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

Primary Purpose

Sudden Cardiac Death

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ovatio DR and Ovatio VR
Sponsored by
ELA Medical, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sudden Cardiac Death

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner Baywood

Outcomes

Primary Outcome Measures

The percentage of patients free from complications
Shock effectiveness for VT/VF

Secondary Outcome Measures

Full Information

First Posted
December 21, 2007
Last Updated
March 1, 2012
Sponsor
ELA Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00586378
Brief Title
Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study
Acronym
Post-Ovatio
Official Title
Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ELA Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Cardiac Death

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Ovatio DR and Ovatio VR
Other Intervention Name(s)
Ovatio DR 6550 Dual-Chamber ICD, Ovatio VR 6250 Single-Chamber ICD
Intervention Description
implantable cardioverter defibrillator
Primary Outcome Measure Information:
Title
The percentage of patients free from complications
Time Frame
6 months
Title
Shock effectiveness for VT/VF
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark J Schwartz, MS
Organizational Affiliation
ELA Medical, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Banner Baywood
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States

12. IPD Sharing Statement

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Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study

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