Clinical trial NCT02099721: Improve Sudden Cardiac Arrest Study
Official title: Improve Sudden Cardiac Arrest Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sudden Cardiac Arrest
Ventricular Arrythmia
Keywords: Sudden Cardiac Arrest (SCA)
Syncope
Non Sustained Ventricular Tachycardia (NSVT)
Premature Ventricular Contractions (PVC)
Left Ventricular Ejection Fraction (LVEF)
Primary Prevention
Secondary Prevention
Antitachycardia pacing (ATP)
shock
appropriate therapy
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2014-03-31
Enrollment: 4222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to demonstrate that primary prevention patients with one or more additional risk factors (1.5 prevention criteria: syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent pre-ventricular contractions (PVCs), and low left ventricular ejection fraction (LVEF)) are at a similar risk of life-threatening ventricular arrhythmias (LTVA) when compared to secondary prevention patients, and would receive similar benefit from an implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy- defibrillator (CRT-D) implant.

Detailed description: Devices allowed in the study include any Medtronic single, dual, or triple chamber defibrillator that has received appropriate license or regulatory approval and is commercially available by Medtronic in the geography in which the implant will take place. Any market-released, commercially available lead(s) can be used in the study.

Eligibility criteria: Inclusion Criteria:

* Subject has a Class I indication for implantation of an ICD according to the American College of Cardiology (ACC)/American Heart Association(AHA)/Heart Rhythm Society (HRS) or European Society of Cardiology (ESC) Guidelines
* Subject (or subject's legally authorized representative) is willing and able to sign and date the Patient Informed Consent Form.

Exclusion Criteria:

* Subject is ≤ 18 years of age
* Subject with any exclusion criteria as required by local law (e.g., age, pregnancy, breast feeding)
* 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

Primary outcomes:
measure: Time to the First Occurrence of a Ventricular Arrhythmia
timeFrame: Hazard ratio from study enrollment to approximately 4 years post-implant/enrollment (as reported in Statistical Analysis 1), and estimated 24 month VT-VF rate (as compared in the Outcome Measure table between Groups A and C).
Secondary outcomes:
measure: Mortality
timeFrame: Hazard ratio from study enrollment to approximately 4 years post-implant/enrollment (as reported in Statistical Analysis 1), and estimated 24 month mortality rate (as compared in the Outcome Measure table between Groups C and D).
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Churruca
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Universitario Fundación Favaloro
city: Buenos Aires
country: Argentina
facility: Instituto Cardiovascular de Buenos Aires (ICBA)
city: Minsk
country: Belarus
facility: Republican Scientific and Practical Center "Cardiology"
city: São Paulo
country: Brazil
facility: Real e Benemérita Associação Portuguesa de Beneficência
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: INCOR - Hospital das Clínicas da Faculdade de Medicina da USP
city: São Paulo
country: Brazil
facility: INCOR - Hospital das Clínicas da Faculdade de Medicina da USP
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Xiamen
country: China
facility: Xiamen Heart Center
state: Fujian
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Peoples Hospital
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: First Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: The General Hospital of Shenyang Military Region
state: Liaoning
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
state: Shanghai
city: Sichuan
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Urumqi
country: China
facility: The First Teaching Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: First People's Hospital of Yunnan Province
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University College of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Beijing
country: China
facility: Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Chongqing
country: China
facility: The Second Affiliated Hospital of the Third Military Medical University
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-Sen Medical University
city: Guiyang
country: China
facility: Guizhou Province People's Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University College of Medicine
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University College of Medicine
city: Hangzhou
country: China
facility: Zhejiang Greentown Cardiovascular Hospital
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital
city: Nanjing
country: China
facility: Jiangsu Province People's Hospital
city: Shanghai
country: China
facility: Ruijin Hospital of Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Xinhua Hospital Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Shenzhen
country: China
facility: Shenzhen Sun Yat-sen Cardiovascular Hospital
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
city: Xi'an
country: China
facility: The First Affiliated Hospital Of Xi'an Jiaotong University
city: Bogota
country: Colombia
facility: Fundacion Cardioinfantil
city: Cairo
country: Egypt
facility: Wadi El-Neel Hospital
city: Hyderabad
country: India
facility: Care Hospital
state: Andhra Pra
city: Gurgaon
country: India
facility: Medanta- The Medicity
state: Haryana
city: Pune
country: India
facility: Ruby Hall Clinic
state: Maharashtr
city: Lucknow
country: India
facility: King George's Medical University
state: Uttar Prad
city: Kolkata
country: India
facility: BM Birla Heart Research Centre
state: W Bengal
city: Ahmedabad
country: India
facility: Care Institute of Medical Sciences (CIMS)
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education & Research
city: Cochin
country: India
facility: Lisie Hospital
city: Kolkata
country: India
facility: B.M. Birla Heart Reserch Centre
city: Kolkata
country: India
facility: BM Birla Heart Research CentreB
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: New Delhi
country: India
facility: Govind Ballabh Pant Hospital
city: Secunderabad
country: India
facility: Krishna Institute of Medical Sciences (KIMS)
city: Bucheon-Si
country: Korea, Republic of
facility: Sejong Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-Do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul Saint Mary's Hospital
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara - National Heart Institute
city: Kuala Lumpur
country: Malaysia
facility: Universiti Malaya Medical Centre
city: Leon
country: Mexico
facility: Hospital Angeles Lomas
state: Guanajuato
city: Huixquilucan de Degollado
country: Mexico
facility: Hospital Angeles Lomas
city: Leon
country: Mexico
facility: Hospital Angeles Leon
city: Puebla
country: Mexico
facility: Hospital General de Puebla
city: Moscow
country: Russian Federation
facility: Russian Scientific Center of Surgery by B.V. Petrovkiy, RAMN
city: Moscow
country: Russian Federation
facility: Russian Scientific Center of Surgery by B.V. Petrovskiy, RAMN
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Research Institute of Circulation Pathology
city: Tomsk
country: Russian Federation
facility: Scientific Research Institute of Cardiology
city: Tyumen
country: Russian Federation
facility: Tyumen Regional Clinical Hospital
city: Tyumen
country: Russian Federation
facility: Tyumen Cardiology Center
city: Tyumen
country: Russian Federation
facility: Tyumen Cardiology Center
city: Tyumen
country: Russian Federation
facility: Tyumen Regional Clinical Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital Hsin Chu Branch
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Montfleury
country: Tunisia
facility: Military Hospital
city: Dubai
country: United Arab Emirates
facility: Dubai Hospital
Study officials:
affiliation: Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
name: Shu Zhang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.