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CompletedNCT00586378Post-OvatioUpdated Mar 2, 2012

Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study

A Phase 3 interventional study of Ovatio DR and Ovatio VR in Sudden Cardiac Death, sponsored by ELA Medical, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-02.

Sponsored by ELA Medical, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
85
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Sudden Cardiac Death
03

In context

Death, Sudden, Cardiac

314 studies on the registry are indexed under Death, Sudden, Cardiac; 80 are open to participants now.

This study's enrollment of 85 is below the median of 136 across 118 interventional studies indexed under Death, Sudden, Cardiac.

Browse Death, Sudden, Cardiac studies →

Lead sponsor

ELA Medical, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Candidates will come from the investigator's general ICD population who meet any of the accepted indications for an ICD implant according to the "ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death" (Zipes et al., JACC Vol. 48, No. 5, Sept. 2006:1064-1108).

Exclusion criteria

Exclusion Criteria:

  • Ventricular tachyarrhythmia that may have transient or reversible causes such as: acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia, sepsis, or unstable ischemic episodes
  • Incessant tachyarrhythmia
  • Implanted pacemaker
  • Primary disorder of bradyarrhythmia or atrial tachyarrhythmia
  • Of minor age
  • Pregnant
  • Participating in another clinical study
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
85 participants (actual)

Interventions

  • DeviceOvatio DR and Ovatio VR

    implantable cardioverter defibrillator

    Also known as: Ovatio DR 6550 Dual-Chamber ICD, Ovatio VR 6250 Single-Chamber ICD

06

What researchers measure

Primary outcomes

  1. The percentage of patients free from complications

    Time frame: 6 months

  2. Shock effectiveness for VT/VF

    Time frame: 6 months

07

Study locations

1 site
  • Banner Baywood
    Mesa, Arizona 85206, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00586378
Lead sponsor
ELA Medical, Inc.
Responsible party
Sponsor
First posted
Jan 4, 2008
Start date
Apr 2006
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Mar 2, 2012

Study contacts

Mark J Schwartz, MS
study director · ELA Medical, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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ELA Medical, Inc.

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