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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Death
Death, Sudden
Heart Arrest
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014