NCT00586378

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 4, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 2, 2012

Status Verified

March 1, 2012

Enrollment Period

3.7 years

First QC Date

December 21, 2007

Last Update Submit

March 1, 2012

Conditions

Sudden Cardiac Death

Outcome Measures

Primary Outcomes (2)

  • The percentage of patients free from complications

    6 months

  • Shock effectiveness for VT/VF

    6 months

Interventions

Ovatio DR and Ovatio VRDEVICE

implantable cardioverter defibrillator

Also known as: Ovatio DR 6550 Dual-Chamber ICD, Ovatio VR 6250 Single-Chamber ICD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banner Baywood

Mesa, Arizona, 85206, United States

Location

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mark J Schwartz, MS

    ELA Medical, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 4, 2008

Study Start

April 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 2, 2012

Record last verified: 2012-03

Locations

US(1)