Study Results
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View full resultsBasic Information
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COMPLETED
NA
4222 participants
INTERVENTIONAL
2014-03-31
2018-09-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group A: Secondary prevention patients- device implant
Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest.
These subjects receive an ICD/CRT-D implant.
ICD or CRT-D Device
Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
Group B: Secondary prevention patients - no device implant
Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest.
These subjects choose not to receive an ICD/CRT-D implant.
No interventions assigned to this group
Group C: 1.5 Prevention patients - device implant
Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).
These subjects receive an ICD/CRT-D implant.
ICD or CRT-D Device
Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
Group D: 1.5 prevention patients - no device implant
Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).
These subjects choose not to receive an ICD/CRT-D implant.
No interventions assigned to this group
Group E: Primary, non-1.5 patients - device implant
Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group.
These subjects receive an ICD/CRT-D implant.
ICD or CRT-D Device
Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
Group F: Primary, non-1.5 patients - no device
Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group.
These subjects choose not to receive an ICD/CRT-D implant.
No interventions assigned to this group
Interventions
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ICD or CRT-D Device
Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
Eligibility Criteria
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Inclusion Criteria
* Subject (or subject's legally authorized representative) is willing and able to sign and date the Patient Informed Consent Form.
Exclusion Criteria
* Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader
* Subject has any contraindication for ICD/CRT-D
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Shu Zhang
Role: PRINCIPAL_INVESTIGATOR
Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
Locations
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Hospital Churruca
Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
Hospital Universitario Fundación Favaloro
Buenos Aires, , Argentina
Instituto Cardiovascular de Buenos Aires (ICBA)
Buenos Aires, , Argentina
Republican Scientific and Practical Center "Cardiology"
Minsk, , Belarus
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo, São Paulo, Brazil
INCOR - Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, , Brazil
INCOR - Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, , Brazil
Anhui Provincial Hospital
Hefei, Anhui, China
Xiamen Heart Center
Xiamen, Fujian, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Wuxi Peoples Hospital
Wuxi, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
First Hospital of Dalian Medical University
Dalian, Liaoning, China
The General Hospital of Shenyang Military Region
Shenyang, Liaoning, China
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Sichuan, Sichuan, China
The First Teaching Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
First People's Hospital of Yunnan Province
Kunming, Yunnan, China
The First Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, Zhejiang, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, , China
The Second Xiangya Hospital of Central South University
Changsha, , China
The Second Affiliated Hospital of the Third Military Medical University
Chongqing, , China
Fujian Provincial Hospital
Fuzhou, , China
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
Guangzhou, , China
The First Affiliated Hospital of Sun Yat-Sen Medical University
Guangzhou, , China
Guizhou Province People's Hospital
Guiyang, , China
The First Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, , China
The Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, , China
Zhejiang Greentown Cardiovascular Hospital
Hangzhou, , China
The Second Affiliated Hospital of Harbin Medical University
Harbin, , China
Jinhua Municipal Central Hospital
Jinhua, , China
Jiangsu Province People's Hospital
Nanjing, , China
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, , China
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Xinhua Hospital Shanghai Jiaotong University School of Medicine
Shanghai, , China
Zhongshan Hospital Fudan University
Shanghai, , China
Shenzhen Sun Yat-sen Cardiovascular Hospital
Shenzhen, , China
The First Affiliated Hospital of Soochow University
Suzhou, , China
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, , China
Fundacion Cardioinfantil
Bogotá, , Colombia
Wadi El-Neel Hospital
Cairo, , Egypt
