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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ELA Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00586378
First received: December 21, 2007
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Sudden Cardiac Death
 Device: Ovatio DR and Ovatio VR
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ELA Medical, Inc.:

Primary Outcome Measures:
  • The percentage of patients free from complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Shock effectiveness for VT/VF [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 85
Study Start Date: April 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586378

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

No publications provided

Responsible Party: ELA Medical, Inc.
ClinicalTrials.gov Identifier: NCT00586378     History of Changes
Other Study ID Numbers: ITAC05
Study First Received: December 21, 2007
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013