Improve Sudden Cardiac Arrest Study

October 6, 2020 updated by: Medtronic Cardiac Rhythm and Heart Failure
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4222

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina
        • Hospital Churruca
      • Buenos Aires, Argentina
        • Hospital Universitario Fundacion Favaloro
      • Buenos Aires, Argentina
        • Instituto Cardiovascular de Buenos Aires (ICBA)
  • Belarus
      • Minsk, Belarus
        • Republican Scientific and Practical Center "Cardiology"
  • Brazil
      • Sao Paulo, Brazil, 5403-900
        • INCOR - Hospital das Clínicas da Faculdade de Medicina da USP
      • São Paulo, Brazil
        • INCOR - Hospital das Clínicas da Faculdade de Medicina da USP
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 01322
        • Real e Benemérita Associação Portuguesa de Beneficência
  • China
      • Beijing, China
        • Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
      • Changsha, China
        • The second Xiangya Hospital of Central South University
      • Chongqing, China
        • The Second Affiliated Hospital of the Third Military Medical University
      • Fuzhou, China, 350001
        • Fujian Provincial Hospital
      • Guangzhou, China, 510000
        • Sun Yat-sen Memorial Hospital Sun Yat-sen University
      • Guangzhou, China, 510000
        • The First Affiliated Hospital of Sun Yat-Sen Medical University
      • Guiyang, China
        • GuiZhou Province People's Hospital
      • Hangzhou, China, 310003
        • 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
      • Harbin, China, 150001
        • The Second Affiliated Hospital of Harbin Medical University
      • Jinhua, China
        • Jinhua municipal central hospital
      • Nanjing, China, 210029
        • Jiangsu Province People's Hospital
      • Shanghai, China
        • Zhongshan Hospital Fudan University
      • Shanghai, China, 200025
        • Ruijin Hospital of Shanghai Jiaotong University School of Medicine
      • Shanghai, China, 200127
        • Renji Hospital Shanghai Jiao Tong University School of Medicine
      • Shanghai, China
        • Xinhua Hospital Shanghai Jiaotong University School of Medicine
      • Shenzhen, China, 518001
        • Shenzhen Sun Yat-sen Cardiovascular Hospital
      • Suzhou, China
        • The First Affiliated Hospital of Soochow University
      • Xi'an, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
    • Anhui
      • Hefei, Anhui, China, 230001
        • Anhui Provincial Hospital
    • Fujian
      • Xiamen, Fujian, China, 361004
        • Xiamen Heart Center
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Asia Heart Hospital
    • Hunan
      • Changsha, Hunan, China, 410013
        • The Third Xiangya Hospital of Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Nanjing First Hospital
      • Wuxi, Jiangsu, China, 214023
        • Wuxi Peoples Hospital
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
    • Liaoning
      • Dalian, Liaoning, China
        • First Hospital of Dalian Medical University
      • Shenyang, Liaoning, China, 110016
        • The General Hospital Of Shenyang Military Region
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Shanghai Changhai Hospital
    • Sichuan
      • Sichuan, Sichuan, China, 610041
        • West China Hospital, Sichuan University
    • Xinjiang
      • Urumqi, Xinjiang, China, 830054
        • The First Teaching Hospital of Xinjiang Medical University
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • First People's Hospital of Yunnan Province
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Hangzhou First People's Hospital
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital of Zhejiang University College of Medicine
      • Wenzhou, Zhejiang, China, 325027
        • The Second Affiliated Hospital of Wenzhou Medical University
  • Colombia
      • Bogota, Colombia
        • Fundacion Cardioinfantil
  • Egypt
      • Cairo, Egypt
        • Wadi El-Neel Hospital
  • India
      • Ahmedabad, India
        • Care Institute of Medical Sciences (CIMS)
      • Chandigarh, India, 160012
        • Post Graduate Institute of Medical Education & Research
      • Cochin, India, 682018
        • Lisie Hospital
      • Kolkata, India, 700027
        • B.M. Birla Heart Reserch Centre
      • Kolkata, India, 700027
        • BM Birla Heart Research CentreB
      • New Delhi, India
        • All India Institute of Medical Sciences
