Improve Sudden Cardiac Arrest Study
- Conditions
- Ventricular ArrythmiaSudden Cardiac Arrest
- Interventions
- Device: ICD or CRT-D Device
- Registration Number
- NCT02099721
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4222
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A: Secondary prevention patients- device implant ICD or CRT-D Device 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. Group C: 1.5 Prevention patients - device implant ICD or CRT-D Device 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. Group E: Primary, non-1.5 patients - device implant ICD or CRT-D 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 receive an ICD/CRT-D implant.
- Primary Outcome Measures
Name Time Method Time to the First Occurrence of a Ventricular Arrhythmia 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.
- Secondary Outcome Measures
Name Time Method Mortality 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). Time to all-cause mortality
Trial Locations
- Locations (88)
Shanghai Changhai Hospital
🇨🇳Shanghai, Shanghai, China
Hospital Universitario Fundación Favaloro
🇦🇷Buenos Aires, Argentina
B.M. Birla Heart Reserch Centre
🇮🇳Kolkata, India
Institut Jantung Negara - National Heart Institute
🇲🇾Kuala Lumpur, Malaysia
Russian Scientific Center of Surgery by B.V. Petrovskiy, RAMN
🇷🇺Moscow, Russian Federation
BM Birla Heart Research CentreB
🇮🇳Kolkata, India
Seoul National University Bundang Hospital
🇰🇷Gyeonggi-Do, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Real e Benemérita Associação Portuguesa de Beneficência
🇧🇷São Paulo, Sao Paulo, Brazil
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Sejong Hospital
🇰🇷Bucheon-Si, Korea, Republic of
Russian Scientific Center of Surgery by B.V. Petrovkiy, RAMN
🇷🇺Moscow, Russian Federation
Hospital Churruca
🇦🇷Buenos Aires, Argentina
INCOR - Hospital das Clínicas da Faculdade de Medicina da USP
🇧🇷São Paulo, Brazil
Govind Ballabh Pant Hospital
🇮🇳New Delhi, India
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul Saint Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Wadi El-Neel Hospital
🇪🇬Cairo, Egypt
Republican Scientific and Practical Center "Cardiology"
🇧🇾Minsk, Belarus
Lisie Hospital
🇮🇳Cochin, India
Hospital Angeles Lomas
🇲🇽Huixquilucan de Degollado, Mexico
Scientific Research Institute of Cardiology
🇷🇺Tomsk, Russian Federation
Novosibirsk Research Institute of Circulation Pathology
🇷🇺Novosibirsk, Russian Federation
Changi General Hospital
🇸🇬Singapore, Singapore
China Medical University Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital Hsin Chu Branch
🇨🇳Taipei, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Hospital Angeles Leon
🇲🇽Leon, Mexico
Instituto Cardiovascular de Buenos Aires (ICBA)
🇦🇷Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina
Care Institute of Medical Sciences (CIMS)
🇮🇳Ahmedabad, India
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
Xiamen Heart Center
🇨🇳Xiamen, Fujian, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Wuhan Asia Heart Hospital
🇨🇳Wuhan, Hubei, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
First Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Wuxi Peoples Hospital
🇨🇳Wuxi, Jiangsu, China
The General Hospital of Shenyang Military Region
🇨🇳Shenyang, Liaoning, China
The First Teaching Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
West China Hospital, Sichuan University
🇨🇳Sichuan, Sichuan, China
First People's Hospital of Yunnan Province
🇨🇳Kunming, Yunnan, China
The First Affiliated Hospital of Zhejiang University College of Medicine
🇨🇳Hangzhou, China
Zhejiang Greentown Cardiovascular Hospital
🇨🇳Hangzhou, China
Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
🇨🇳Beijing, China
The Second Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Fujian Provincial Hospital
🇨🇳Fuzhou, China
Hangzhou First People's Hospital
🇨🇳Hangzhou, Zhejiang, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, China
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
🇨🇳Guangzhou, China
The First Affiliated Hospital of Sun Yat-Sen Medical University
🇨🇳Guangzhou, China
The Second Affiliated Hospital of the Third Military Medical University
🇨🇳Chongqing, China
The Second Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, China
Guizhou Province People's Hospital
🇨🇳Guiyang, China
The Second Affiliated Hospital of Zhejiang University College of Medicine
🇨🇳Hangzhou, China
Jinhua Municipal Central Hospital
🇨🇳Jinhua, China
Renji Hospital Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China
Xinhua Hospital Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China
Fundacion Cardioinfantil
🇨🇴Bogota, Colombia
Shenzhen Sun Yat-sen Cardiovascular Hospital
🇨🇳Shenzhen, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, China
Care Hospital
🇮🇳Hyderabad, Andhra Pra, India
Zhongshan Hospital Fudan University
🇨🇳Shanghai, China
The First Affiliated Hospital Of Xi'an Jiaotong University
🇨🇳Xi'an, China
Post Graduate Institute of Medical Education & Research
🇮🇳Chandigarh, India
Medanta- The Medicity
🇮🇳Gurgaon, Haryana, India
BM Birla Heart Research Centre
🇮🇳Kolkata, W Bengal, India
King George's Medical University
🇮🇳Lucknow, Uttar Prad, India
All India Institute of Medical Sciences
🇮🇳New Delhi, India
Krishna Institute of Medical Sciences (KIMS)
🇮🇳Secunderabad, India
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Universiti Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Hospital General de Puebla
🇲🇽Puebla, Mexico
Tyumen Regional Clinical Hospital
🇷🇺Tyumen, Russian Federation
Tyumen Cardiology Center
🇷🇺Tyumen, Russian Federation
National Heart Centre Singapore
🇸🇬Singapore, Singapore
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung, Taiwan
Groote Schuur Hospital
🇿🇦Cape Town, South Africa
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Military Hospital
🇹🇳Montfleury, Tunisia
Dubai Hospital
🇦🇪Dubai, United Arab Emirates
Ruby Hall Clinic
🇮🇳Pune, Maharashtr, India
Jiangsu Province People's Hospital
🇨🇳Nanjing, China