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Improve Sudden Cardiac Arrest Study

Primary Purpose

Sudden Cardiac Arrest, Ventricular Arrythmia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ICD or CRT-D Device
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sudden Cardiac Arrest focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Churruca
  • Hospital Italiano de Buenos Aires
  • Hospital Universitario Fundación Favaloro
  • Instituto Cardiovascular de Buenos Aires (ICBA)
  • Republican Scientific and Practical Center "Cardiology"
  • Real e Benemérita Associação Portuguesa de Beneficência
  • INCOR - Hospital das Clínicas da Faculdade de Medicina da USP
  • INCOR - Hospital das Clínicas da Faculdade de Medicina da USP
  • Anhui Provincial Hospital
  • Xiamen Heart Center
  • Wuhan Asia Heart Hospital
  • The Third Xiangya Hospital of Central South University
  • Nanjing First Hospital
  • Wuxi Peoples Hospital
  • The First Hospital of Jilin University
  • First Hospital of Dalian Medical University
  • The General Hospital of Shenyang Military Region
  • Shanghai Changhai Hospital
  • West China Hospital, Sichuan University
  • The First Teaching Hospital of Xinjiang Medical University
  • First People's Hospital of Yunnan Province
  • The First Affiliated Hospital of Zhejiang University College of Medicine
  • Hangzhou First People's Hospital
  • The Second Affiliated Hospital of Wenzhou Medical University
  • Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
  • The Second Xiangya Hospital of Central South University
  • The Second Affiliated Hospital of the Third Military Medical University
  • Fujian Provincial Hospital
  • Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
  • The First Affiliated Hospital of Sun Yat-Sen Medical University
  • Guizhou Province People's Hospital
  • The First Affiliated Hospital of Zhejiang University College of Medicine
  • The Second Affiliated Hospital of Zhejiang University College of Medicine
  • Zhejiang Greentown Cardiovascular Hospital
  • The Second Affiliated Hospital of Harbin Medical University
  • Jinhua Municipal Central Hospital
  • Jiangsu Province People's Hospital
  • Ruijin Hospital of Shanghai Jiaotong University School of Medicine
  • Renji Hospital Shanghai Jiao Tong University School of Medicine
  • Xinhua Hospital Shanghai Jiaotong University School of Medicine
  • Zhongshan Hospital Fudan University
  • Shenzhen Sun Yat-sen Cardiovascular Hospital
  • The First Affiliated Hospital of Soochow University
  • The First Affiliated Hospital Of Xi'an Jiaotong University
  • Fundacion Cardioinfantil
  • Wadi El-Neel Hospital
  • Care Hospital
  • Medanta- The Medicity
  • Ruby Hall Clinic
  • King George's Medical University
  • BM Birla Heart Research Centre
  • Care Institute of Medical Sciences (CIMS)
  • Post Graduate Institute of Medical Education & Research
  • Lisie Hospital
  • B.M. Birla Heart Reserch Centre
  • BM Birla Heart Research CentreB
  • All India Institute of Medical Sciences
  • Govind Ballabh Pant Hospital
  • Krishna Institute of Medical Sciences (KIMS)
  • Sejong Hospital
  • Dong-A University Hospital
  • Keimyung University Dongsan Medical Center
  • Chonnam National University Hospital
  • Seoul National University Bundang Hospital
  • Asan Medical Center
  • Korea University Anam Hospital
  • Severance Hospital
  • The Catholic University of Korea Seoul Saint Mary's Hospital
  • Institut Jantung Negara - National Heart Institute
  • Universiti Malaya Medical Centre
  • Hospital Angeles Lomas
  • Hospital Angeles Lomas
  • Hospital Angeles Leon
  • Hospital General de Puebla
  • Russian Scientific Center of Surgery by B.V. Petrovkiy, RAMN
  • Russian Scientific Center of Surgery by B.V. Petrovskiy, RAMN
  • Novosibirsk Research Institute of Circulation Pathology
  • Scientific Research Institute of Cardiology
  • Tyumen Regional Clinical Hospital
  • Tyumen Cardiology Center
  • Tyumen Cardiology Center
  • Tyumen Regional Clinical Hospital
  • Changi General Hospital
  • National Heart Centre Singapore
  • Groote Schuur Hospital
  • Kaohsiung Veterans General Hospital
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • National Taiwan University Hospital Hsin Chu Branch
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Military Hospital
  • Dubai Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

