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EASYTRAK 3 Downsize Lead

Phase 2

Heart Failure | Unknown | Cardiovascular |Boston Scientific Corporation|Last Updated: Jun 24, 2009

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 Enrollment70
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00384722EASYTRAK 3 Downsize LeadPHASE2 COMPLETED 70Mar 1, 2006May 1, 2008Jun 24, 20091 United States
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Study Endpoints
Primary Endpoints
Lead-related complication-free rate at one-month
1 month
Chronic mean pacing thresholds at one-month.
1 month
Secondary Endpoints
Chronic mean R-wave amplitudes at one-month
1 month
Chronic mean pacing impedances at one-month.
1 month
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
EASYTRAK 3 Downsize LeadDEVICEEASYTRAK 3 Downsize Lead
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Must be indicated for a Guidant CRT-P or CRT-D device * Creatinine \< 2.5 mg/dL obtained no more than two weeks prior to enrollment * Age 18 or above, or of legal age to give informed consent specific to state and national law * Willing and capable of providing informed consen...

Countries:United States
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