Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study

NCT00586378 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2012-03-02

No results posted yet for this study

Summary

The purpose of this post-approval study is to confirm the safety and effectiveness of Ovatio DR and VR ICDs

Conditions

Interventions

DEVICE

Ovatio DR and Ovatio VR

implantable cardioverter defibrillator

Sponsors & Collaborators

  • ELA Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark J Schwartz, MS · ELA Medical, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Entities

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 NCT00586378 on ClinicalTrials.gov