No Intervention

Active Comparator

No Intervention

Other

No Intervention

Arm Label

Group A: Secondary prevention patients- device implant

Group B: Secondary prevention patients - no device implant

Group C: 1.5 Prevention patients - device implant

Group D: 1.5 prevention patients - no device implant

Group E: Primary, non-1.5 patients - device implant

Group F: Primary, non-1.5 patients - no device

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Time to the First Occurrence of a Ventricular Arrhythmia
Time to the first occurrence of an episode of true ventricular tachycardia or fibrillation 24 Month rates will be provided for the two groups used in the primary endpoint definition. However, the primary endpoint of hazard ratio is presented in Statistical Analysis 1 as a ratio between Groups A and C.

Secondary Outcome Measures

Mortality
Time to all-cause mortality

Full Information

First Posted
March 26, 2014
Last Updated
October 6, 2020
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT02099721
Brief Title
Improve Sudden Cardiac Arrest Study
Official Title
Improve Sudden Cardiac Arrest Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
July 15, 2018 (Actual)
Study Completion Date
September 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: Secondary prevention patients- device implant
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B: Secondary prevention patients - no device implant
Arm Type
No Intervention
Arm Description
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.
Arm Title
Group C: 1.5 Prevention patients - device implant
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group D: 1.5 prevention patients - no device implant
Arm Type
No Intervention
Arm Description
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.
Arm Title
Group E: Primary, non-1.5 patients - device implant
Arm Type
Other
Arm Description
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.
Arm Title
Group F: Primary, non-1.5 patients - no device
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ICD or CRT-D Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to the First Occurrence of a Ventricular Arrhythmia
Description
Time to the first occurrence of an episode of true ventricular tachycardia or fibrillation 24 Month rates will be provided for the two groups used in the primary endpoint definition. However, the primary endpoint of hazard ratio is presented in Statistical Analysis 1 as a ratio between Groups A and C.
Time Frame
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 Outcome Measure Information:
Title
Mortality
Description
Time to all-cause mortality
Time Frame
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu Zhang
Organizational Affiliation
Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Churruca
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Universitario Fundación Favaloro
City
Buenos Aires
Country
Argentina
Facility Name
Instituto Cardiovascular de Buenos Aires (ICBA)
City
Buenos Aires
Country
Argentina
Facility Name
Republican Scientific and Practical Center "Cardiology"
City
Minsk
Country
Belarus
Facility Name
Real e Benemérita Associação Portuguesa de Beneficência
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01322
Country
Brazil
Facility Name
INCOR - Hospital das Clínicas da Faculdade de Medicina da USP
City
Sao Paulo
ZIP/Postal Code
5403-900
Country
Brazil
Facility Name
INCOR - Hospital das Clínicas da Faculdade de Medicina da USP
City
São Paulo
Country
Brazil
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Xiamen Heart Center
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Facility Name
Wuhan Asia Heart Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Facility Name
Wuxi Peoples Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
First Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
The General Hospital of Shenyang Military Region
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Facility Name
Shanghai Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
West China Hospital, Sichuan University
City
Sichuan
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
The First Teaching Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Facility Name
First People's Hospital of Yunnan Province
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University College of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
The Second Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Facility Name
Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
Country
China
Facility Name
The Second Affiliated Hospital of the Third Military Medical University
City
Chongqing
Country
China
Facility Name
Fujian Provincial Hospital
City
Fuzhou
ZIP/Postal Code
350001
Country
China
Facility Name
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
City
Guangzhou
ZIP/Postal Code
510000
Country
China
Facility Name
The First Affiliated Hospital of Sun Yat-Sen Medical University
City
Guangzhou
ZIP/Postal Code
510000
Country
China
Facility Name
Guizhou Province People's Hospital
City
Guiyang
