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The purpose of the Improve SCA Bridge study is to characterize the care pathway flow of post-acute myocardial infarction (MI) patients as a result of standard assessments of left ventricular ejection fraction (LVEF) in the acute phase (≤14 days post- acute MI) and chronic phase (≥40-90 days post-acute MI).
To determine how many patients are referred for sudden cardiac death (SCD) risk stratification and management, indicated for implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy- defibrillator (CRT-D) implant, and how many receive such devices within 12 months of experiencing an MI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EP Referred Group | Subjects with EF ≤ 40% or meeting one of the referral criteria |
| |
| Non-Referred Group | Subjects with 40%< EF <50%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EP referred group | Behavioral | Referred for sudden cardiac death (SCD) risk stratification and management |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management | The numerator for this endpoint will be defined as the number of patients who met the clinician's determination to refer the subject for SCD risk stratification and management at any of the three follow-up visits. The denominator for this endpoint is the number of patients who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this one arm. No hypotheses were tested for this endpoint. | 3-months post-MI to 12-months post-MI |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Post-Acute MI Patients Who Are Known to be Indicated for an ICD/CRT-D Within 12 Months Post-MI | The numerator for this endpoint will be the number of subjects who were indicated for an ICD/CRT-D device during any of the three follow-up visits. The denominator will be the number of subjects who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this single arm. The analysis cannot be performed within the "referred" and "not referred" groups as patients not referred are not eligible for the secondary endpoints involving device indication or implant. No hypotheses were tested for this endpoint. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have an acute Myocardial Infarction (MI) (STEMI or Non-STEMI).
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| Name | Affiliation | Role |
|---|---|---|
| Shu Zhang | Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Heart Foundation Hospital and Research Institute | Dhaka | Bangladesh | ||||
| Gleneagles Jerudong Park Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29653653 | Result | Chew DS, Wilton SB, Kavanagh K, Southern DA, Tan-Mesiatowsky LE, Exner DV; APPROACH Investigators. Left ventricular ejection fraction reassessment post-myocardial infarction: Current clinical practice and determinants of adverse remodeling. Am Heart J. 2018 Apr;198:91-96. doi: 10.1016/j.ahj.2017.11.014. Epub 2017 Dec 5. | |
| 18984889 |
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While the study objective was to categorize patients into those who met referral criteria and those who did not, those two groups were not, strictly speaking, considered to be treatment arms. Rather, subjects in the single enrolled patients arm could, by meeting the required criteria at any of the three follow-up evaluations, be reported in the referral group. Thus the two groups were the result of the collective referral assessments and not separate study arms with a subsequent study flow.
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| ID | Title | Description |
|---|---|---|
| FG000 | Post-acute MI Patients Who Are Candidates for SCA Risk Stratification | Subjects who were enrolled in the Improve SCA Bridge Study and were not excluded due to not meeting inclusion/exclusion criteria |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 3-months |
|
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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 | May 1, 2019 | Jun 10, 2022 |
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| Non-Referred group | Behavioral | Not referred for sudden cardiac death (SCD) risk stratification and management. |
|
| 3-months post-MI to 12-months post-MI |
| Percentage of Post-Acute MI Patients Who Receive an ICD/CRT-D Within 12 Months Post-MI. | The numerator for this endpoint will be the number of subjects who received an ICD/CRT-D device during any of the three follow-up visits. The denominator for this endpoint will be the number of patients who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this single arm. The analysis cannot be performed within the "referred" and "not referred" groups as patients not referred are not eligible for the secondary endpoints involving device indication or implant. No hypotheses were tested for this endpoint. | 3-months post-MI to 12-months post-MI |
| Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD | The outcome measure will be the percentage of patients with ICD indication, who were not referred, refused referral or refused implant. The denominator will count all patients with at least one of the below:
