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AMPLATZER Membranous VSD Occluder

Phase 1

Membranous Ventricular Septal Defects | Unknown | Other |Abbott Laboratories|Last Updated: Feb 4, 2019

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
UNCONTROLLEDDMC
Total Trials1
Total Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00578708Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDERPHASE1 COMPLETED 35Sep 1, 2003Sep 1, 2010Feb 4, 20196 United States
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Study Endpoints
Primary Endpoints
Closure of perimembranous Ventricular Septal Defects
5 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
AMPLATZER Membranous VSD OccluderDEVICEDevice closure with the AMPLATZER Membranous VSD Occluder
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Eligibility Criteria
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Patients with hemodynamically significant Perimembranous ventricular septal defects Exclusion Criteria: * Patients \< 8 kg * Supracristal ventricular septal defects * Left ventricle to right atrium shunting * Prolapse of the aortic valve * Right to left shunting through the ...

Countries:United States
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