      • New Delhi, India
        • Govind Ballabh Pant Hospital
      • Secunderabad, India
        • Krishna Institute of Medical Sciences (KIMS)
    • Andhra Pra
      • Hyderabad, Andhra Pra, India
        • Care Hospital
    • Haryana
      • Gurgaon, Haryana, India
        • Medanta- The medicity
    • Maharashtr
      • Pune, Maharashtr, India
        • Ruby Hall Clinic
    • Uttar Prad
      • Lucknow, Uttar Prad, India, 226003
        • King George's Medical University
    • W Bengal
      • Kolkata, W Bengal, India, 700027
        • BM Birla Heart Research Centre
  • Korea, Republic of
      • Bucheon-Si, Korea, Republic of
        • Sejong Hospital
      • Busan, Korea, Republic of, 602-812
        • Dong-A University Hospital
      • Daegu, Korea, Republic of
        • Keimyung University Dongsan Medical Center
      • Gwangju, Korea, Republic of
        • Chonnam National University Hospital
      • Gyeonggi-Do, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Severance Hospital
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • The Catholic University of Korea Seoul Saint Mary's Hospital
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Institut Jantung Negara - National Heart Institute
      • Kuala Lumpur, Malaysia
        • Universiti Malaya Medical Centre
  • Mexico
      • Huixquilucan de Degollado, Mexico, 52763
        • Hospital Angeles Lomas
      • Leon, Mexico
        • Hospital Angeles Leon
      • Puebla, Mexico
        • Hospital General de Puebla
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37150
        • Hospital Angeles Lomas
  • Russian Federation
      • Moscow, Russian Federation, 119991
        • Russian Scientific Center of Surgery by B.V. Petrovkiy, RAMN
      • Moscow, Russian Federation
        • Russian Scientific Center of Surgery by B.V. Petrovskiy, RAMN
      • Novosibirsk, Russian Federation, 630055
        • Novosibirsk research institute of circulation pathology
      • Tomsk, Russian Federation, 634012
        • Scientific Research Institute of Cardiology
      • Tyumen, Russian Federation, 625026
        • Tyumen Cardiology Center
      • Tyumen, Russian Federation
        • Tyumen Cardiology Center
      • Tyumen, Russian Federation, 625023
        • Tyumen Regional Clinical Hospital
      • Tyumen, Russian Federation
        • Tyumen Regional Clinical Hospital
  • Singapore
      • Singapore, Singapore
        • Changi General Hospital
      • Singapore, Singapore
        • National Heart Centre Singapore
  • South Africa
      • Cape Town, South Africa
        • Groote Schuur Hospital
  • Taiwan
      • Kaohsiung, Taiwan
        • Kaohsiung Veterans General Hospital
      • Taichung, Taiwan
        • China Medical University Hospital
      • Taichung, Taiwan
        • Taichung Veterans General Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital Hsin Chu Branch
  • Tunisia
      • Montfleury, Tunisia
        • Military Hospital
  • United Arab Emirates
      • Dubai, United Arab Emirates
        • Dubai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: Secondary prevention patients- device implant

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.
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.
No Intervention: Group B: Secondary prevention patients - no device 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.
Active Comparator: Group C: 1.5 Prevention patients - device 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.
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.
No Intervention: Group D: 1.5 prevention patients - no device 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.
Other: Group E: Primary, non-1.5 patients - device 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.
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.
No Intervention: Group F: Primary, non-1.5 patients - no 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 choose not to receive an ICD/CRT-D implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

July 15, 2018

Study Completion (Actual)

September 5, 2018

Study Registration Dates

First Submitted

March 26, 2014

First Submitted That Met QC Criteria

March 26, 2014

First Posted (Estimate)

March 31, 2014

Study Record Updates

Last Update Posted (Actual)

October 28, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Improve SCA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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