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Extravascular ICD Pivotal Study

NCT04060680 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 393

Last updated 2024-11-19

Study results available
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Summary

Pivotal Summary:

The study is designed to demonstrate safety and efficacy of the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.

Continued Access Summary:

This study is designed to provide continued access to the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.

Conditions

  • Tachycardia
  • Ventricular Arrythmia

Interventions

DEVICE

Defibrillation using the Extravascular ICD

VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Paul Friedman, MD · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-16
Primary Completion
2022-04-28
Completion
2024-01-04
FDA Device
Yes

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Denmark
  • France
  • Hong Kong
  • Hungary
  • Italy
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Saudi Arabia
  • Spain
  • Switzerland
  • 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 NCT04060680 on ClinicalTrials.gov