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Ovatio DR and Ovatio VR

Phase 3

Sudden Cardiac Death | Unknown | Other |LivaNova PLC|Last Updated: Mar 2, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment85
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00586378Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval StudyPHASE3 COMPLETED 85Apr 1, 2006Dec 1, 2009Mar 2, 20121 United States
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Study Endpoints
Primary Endpoints
The percentage of patients free from complications
6 months
Shock effectiveness for VT/VF
6 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Ovatio DR and Ovatio VRDEVICEimplantable cardioverter defibrillator
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

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" (Zi...

Countries:United States
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