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NCT00586378 Clinical Trial

Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study

Sudden Cardiac Death Clinical Trial

— Post-Ovatio  

Official title:
Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00586378
Other study ID # ITAC05
Secondary ID
Status Completed
Phase Phase 3
First received December 21, 2007
Last updated March 1, 2012
Start date April 2006
Est. completion date December 2009

Study information
Verified date March 2012
Source ELA Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 85
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Ovatio DR and Ovatio VR
implantable cardioverter defibrillator

Locations
Country Name City State
United States Banner Baywood Mesa Arizona

Sponsors (1)
Lead Sponsor Collaborator
ELA Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The percentage of patients free from complications 6 months Yes
Primary Shock effectiveness for VT/VF 6 months No
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