Improve Sudden Cardiac Arrest Study

Ventricular Arrythmia Clinical Trial

Official title:

Improve Sudden Cardiac Arrest Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099721
• Other study ID #: Improve SCA
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: September 5, 2018

Study information

• Verified date: October 2020
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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 information / eligibility

• Status: Completed
• Enrollment: 4222
• Est. completion date: September 5, 2018
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Heart Arrest
• Sudden Cardiac Arrest
• Ventricular Arrythmia

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Argentina	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
Belarus	Republican Scientific and Practical Center "Cardiology"	Minsk
Brazil	INCOR - Hospital das Clínicas da Faculdade de Medicina da USP	Sao Paulo
Brazil	INCOR - Hospital das Clínicas da Faculdade de Medicina da USP	São Paulo
Brazil	Real e Benemérita Associação Portuguesa de Beneficência	São Paulo	Sao Paulo
China	Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University	Changsha
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	The Second Affiliated Hospital of the Third Military Medical University	Chongqing
China	First Hospital of Dalian Medical University	Dalian	Liaoning
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	Hangzhou First People's Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Zhejiang University College of Medicine	Hangzhou	Zhejiang
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	Anhui Provincial Hospital	Hefei	Anhui
China	Jinhua Municipal Central Hospital	Jinhua
China	First People's Hospital of Yunnan Province	Kunming	Yunnan
China	Jiangsu Province People's Hospital	Nanjing
China	Nanjing First Hospital	Nanjing	Jiangsu
China	Renji Hospital Shanghai Jiao Tong University School of Medicine	Shanghai
China	Ruijin Hospital of Shanghai Jiaotong University School of Medicine	Shanghai
China	Shanghai Changhai Hospital	Shanghai	Shanghai
China	Xinhua Hospital Shanghai Jiaotong University School of Medicine	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai
China	The General Hospital of Shenyang Military Region	Shenyang	Liaoning
China	Shenzhen Sun Yat-sen Cardiovascular Hospital	Shenzhen
China	West China Hospital, Sichuan University	Sichuan	Sichuan
China	The First Affiliated Hospital of Soochow University	Suzhou
China	The First Teaching Hospital of Xinjiang Medical University	Urumqi	Xinjiang
China	The Second Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Wuhan Asia Heart Hospital	Wuhan	Hubei
China	Wuxi Peoples Hospital	Wuxi	Jiangsu
China	The First Affiliated Hospital Of Xi'an Jiaotong University	Xi'an
China	Xiamen Heart Center	Xiamen	Fujian
Colombia	Fundacion Cardioinfantil	Bogota
Egypt	Wadi El-Neel Hospital	Cairo
India	Care Institute of Medical Sciences (CIMS)	Ahmedabad
India	Post Graduate Institute of Medical Education & Research	Chandigarh
India	Lisie Hospital	Cochin
India	Medanta- The Medicity	Gurgaon	Haryana
India	Care Hospital	Hyderabad	Andhra Pra
India	B.M. Birla Heart Reserch Centre	Kolkata
India	BM Birla Heart Research Centre	Kolkata	W Bengal
India	BM Birla Heart Research CentreB	Kolkata
India	King George's Medical University	Lucknow	Uttar Prad
India	All India Institute of Medical Sciences	New Delhi
India	Govind Ballabh Pant Hospital	New Delhi
India	Ruby Hall Clinic	Pune	Maharashtr
India	Krishna Institute of Medical Sciences (KIMS)	Secunderabad
Korea, Republic of	Sejong Hospital	Bucheon-Si
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-Do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul Saint Mary's Hospital	Seoul
Malaysia	Institut Jantung Negara - National Heart Institute	Kuala Lumpur
Malaysia	Universiti Malaya Medical Centre	Kuala Lumpur
Mexico	Hospital Angeles Lomas	Huixquilucan de Degollado
Mexico	Hospital Angeles Leon	Leon
Mexico	Hospital Angeles Lomas	Leon	Guanajuato
Mexico	Hospital General de Puebla	Puebla
Russian Federation	Russian Scientific Center of Surgery by B.V. Petrovkiy, RAMN	Moscow
Russian Federation	Russian Scientific Center of Surgery by B.V. Petrovskiy, RAMN	Moscow
Russian Federation	Novosibirsk Research Institute of Circulation Pathology	Novosibirsk
Russian Federation	Scientific Research Institute of Cardiology	Tomsk
Russian Federation	Tyumen Cardiology Center	Tyumen
Russian Federation	Tyumen Cardiology Center	Tyumen
Russian Federation	Tyumen Regional Clinical Hospital	Tyumen
Russian Federation	Tyumen Regional Clinical Hospital	Tyumen
Singapore	Changi General Hospital	Singapore
Singapore	National Heart Centre Singapore	Singapore
South Africa	Groote Schuur Hospital	Cape Town
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	National Taiwan University Hospital Hsin Chu Branch	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Tunisia	Military Hospital	Montfleury
United Arab Emirates	Dubai Hospital	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

Argentina,  Belarus,  Brazil,  China,  Colombia,  Egypt,  India,  Korea, Republic of,  Malaysia,  Mexico,  Russian Federation,  Singapore,  South Africa,  Taiwan,  Tunisia,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Mortality	Time to all-cause 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).