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Acute Study to Collect Electrical Signals From the Heart Using a Special Lead

NCT02772380 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2018-06-19

No results posted yet for this study

Summary

The main purpose of this clinical study is to collect electrograms from an investigational lead placed in an extravascular space, for development of a future Implantable Cardioverter Defibrillator (ICD) system.

Conditions

  • Tachycardia
  • Ventricular Arrhythmias

Interventions

DEVICE

Defibrillation following induction of VT/VF

Up to 10 attempts to induce two VF/VT episodes for defibrillation testing

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Hong Kong
  • Hungary
  • Netherlands
  • New Zealand
  • Poland
  • Spain
  • Taiwan
  • United Kingdom

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 NCT02772380 on ClinicalTrials.gov