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Temporary RV VVI pacing

Phase 2

Acute Myocardial Infarction | Unknown | Cardiovascular |Boston Scientific Corporation|Last Updated: Aug 31, 2010

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
RandomizedNO_TREATMENT_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00409604PROTECT : Pacing to Protect Heart for Damage From Blocked Heart Vessel and From Re-opening Blocked Vessel(s)PHASE2 COMPLETED 60Dec 1, 2006Aug 1, 2009Aug 31, 20101 Netherlands
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Study Endpoints
Primary Endpoints
Infarct size (area under the curve of creatine kinase) at baseline compared with MRI at 4 months and at 12 months
4 & 12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALStandard PCI procedure + pacing post conditioning
2NO_INTERVENTIONStandard PCI procedure
Interventions
NameTypeDescription
Temporary RV VVI pacingDEVICEtemporary pacing at the onset of revascularisation
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Clinical diagnosis of acute myocardial infarction, requiring PCI within 2 to 6 hours following symptoms * Total occlusion of a coronary artery with reference vessel diameter \>or= 3mm Exclusion Criteria: * Thrombolitics * Severe bradycardia requiring cardiac pacing * Previou...

Countries:Netherlands
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