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EASYTRAK 3 left ventricular pacing lead

Phase 2

Congestive 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 Enrollment115
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00158938Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense LeadPHASE2 COMPLETED 115May 1, 2003Nov 1, 2004Jun 25, 2007 -
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Study Endpoints
Primary Endpoints
Pacing thresholds at 6 months
Pacing impedances at 6 months
R-wave amplitudes at 6 months
6-month complication free rate
Secondary Endpoints
left ventricular bipolar pacing and sensing with RENEWAL 3 H173 safety
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
EASYTRAK 3 left ventricular pacing leadDEVICE -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Moderate to severe heart failure (NYHA Class III/IV) including left ventricular dysfunction (EF \<= 35%) and QRS duration \>= 120 ms remaining symptomatic despite stable, optimal heart failure drug therapy. * Creatinine \< 2.5 mg/dL obtained no more than two weeks prior to enr...

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