Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02099721
Other study ID # Improve SCA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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).
See also
  Status Clinical Trial Phase
Completed NCT05791032 - Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study N/A
Not yet recruiting NCT06063811 - Ventricular Tachycardia Ablation in LVAD Patients
Withdrawn NCT05049720 - ExtraVascular Implantable Cardiac Defibrillator Continued Access Study N/A
Completed NCT04060680 - Extravascular ICD Pivotal Study N/A
Not yet recruiting NCT04990089 - VIVO European Observational Registry
Recruiting NCT05418036 - Safety Assessment for Sotalol Protocol in Outpatient Unit Phase 4
Recruiting NCT04264455 - Evaluation of Long-term Incidence of Ventricular Arrhythmias in Patients With Acute Myocarditis
Recruiting NCT03821051 - China Structural Ventricular Arrhythmias Registry
Recruiting NCT03880708 - China Inherited Ventricular Arrhythmias Registry
Recruiting NCT03041519 - Zero-fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for the Treatment of Ventricular Arrhythmias N/A
Completed NCT03204981 - Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias N/A
Recruiting NCT04239144 - Sympathetic Denervation by Video-assisted Thoracoscopy in Control of Cardiac Arrhythmias in Patients With Chagas Disease N/A
Recruiting NCT05829993 - Development of an Artificial Intelligence Algorithm to Detect Pathological Repolarization Disorders on the ECG and the Risk of Ventricular Arrhythmias
Recruiting NCT05707637 - Bipolar Radio-frequency Ablation After Standard Unipolar Approach - Prospective Registry.
Completed NCT05357716 - Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial
Recruiting NCT06158698 - CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine Phase 3
Active, not recruiting NCT03495297 - A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing N/A
Recruiting NCT06378996 - Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring N/A
Not yet recruiting NCT06360939 - Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease N/A
Suspended NCT03502499 - Half-normal Saline in Idiopathic Left Ventricular Outflow Tract Arrhythmias Ablation N/A