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CONTAK RENEWAL 2/4/4HE CRT-D, EASYTRAK 2 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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment360
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00158951Device Evaluation of Contak Renewal 2and Easytrak 2 - DECREASE-HFPHASE2 COMPLETED 360 — — Mar 1, 2003Oct 1, 2004Jun 25, 20071 United States
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Study Endpoints
Primary Endpoints
Therapy Efficacy: Change in cardiac function at six-months
Therapy Safety: CRT does not increase HF related adverse events at six-months
Device Efficacy; Therapy does not affect ability to detect VF, Stable chronic LV thresholds, R-wave amplitudes and impedances
Device Safety: System complication free rate at six-months, Lead related complication free rate at six-months
Secondary Endpoints
Therapy Efficacy: Change in cardiac function and reduced HF symptoms
Therapy Safety: Continuous appropriate pacing
Device Efficacy: Stable chronic LV thresholds, R-wave amplitudes and impedances from those not selected in final programming at six-months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
CONTAK RENEWAL 2/4/4HE CRT-DDEVICE -
EASYTRAK 2 LeadDEVICE -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Meet the general indications for a CRT-D device * Moderate or severe heart failure, defined as NYHA Class III-IV despite optimal pharmacological heart failure therapy. * A 12-lead electrocardiogram (ECG) obtained no more than 90 days prior to enrollment documenting a sinus rat...

Countries:United States
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