| ||
| Cardiac/Coronary Sinus Perforation | Product Issues | Systematic Assessment |
| ||
| Change in Thresholds | Product Issues | Systematic Assessment |
| ||
| Device Malfunction | Product Issues | Systematic Assessment |
| ||
| Elevated Defibrillation Threshold | Product Issues | Systematic Assessment |
| ||
| Induced Atrial or Ventricular Arrhythmias | Product Issues | Systematic Assessment |
| ||
| Infection | Product Issues | Systematic Assessment |
| ||
| Lead Dislodgement | Product Issues | Systematic Assessment |
| ||
| Lead/Port Damage | Product Issues | Systematic Assessment |
| ||
| Loss of Capture | Product Issues | Systematic Assessment |
| ||
| Loss of Pacing and/or Sensing due to Dislodgement or Mechanical Malfunction of The Pacing Lead | Product Issues | Systematic Assessment |
| ||
| Oversensing | Product Issues | Systematic Assessment |
| ||
| Pectoral/Diaphragmatic/Phrenic Nerve Stimulation | Product Issues | Systematic Assessment |
| ||
| Rise in Threshold And Exit Block | Product Issues | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Cholecystitis | Renal and urinary disorders | Systematic Assessment |
| ||
| Dialysis Shunt Occlusion | Renal and urinary disorders | Systematic Assessment |
| ||
| Kidney Stones | Renal and urinary disorders | Systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal Transplantation | Renal and urinary disorders | Systematic Assessment |
| ||
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Accidental Injury | Social circumstances | Systematic Assessment |
| ||
| Wound Site Complications | Surgical and medical procedures | Systematic Assessment |
| ||
| Aneurysm | Vascular disorders | Systematic Assessment |
| ||
| AV Fistula | Vascular disorders | Systematic Assessment |
| ||
| Carotid Stenosis | Vascular disorders | Systematic Assessment |
| ||
| Cerebrovascular Accident | Vascular disorders | Systematic Assessment |
| ||
| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Excessive Bleeding | Vascular disorders | Systematic Assessment |
| ||
| Limb Ischemia | Vascular disorders | Systematic Assessment |
| ||
| Occluded Stent | Vascular disorders | Systematic Assessment |
| ||
| Peripheral Artery Disease | Vascular disorders | Systematic Assessment |
| ||
| Peripheral Vascular Disease | Vascular disorders | Systematic Assessment |
| ||
| Ruptured Abdominal Aortic Aneurysm | Vascular disorders | Systematic Assessment |
| ||
| Stroke | Vascular disorders | Systematic Assessment |
| ||
| Thrombolytic or Air Embolism | Vascular disorders | Systematic Assessment |
| ||
| Transient Ischemic Attack | Vascular disorders | Systematic Assessment |
| ||
| Ulcer | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombolytic or Air Embolism | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Cardiac Arrhythmias | Cardiac disorders | Systematic Assessment |
| ||
| Dyspnea | Cardiac disorders | Systematic Assessment |
| ||
| Heart Failure Exacerbation | Cardiac disorders | Systematic Assessment |
| ||
| Lead Dislodgement | General disorders | Systematic Assessment |
| ||
| Pectoral/Diaphragmatic/Phrenic Nerve Stimulation | General disorders | Systematic Assessment |
| ||
| Allergic Reaction | General disorders | Systematic Assessment |
| ||
| Altered Mental Status | General disorders | Systematic Assessment |
| ||
| Change in Thresholds | General disorders | Systematic Assessment |
| ||
| Chest Pain | General disorders | Systematic Assessment |
| ||
| Device Vibration | General disorders | Systematic Assessment |
| ||
| Dizziness | General disorders | Systematic Assessment |
| ||
| Dyspnea | General disorders | Systematic Assessment |
| ||
| Hematoma/Seroma | General disorders | Systematic Assessment |
| ||
| Hypertension | General disorders | Systematic Assessment |
| ||
| Hypotension | General disorders | Systematic Assessment |
| ||
| Lead Dislodgement | General disorders | Systematic Assessment |
| ||
| Loss of Capture | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Loss Of CapturePectoral/Diaphragmatic/Phrenic Nerve Stimulation | General disorders | Systematic Assessment |
| ||
| Pre-Syncope | General disorders | Systematic Assessment |
| ||
| Syncope | General disorders | Systematic Assessment |
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| Weakness | General disorders | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Accidental Injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Anemia | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cardiac/Coronary Sinus Dissection | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Deep Vein Thrombosis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Excessive Bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hematoma/Seroma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Infection | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pericardial Effusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Thrombolytic or Air Embolism | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Transient Ischemic Attack | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound Site Complications | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Increased Impedance | Investigations | Systematic Assessment |
| ||
| Induced Atrial or Ventricular Arrhythmias | Investigations | Systematic Assessment |
| ||
| Change in Thresholds | Product Issues | Systematic Assessment |
| ||
| Device Discharge | Product Issues | Systematic Assessment |
| ||
| Inappropriate Therapy | Product Issues | Systematic Assessment |
| ||
| Induced Atrial or Ventricular Arrhythmias | Product Issues | Systematic Assessment |
| ||
| Lead Dislodgement | Product Issues | Systematic Assessment |
| ||
| Lead/Port Damage | Product Issues | Systematic Assessment |
| ||
| Loss of Capture | Product Issues | Systematic Assessment |
| ||
| Loss of Pacing and/or Sensing due to Dislodgement or Mechanical Malfunction of The Pacing Lead | Product Issues | Systematic Assessment |
| ||
| LV Lead Stylet Malfunction | Product Issues | Systematic Assessment |
| ||
| Oversensing | Product Issues | Systematic Assessment |
| ||
| Pectoral/Diaphragmatic/Phrenic Nerve Stimulation | Product Issues | Systematic Assessment |
| ||
| Rise in Threshold and Exit Block | Product Issues | Systematic Assessment |
| ||
| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kwangdeok Lee, PhD | Abbott | 1-972-526-9673 | kwangdeok.lee@abbott.com |
| Dec 9, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
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| Japan |
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