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CONTAK RENEWAL 3 AVT

Phase 3

Heart Failure | Unknown | Cardiovascular |Boston Scientific Corporation|Last Updated: Sep 29, 2011

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 Enrollment73
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00158977CONTAK RENEWAL 3 AVTPHASE3 COMPLETED 73Nov 1, 2003Feb 1, 2008Sep 29, 20111 United States
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Study Endpoints
Primary Endpoints
Safety Endpoint: To show that the RENEWAL 3 AVT system functions safely at 3 months
3 months
Effectiveness Endpoint: To demonstrate the effective termination of induced episodes of atrial fibrillation by cardioversion
3 months
Effectiveness Endpoint: To correctly detect and classify atrial arrhythmias (AF and/or SVT) from all other rhythms
3 months
Secondary Endpoints
Safety Endpoint: Ventricular Fibrillation (VF) Detection Time
3 months
Safety Endpoint: Percent BiV Pacing
3 months
Safety Endpoint: EASYTRAK 2 Lead Complication-Free Rate
3 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
CONTAK RENEWAL 3 AVTDEVICECONTAK RENEWAL 3 AVT
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Patients who meet the following criteria should be given consideration for inclusion in the clinical investigation: * Meet all device indications and contraindications * Willing and capable of providing informed consent, undergoing a device implant, participating in all testing...

Countries:United States
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