Sudden Cardiac ArrestNCT02099721
Improve Sudden Cardiac Arrest Study
A study testing ICD or CRT-D Device in people with Sudden Cardiac Arrest and Ventricular Arrythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 93 sites in 16 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Cardiac Arrest, Ventricular Arrythmia
- What is being tested?
- ICD or CRT-D Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,222 participants
- Where
- 93 sitesin 16 countries
- Study dates
- Mar 2014to 5 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
93 sites in 16 countries.
93 sites in 16 countries
China36 sites
Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
The First Hospital of Jilin University
Changchun, Jilin, 130021
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
The Second Xiangya Hospital of Central South University
Changsha
The Second Affiliated Hospital of the Third Military Medical University
Chongqing
First Hospital of Dalian Medical University
Dalian, Liaoning
Fujian Provincial Hospital
Fuzhou, 350001
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
Guangzhou, 510000
The First Affiliated Hospital of Sun Yat-Sen Medical University
Guangzhou, 510000
Guizhou Province People's Hospital
Guiyang
The First Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, Zhejiang, 310003
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006
The First Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, 310003
The Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou
Zhejiang Greentown Cardiovascular Hospital
Hangzhou
The Second Affiliated Hospital of Harbin Medical University
Harbin, 150001
Anhui Provincial Hospital
Hefei, Anhui, 230001
Jinhua Municipal Central Hospital
Jinhua
First People's Hospital of Yunnan Province
Kunming, Yunnan, 650032
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Jiangsu Province People's Hospital
Nanjing, 210029
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, 200025
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, 200127
Xinhua Hospital Shanghai Jiaotong University School of Medicine
Shanghai
Zhongshan Hospital Fudan University
Shanghai
The General Hospital of Shenyang Military Region
Shenyang, Liaoning, 110016
Shenzhen Sun Yat-sen Cardiovascular Hospital
Shenzhen, 518001
West China Hospital, Sichuan University
Sichuan, Sichuan, 610041
The First Affiliated Hospital of Soochow University
Suzhou
The First Teaching Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022
Wuxi Peoples Hospital
Wuxi, Jiangsu, 214023
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, 710061
Xiamen Heart Center
Xiamen, Fujian, 361004
India13 sites
Care Institute of Medical Sciences (CIMS)
Ahmedabad
Post Graduate Institute of Medical Education & Research
Chandigarh, 160012
Medanta- The Medicity
Gurgaon, Haryana
Care Hospital
Hyderabad, Andhra Pra
Lisie Hospital
Kochi, 682018
BM Birla Heart Research Centre
Kolkata, West Bengal, 700027
B.M. Birla Heart Reserch Centre
Kolkata, 700027
BM Birla Heart Research CentreB
Kolkata, 700027
King George's Medical University
Lucknow, Uttar Prad, 226003
All India Institute of Medical Sciences
New Delhi
Govind Ballabh Pant Hospital
New Delhi
Ruby Hall Clinic
Pune, Maharashtr
Krishna Institute of Medical Sciences (KIMS)
Secunderabad
South Korea9 sites
Sejong Hospital
Bucheon-si
Dong-A University Hospital
Busan, 602-812
Keimyung University Dongsan Medical Center
Daegu
Chonnam National University Hospital
Gwangju
Seoul National University Bundang Hospital
Gyeonggi-do
Asan Medical Center
Seoul
Korea University Anam Hospital
Seoul
Severance Hospital
Seoul
The Catholic University of Korea Seoul Saint Mary's Hospital
Seoul
Russia8 sites
Russian Scientific Center of Surgery by B.V. Petrovkiy, RAMN
Moscow, 119991
Russian Scientific Center of Surgery by B.V. Petrovskiy, RAMN
Moscow
Novosibirsk Research Institute of Circulation Pathology
Novosibirsk, 630055
Scientific Research Institute of Cardiology
Tomsk, 634012
Tyumen Regional Clinical Hospital
Tyumen, 625023
Tyumen Cardiology Center
Tyumen, 625026
Tyumen Cardiology Center
Tyumen
Tyumen Regional Clinical Hospital
Tyumen
Taiwan6 sites
Kaohsiung Veterans General Hospital
Kaohsiung City
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
National Taiwan University Hospital Hsin Chu Branch
Taipei, 10002
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Argentina4 sites
Hospital Churruca
Buenos Aires
Hospital Italiano de Buenos Aires
Buenos Aires
Hospital Universitario Fundación Favaloro
Buenos Aires
Instituto Cardiovascular de Buenos Aires (ICBA)
Buenos Aires
Mexico4 sites
Hospital Angeles Lomas
Huixquilucan de Degollado, 52763
Hospital Angeles Lomas
León, Guanajuato, 37150
Hospital Angeles Leon
León
Hospital General de Puebla
Puebla City
Brazil3 sites
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo, São Paulo, 01322
INCOR - Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, 5403-900
INCOR - Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo
Malaysia2 sites
Institut Jantung Negara - National Heart Institute
Kuala Lumpur
Universiti Malaya Medical Centre
Kuala Lumpur
Singapore2 sites
Changi General Hospital
Singapore
National Heart Centre Singapore
Singapore
About this study
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.