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University College of Medicine
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University College of Medicine
City
Hangzhou
Country
China
Facility Name
Zhejiang Greentown Cardiovascular Hospital
City
Hangzhou
Country
China
Facility Name
The Second Affiliated Hospital of Harbin Medical University
City
Harbin
ZIP/Postal Code
150001
Country
China
Facility Name
Jinhua Municipal Central Hospital
City
Jinhua
Country
China
Facility Name
Jiangsu Province People's Hospital
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Renji Hospital Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Xinhua Hospital Shanghai Jiaotong University School of Medicine
City
Shanghai
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
Country
China
Facility Name
Shenzhen Sun Yat-sen Cardiovascular Hospital
City
Shenzhen
ZIP/Postal Code
518001
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
Country
China
Facility Name
The First Affiliated Hospital Of Xi'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710061
Country
China
Facility Name
Fundacion Cardioinfantil
City
Bogota
Country
Colombia
Facility Name
Wadi El-Neel Hospital
City
Cairo
Country
Egypt
Facility Name
Care Hospital
City
Hyderabad
State/Province
Andhra Pra
Country
India
Facility Name
Medanta- The Medicity
City
Gurgaon
State/Province
Haryana
Country
India
Facility Name
Ruby Hall Clinic
City
Pune
State/Province
Maharashtr
Country
India
Facility Name
King George's Medical University
City
Lucknow
State/Province
Uttar Prad
ZIP/Postal Code
226003
Country
India
Facility Name
BM Birla Heart Research Centre
City
Kolkata
State/Province
W Bengal
ZIP/Postal Code
700027
Country
India
Facility Name
Care Institute of Medical Sciences (CIMS)
City
Ahmedabad
Country
India
Facility Name
Post Graduate Institute of Medical Education & Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Facility Name
Lisie Hospital
City
Cochin
ZIP/Postal Code
682018
Country
India
Facility Name
B.M. Birla Heart Reserch Centre
City
Kolkata
ZIP/Postal Code
700027
Country
India
Facility Name
BM Birla Heart Research CentreB
City
Kolkata
ZIP/Postal Code
700027
Country
India
Facility Name
All India Institute of Medical Sciences
City
New Delhi
Country
India
Facility Name
Govind Ballabh Pant Hospital
City
New Delhi
Country
India
Facility Name
Krishna Institute of Medical Sciences (KIMS)
City
Secunderabad
Country
India
Facility Name
Sejong Hospital
City
Bucheon-Si
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
602-812
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-Do
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul Saint Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Institut Jantung Negara - National Heart Institute
City
Kuala Lumpur
Country
Malaysia
Facility Name
Universiti Malaya Medical Centre
City
Kuala Lumpur
Country
Malaysia
Facility Name
Hospital Angeles Lomas
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37150
Country
Mexico
Facility Name
Hospital Angeles Lomas
City
Huixquilucan de Degollado
ZIP/Postal Code
52763
Country
Mexico
Facility Name
Hospital Angeles Leon
City
Leon
Country
Mexico
Facility Name
Hospital General de Puebla
City
Puebla
Country
Mexico
Facility Name
Russian Scientific Center of Surgery by B.V. Petrovkiy, RAMN
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Russian Scientific Center of Surgery by B.V. Petrovskiy, RAMN
City
Moscow
Country
Russian Federation
Facility Name
Novosibirsk Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Facility Name
Scientific Research Institute of Cardiology
City
Tomsk
ZIP/Postal Code
634012
Country
Russian Federation
Facility Name
Tyumen Regional Clinical Hospital
City
Tyumen
ZIP/Postal Code
625023
Country
Russian Federation
Facility Name
Tyumen Cardiology Center
City
Tyumen
ZIP/Postal Code
625026
Country
Russian Federation
Facility Name
Tyumen Cardiology Center
City
Tyumen
Country
Russian Federation
Facility Name
Tyumen Regional Clinical Hospital
City
Tyumen
Country
Russian Federation
Facility Name
Changi General Hospital
City
Singapore
Country
Singapore
Facility Name
National Heart Centre Singapore
City
Singapore
Country
Singapore
Facility Name
Groote Schuur Hospital
City
Cape Town
Country
South Africa
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
National Taiwan University Hospital Hsin Chu Branch
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
Military Hospital
City
Montfleury
Country
Tunisia
Facility Name
Dubai Hospital
City
Dubai
Country
United Arab Emirates

12. IPD Sharing Statement

Citations:
PubMed Identifier
34216069
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.
Results Reference
derived
PubMed Identifier
31561030
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.
Results Reference
derived
PubMed Identifier
30320410
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.
Results Reference
derived
PubMed Identifier
26037794
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.
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Improve Sudden Cardiac Arrest Study

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