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Extravascular ICD Pilot Study

NCT03608670 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-01-08

Study results available
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Summary

The proposed study is designed to characterize the safety and efficacy of a new extravascular implantable cardioverter defibrillator (ICD) system in humans.

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

  • Ian G Crozier, MB ChB · Christchurch Hospital, Christchurch, New Zealand

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-17
Primary Completion
2019-03-11
Completion
2023-11-15
FDA Device
Yes

Countries

  • Australia
  • New Zealand

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 NCT03608670 on ClinicalTrials.gov