Read the 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.
- Conditions
- Sudden Cardiac Arrest, Ventricular Arrythmia
- Being tested
- ICD or CRT-D Device
- 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
- Medical subject headings
- Death, Sudden, Cardiac, Syncope, Ventricular Premature Complexes, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD or CRT-D DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Secondary prevention patients- device implant | Active comparator | 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. Receives: Device: ICD or CRT-D Device |
| Group B: Secondary prevention patients - no device implant | No intervention | 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. |
| Group C: 1.5 Prevention patients - device implant | Active comparator | 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. Receives: Device: ICD or CRT-D Device |
| Group D: 1.5 prevention patients - no device implant | No intervention | 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. |
| Group E: Primary, non-1.5 patients - device implant | Other | 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. Receives: Device: ICD or CRT-D Device |
| Group F: Primary, non-1.5 patients - no device | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (1)
Mortality
Time to all-cause mortality
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startMar 2014
- Primary completion15 Jul 2018
- Study completion5 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sudden Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shu Zhang, Principal investigator, Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099721
- Sponsor's protocol ID
- Improve SCA
- Status last verified
- Oct 2020
- First submitted
- 26 Mar 2014
- Last updated
- 28 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 38519982Singh 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.
PubMed 36736459Ching 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.
PubMed 34216069Zhang 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.
PubMed 31561030Singh 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.
PubMed 30320410Zhang 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.
PubMed 26037794
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improve Sudden Cardiac Arrest Study
- ClinicalTrials.gov ID
- NCT02099721
- Acronym / sponsor ID
- Improve SCA
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,222 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Mar 2014 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 31 Mar 2014 (estimated)
- Results
- Posted 28 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A: Secondary prevention patients- device implant | Active comparator | Device: ICD or CRT-D DevicePatients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects receive an ICD/CRT-D implant. |
| Group B: Secondary prevention patients - no device implant | No intervention | –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. |
| Group C: 1.5 Prevention patients - device implant | Active comparator | Device: ICD or CRT-D DevicePatients 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. |
| Group D: 1.5 prevention patients - no device implant | No intervention | –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. |
| Group E: Primary, non-1.5 patients - device implant | Other | Device: ICD or CRT-D DevicePatients 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. |
| Group F: Primary, non-1.5 patients - no device | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICD or CRT-D DeviceSubjects 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. | Device | Group A: Secondary prevention patients- device implant, Group C: 1.5 Prevention patients - device implant, Group E: Primary, non-1.5 patients - device implant |
Primary outcome
Time to the First Occurrence of a Ventricular Arrhythmia
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).
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.
1 secondary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38519982Zhao 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.
- Derived from this study: PubMed 36736459Singh 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.
- Derived from this study: PubMed 34216069Ching 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.
- Derived from this study: PubMed 31561030Zhang 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.
- Derived from this study: PubMed 30320410Singh 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.
- Derived from this study: PubMed 26037794Zhang 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu Zhang principal investigator
Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
93 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICD or CRT-D Device in people with Sudden Cardiac Arrest and Ventricular Arrythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 93 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in China, India, South Korea, Russia, Taiwan and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to the First Occurrence of a Ventricular Arrhythmia (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02099721, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.