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Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study (Post-Ovatio)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00586378
Recruitment Status : Completed
First Posted : January 4, 2008
Last Update Posted : March 2, 2012
Information provided by (Responsible Party):
ELA Medical, Inc.

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

Condition or disease Intervention/treatment Phase
Sudden Cardiac Death Device: Ovatio DR and Ovatio VR Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study
Study Start Date : April 2006
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Device: Ovatio DR and Ovatio VR
    implantable cardioverter defibrillator
    Other Names:
    • Ovatio DR 6550 Dual-Chamber ICD
    • Ovatio VR 6250 Single-Chamber ICD

Primary Outcome Measures :
  1. The percentage of patients free from complications [ Time Frame: 6 months ]
  2. Shock effectiveness for VT/VF [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00586378

United States, Arizona
Banner Baywood
Mesa, Arizona, United States, 85206
Sponsors and Collaborators
ELA Medical, Inc.
Study Director: Mark J Schwartz, MS ELA Medical, Inc.

Responsible Party: ELA Medical, Inc.
ClinicalTrials.gov Identifier: NCT00586378     History of Changes
Other Study ID Numbers: ITAC05
First Posted: January 4, 2008    Key Record Dates
Last Update Posted: March 2, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Death, Sudden, Cardiac
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden