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CRT-D

Phase 2

Heart Failure | Unknown | Cardiovascular |Boston Scientific Corporation|Last Updated: Jun 25, 2007

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment170
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00180336Safety and Efficacy Study of RENEWAL 4 AVTPHASE2 COMPLETED 170Jul 1, 2004 -Jun 25, 20071 Germany
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Study Endpoints
Primary Endpoints
System Complication-Free Rate at 6 months
Effectiveness of LV Only/LV Offset at 6 months
Secondary Endpoints
LVESD at 6 months
Six-minute walk at 6 months
NYHA at 6 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
CRT-DDEVICE -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Indications for the device * Availability for follow-up at an approved Field Following center, at the protocol defined intervals * Willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation * Prescribed to st...

Countries:Germany
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