| 3-months post-MI to 12-months post-MI |
| Percentage of Post-Acute MI Patients Who Experience Cardiovascular Mortality | The numerator for this endpoint will be the number of patients who experience cardiovascular mortality. The denominator will be the number of patients enrolled in the study. No hypotheses were tested for this endpoint. | Enrollment to 12-months post-MI |
| Evolution of the Ejection Fraction Over the Immediate Period of Post MI | The Left Ventricular Ejection Fraction (LVEF) will be measured acutely post MI (≤14 days after MI onset) and chronically (40-90 days). The acute measurement will occur over all 1491 subjects assessed at baseline, while the chronic assessment will be measured over the 1046 subjects with a 3-month LVEF assessment. This outcome will compare the average LVEF, by percent, between these two phases. No hypotheses were tested for this endpoint. | Enrollment to 3-months post-MI |
| Brunei |
| Brunei |
| Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | China |
| Peking University First Hospital | Beijing | China |
| The Second Xiangya Hospital of Central South University | Changsha | China |
| West China Hospital of Sichuan University | Chendu | China |
| Sun Yat-SEN Memorial hospital, Sun Yat-sen University | Guangzhou | China |
| Guizhou Provincial People's Hospital | Guizhou | China |
| Hangzhou First People Hospital | Hangzhou | China |
| Sir Run Run Shaw Hospital School of Medicine Zhejiang University | Hangzhou | China |
| The first Hospital of Lanzhou Hospital | Lanzhou | China |
| Nanjing First Hospital | Nanjing | China |
| Shanghai Chest Hospital | Shanghai | China |
| Sichuan Provincial People's Hospital | Sichuan | China |
| Wuhan Asia heart hospital | Wuhan | China |
| Xiamen Cardiovascular Hospital | Xiamen | China |
| The First Affiliated Hospital of Xinjiang Medical University | Xinjiang | China |
| International Cardic Center | Alexandria | Egypt |
| The Madras Medical Mission | Chennai | India |
| Eternal Hospital | Jaipur | India |
| Kasturba Medical College Hospital | Mangalore | India |
| Batra Hospital and Medical Research Centre (BHMRC) | New Delhi | India |
| Fortis Escorts Heart Institute | New Delhi | India |
| National Cardiovascular Center Harapan Kita | Jakarta | Indonesia |
| Rumah Sakit Cipto Mangunkusumo | Jakarta | Indonesia |
| Hospital Serdang | Kajang | Malaysia |
| Queen Elizabeth II Hospital | Kota Kinabalu | Malaysia |
| Sarawak Heart Centre | Kota Samarahan | Malaysia |
| National Institute of Cardiovascular Diseases | Karachi | Pakistan |
| Chinese General Hospital and Medical Center | Manila | Philippines |
| King Fahad Armed Forces Hospital | Jeddah | Saudi Arabia |
| Prince Sultan Cardiac Center | Riyadh | Saudi Arabia |
| Changi General Hospital | Singapore | Singapore |
| Mediclinic Panorama | Cape Town | South Africa |
| Netcare Unitas Hospital | Pretoria | South Africa |
| Chonnam National University Hospital | Gwangju | South Korea |
| Sejong General Hospital | Gyeonggi-do | South Korea |
| Pusan National University Yangsan Hospital | Pusan | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Keimyung University Dongsan Medical Center | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Bundang Hospital | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Kaohsiung Chang Gung Memorial Hospital of CGMF | Kaohsiung City | Taiwan |
| Far Eastern Memorial Hospital | New Taipei City | Taiwan |
| China Medical University Hospital | Taichung | Taiwan |
| Mackay Memorial Hospital | Taipei | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Linkou Chang Gung Memorial Hospital | Taoyuan | Taiwan |
| King Chulalongkorn Memorial Hospital | Bangkok | Thailand |
| The Military Hospital of Tunis | Montfleury | Tunisia |
| Adabag AS, Therneau TM, Gersh BJ, Weston SA, Roger VL. Sudden death after myocardial infarction. JAMA. 2008 Nov 5;300(17):2022-9. doi: 10.1001/jama.2008.553. |
| 29150533 | Result | Chia YMF, Teng TK, Tan ESJ, Tay WT, Richards AM, Chin CWL, Shimizu W, Park SW, Hung CL, Ling LH, Ngarmukos T, Omar R, Siswanto BB, Narasimhan C, Reyes EB, Yu CM, Anand I, MacDonald MR, Yap J, Zhang S, Finkelstein EA, Lam CSP. Disparity Between Indications for and Utilization of Implantable Cardioverter Defibrillators in Asian Patients With Heart Failure. Circ Cardiovasc Qual Outcomes. 2017 Nov;10(11):e003651. doi: 10.1161/CIRCOUTCOMES.116.003651. |
| 23299937 | Result | O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the American College of Emergency Physicians and Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2013 Jul 1;82(1):E1-27. doi: 10.1002/ccd.24776. Epub 2013 Jan 8. No abstract available. |
| 36518723 | Derived | Zhang S, Chen WJ, Sankardas MA, Ahmed WH, Liew HB, Gwon HC, Nesa Malik FT, Tang B, Haggui A, Oh IY, Ong TK, Cheng CI, Liu X, Seth A, Choi YJ, Qamar N, Rungpradubvong V, Wang CC, Jeon J, Wong G, Lemme F, Van Dorn B, Lexcen D, Huang D; Improve Sudden Cardiac Arrest Bridge Investigators. Improve the Prevention of Sudden Cardiac Arrest in Patients With Post-Acute Myocardial Infarction. JACC Asia. 2022 Sep 20;2(5):559-571. doi: 10.1016/j.jacasi.2022.06.006. eCollection 2022 Oct. |
