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Avoid Transvenous Leads in Appropriate Subjects

NCT02881255 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 544

Last updated 2022-05-31

No results posted yet for this study

Summary

The purpose of the study is to compare standard, single chamber transvenous ICD to sub-cutaneous ICD in occurrence of perioperative and long term device related complications and failed appropriate clinical shocks and arrhythmic death.

Conditions

  • Ventricular Arrhythmia

Interventions

DEVICE

Implantable Cardioverter Defibrillator

Patients will be randomized to receive either a subcutaneous or transvenous ICD.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Jeff Healey, MD · Population Health Research Institute

  • Blandine Mondesert, MD · Université de Montréal

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-22
Primary Completion
2022-01-31
Completion
2022-02-10
FDA Device
Yes

Countries

  • Canada

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 NCT02881255 on ClinicalTrials.gov