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Improve Sudden Cardiac Arrest Study

NCT02099721 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4222

Last updated 2020-10-28

Study results available
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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.

Conditions

  • Sudden Cardiac Arrest
  • Ventricular Arrythmia

Interventions

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.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Shu Zhang · Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2018-07-15
Completion
2018-09-05

Countries

  • Argentina
  • Belarus
  • Brazil
  • China
  • Colombia
  • Egypt
  • India
  • Malaysia
  • Mexico
  • Russia
  • Singapore
  • South Africa
  • South Korea
  • Taiwan
  • Tunisia
  • United Arab Emirates

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02099721 on ClinicalTrials.gov