Care Hospital
Hyderabad, Andhra Pra, India
Medanta- The Medicity
Gurgaon, Haryana, India
Ruby Hall Clinic
Pune, Maharashtr, India
King George's Medical University
Lucknow, Uttar Prad, India
BM Birla Heart Research Centre
Kolkata, West Bengal, India
Care Institute of Medical Sciences (CIMS)
Ahmedabad, , India
Post Graduate Institute of Medical Education & Research
Chandigarh, , India
Lisie Hospital
Kochi, , India
B.M. Birla Heart Reserch Centre
Kolkata, , India
BM Birla Heart Research CentreB
Kolkata, , India
All India Institute of Medical Sciences
New Delhi, , India
Govind Ballabh Pant Hospital
New Delhi, , India
Krishna Institute of Medical Sciences (KIMS)
Secunderabad, , India
Institut Jantung Negara - National Heart Institute
Kuala Lumpur, , Malaysia
Universiti Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital Angeles Lomas
León, Guanajuato, Mexico
Hospital Angeles Lomas
Huixquilucan de Degollado, , Mexico
Hospital Angeles Leon
León, , Mexico
Hospital General de Puebla
Puebla City, , Mexico
Russian Scientific Center of Surgery by B.V. Petrovkiy, RAMN
Moscow, , Russia
Russian Scientific Center of Surgery by B.V. Petrovskiy, RAMN
Moscow, , Russia
Novosibirsk Research Institute of Circulation Pathology
Novosibirsk, , Russia
Scientific Research Institute of Cardiology
Tomsk, , Russia
Tyumen Regional Clinical Hospital
Tyumen, , Russia
Tyumen Cardiology Center
Tyumen, , Russia
Tyumen Cardiology Center
Tyumen, , Russia
Tyumen Regional Clinical Hospital
Tyumen, , Russia
Changi General Hospital
Singapore, , Singapore
National Heart Centre Singapore
Singapore, , Singapore
Groote Schuur Hospital
Cape Town, , South Africa
Sejong Hospital
Bucheon-si, , South Korea
Dong-A University Hospital
Busan, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Asan Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
The Catholic University of Korea Seoul Saint Mary's Hospital
Seoul, , South Korea
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital Hsin Chu Branch
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Military Hospital
Montfleury, , Tunisia
Dubai Hospital
Dubai, , United Arab Emirates
Countries
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References
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Zhao S, Ching CK, Huang D, Liu YB, Rodriguez-Guerrero DA, Hussin A, Kim YH, Van Dorn B, Zhou X, Singh B, Zhang S; Improve SCA Investigators. Regional disparities and risk factors of mortality among patients at high risk of sudden cardiac death in emerging countries: a nonrandomized controlled trial. BMC Med. 2024 Mar 22;22(1):130. doi: 10.1186/s12916-024-03310-5.
Singh B, Hsieh YC, Liu YB, Lin KH, Joung B, Rodriguez DA, Chasnoits AR, Huang D, Zhang S, O'Brien JE, Lexcen DR, Cerkvenik J, Van Dorn B, Ching CK. Cardioverter-defibrillator reduces mortality risk in eligible ischemic and non-ischemic cardiomyopathy patients: Sub-analysis of the multi-center Improve SCA study. Indian Heart J. 2023 Mar-Apr;75(2):115-121. doi: 10.1016/j.ihj.2023.01.010. Epub 2023 Feb 2.
Ching CK, Hsieh YC, Liu YB, Rodriguez DA, Kim YH, Joung B, Singh B, Huang D, Hussin A, Chasnoits AR, O'Brien JE, Cerkvenik J, Lexcen D, Van Dorn B, Zhang S. The mortality analysis of primary prevention patients receiving a cardiac resynchronization defibrillator (CRT-D) or implantable cardioverter-defibrillator (ICD) according to guideline indications in the improve SCA study. J Cardiovasc Electrophysiol. 2021 Aug;32(8):2285-2294. doi: 10.1111/jce.15149. Epub 2021 Jul 9.
Zhang S, Ching CK, Huang D, Liu YB, Rodriguez-Guerrero DA, Hussin A, Kim YH, Chasnoits AR, Cerkvenik J, Lexcen DR, Muckala K, Brown ML, Cheng A, Singh B; Improve SCA Investigators. Utilization of implantable cardioverter-defibrillators for the prevention of sudden cardiac death in emerging countries: Improve SCA clinical trial. Heart Rhythm. 2020 Mar;17(3):468-475. doi: 10.1016/j.hrthm.2019.09.023. Epub 2019 Sep 24.
Singh B, Zhang S, Ching CK, Huang D, Liu YB, Rodriguez DA, Hussin A, Kim YH, Chasnoits AR, Cerkvenik J, Muckala KA, Cheng A. Improving the utilization of implantable cardioverter defibrillators for sudden cardiac arrest prevention (Improve SCA) in developing countries: Clinical characteristics and reasons for implantation refusal. Pacing Clin Electrophysiol. 2018 Dec;41(12):1619-1626. doi: 10.1111/pace.13526. Epub 2018 Oct 31.
Zhang S, Singh B, Rodriguez DA, Chasnoits AR, Hussin A, Ching CK, Huang D, Liu YB, Cerkvenik J, Willey S, Kim YH. Improve the prevention of sudden cardiac arrest in emerging countries: the Improve SCA clinical study design. Europace. 2015 Nov;17(11):1720-6. doi: 10.1093/europace/euv103. Epub 2015 Jun 1.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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Improve SCA
Identifier Type: -
Identifier Source: org_study_id