| COMPLETED |
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| NOT COMPLETED |
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| 6-months |
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| 12-months |
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled Subjects | Subjects who were enrolled in the Improve SCA Bridge Study and were not excluded due to not meeting inclusion/exclusion criteria |
| 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 |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management | The numerator for this endpoint will be defined as the number of patients who met the clinician's determination to refer the subject for SCD risk stratification and management at any of the three follow-up visits. The denominator for this endpoint is the number of patients who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this one arm. No hypotheses were tested for this endpoint. | Enrolled subjects who were evaluated at 3-month follow up to determine if they met referral criteria or did not meet referral criteria. | Posted | Count of Participants | Participants | 3-months post-MI to 12-months post-MI |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Post-Acute MI Patients Who Are Known to be Indicated for an ICD/CRT-D Within 12 Months Post-MI | The numerator for this endpoint will be the number of subjects who were indicated for an ICD/CRT-D device during any of the three follow-up visits. The denominator will be the number of subjects who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this single arm. The analysis cannot be performed within the "referred" and "not referred" groups as patients not referred are not eligible for the secondary endpoints involving device indication or implant. No hypotheses were tested for this endpoint. | Enrolled subjects who were evaluated at 3-month follow up to determine if they met referral criteria or did not meet referral criteria. | Posted | Count of Participants | Participants | 3-months post-MI to 12-months post-MI |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Post-Acute MI Patients Who Receive an ICD/CRT-D Within 12 Months Post-MI. | The numerator for this endpoint will be the number of subjects who received an ICD/CRT-D device during any of the three follow-up visits. The denominator for this endpoint will be the number of patients who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this single arm. The analysis cannot be performed within the "referred" and "not referred" groups as patients not referred are not eligible for the secondary endpoints involving device indication or implant. No hypotheses were tested for this endpoint. | Enrolled subjects who were evaluated at 3-month follow up to determine if they met referral criteria or did not meet referral criteria. | Posted | Count of Participants | Participants | 3-months post-MI to 12-months post-MI |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD | The outcome measure will be the percentage of patients with ICD indication, who were not referred, refused referral or refused implant. The denominator will count all patients with at least one of the below:
| Enrolled patients who, at the 3-month visit, met the criteria for referral for SCD risk stratification. These criteria include a reduced ejection fraction less than or equal to 40%, ventricular arrhythmia, AV block, new onset bundle branch block, or conduction abnormalities, or unexplained syncope, clinically significant palpitations or symptomatic bradycardia. | Posted | Count of Participants | Participants | 3-months post-MI to 12-months post-MI |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Post-Acute MI Patients Who Experience Cardiovascular Mortality | The numerator for this endpoint will be the number of patients who experience cardiovascular mortality. The denominator will be the number of patients enrolled in the study. No hypotheses were tested for this endpoint. | Enrolled subjects | Posted | Count of Participants | Participants | Enrollment to 12-months post-MI |
|
| ||||||||||||||||||||||||||||||
| Secondary | Evolution of the Ejection Fraction Over the Immediate Period of Post MI | The Left Ventricular Ejection Fraction (LVEF) will be measured acutely post MI (≤14 days after MI onset) and chronically (40-90 days). The acute measurement will occur over all 1491 subjects assessed at baseline, while the chronic assessment will be measured over the 1046 subjects with a 3-month LVEF assessment. This outcome will compare the average LVEF, by percent, between these two phases. No hypotheses were tested for this endpoint. | Acute LVEF measurements occurred at baseline on 1491 subjects. Chronic LVEF measurements were collected at the 3-month follow up on 1046 subjects (104 subjects were exited before the 3-month follow up, and 341 subjects did not have their LVEF measurement taken at the 3-month follow up). | Posted | Mean | Standard Deviation | Percentage of LV stroke volume | Enrollment to 3-months post-MI |
|
|
Adverse event data was collected starting at baseline through 12-month follow up.
