Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00586378

Acronym

Post-Ovatio

Enrollment

Registered

2008-01-04

Start date

2006-04-30

Completion date

2009-12-31

Last updated

2012-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sudden Cardiac Death

Brief summary

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

Interventions

DEVICEOvatio DR and Ovatio VR

implantable cardioverter defibrillator

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The percentage of patients free from complications	6 months
Shock effectiveness for VT/VF	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026