Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study
NCT00586378 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 85
Last updated 2012-03-02
Summary
The purpose of this post-approval study is to confirm the safety and effectiveness of Ovatio DR and VR ICDs
Conditions
Interventions
- DEVICE
-
Ovatio DR and Ovatio VR
implantable cardioverter defibrillator
Sponsors & Collaborators
-
ELA Medical, Inc.
lead INDUSTRY
Principal Investigators
-
Mark J Schwartz, MS · ELA Medical, Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-04-30
- Primary Completion
- 2009-12-31
- Completion
- 2009-12-31
Countries
- United States
Study Locations
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