Only deaths and cardiovascular related adverse events were collected for this study.
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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 Subjects | Subjects who were enrolled in the Improve SCA Bridge Study and were not excluded due to not meeting inclusion/exclusion criteria. While enrolled patients were separated into "Referred" and "Not-Referred" groups based on the outcomes at the 3-month visit, these groups are not separate treatment arms. It would be misleading to compare adverse events between these groups as patients not referred due to an LVEF above 50% were subsequently not followed and had relatively little exposure when compared with the referred patients. | 88 | 1,491 | 180 | 1,491 | 18 | 1,491 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Acute Left Ventricular Failure | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Acute Myocardial Infarction | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Angina Pectoris | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Angina Unstable | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Arteriosclerosis Coronary Artery | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Atrioventricular Block Complete | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Cardiac Failure | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Cardiac Failure Acute | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Cardiac Failure Chronic | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Cardiogenic Shock | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Cardiopulmonary Failure | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Coronary Artery Disease | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Intracardiac Thrombus | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Ischaemic Cardiomyopathy | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Left Ventricular Failure | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Myocardial Rupture | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Ventricular Arrhythmia | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Ventricular Fibrillation | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Ventricular Septal Defect Acquired | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Ventricular Tachycardia | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Lower Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Accidental Death | General disorders | MedDRA 24 | Systematic Assessment |
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| Chest Pain | General disorders | MedDRA 24 | Systematic Assessment |
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| Death | General disorders | MedDRA 24 | Systematic Assessment |
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| Multiple Organ Dysfunction Syndrome | General disorders | MedDRA 24 | Systematic Assessment |
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| Sudden Cardiac Death | General disorders | MedDRA 24 | Systematic Assessment |
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| Sudden Death | General disorders | MedDRA 24 | Systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Cerebellar Infarction | Nervous system disorders | MedDRA 24 | Systematic Assessment |
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| Cerebral Infarction | Nervous system disorders | MedDRA 24 | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA 24 | Systematic Assessment |
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| Embolic Stroke | Nervous system disorders | MedDRA 24 | Systematic Assessment |
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| Transient Ischaemic Attack | Nervous system disorders | MedDRA 24 | Systematic Assessment |
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| Completed Suicide | Psychiatric disorders | MedDRA 24 | Systematic Assessment |
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| Chronic Kidney Disease | Renal and urinary disorders | MedDRA 24 | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDRA 24 | Systematic Assessment |
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| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
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| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
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| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
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| Aortic Stenosis | Vascular disorders | MedDRA 24 | Systematic Assessment |
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| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA 24 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Arteriosclerosis Coronary Artery | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Atrioventricular Block | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Cardiac Aneurysm | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Cardiac Ventricular Thrombosis | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Dizziness Postural | Nervous system disorders | MedDRA 24 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 24 | Systematic Assessment |
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| Transient Ischaemic Attack | Nervous system disorders | MedDRA 24 | Systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | MedDRA 24 | Systematic Assessment |
| |
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
|
In most cases, the contract allows the principal investigator to publish their data after release of a multi-center publication per the publication strategy following Medtronic's review for disclosure of confidential information ("CI"), technical correctness, disclosure of patentable or copyrightable material, and selection and order of publications by the publications committee. Any such CI and/or item identified as not technically correct is deleted prior to publication/presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CRM Clinical Research | Medtronic Cardiac Rhythm Management | 1-800-328-2518 | rs.medtronicCRMtrials@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 7, 2019 | Jun 10, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
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