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Ethicon TPW32 60 cm

Phase 1

Coronary Disease | Unknown | Cardiovascular |Unity Biotechnology, Inc.|Last Updated: Dec 23, 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
UNCONTROLLED
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00316368A Study to Determine the Effect of Bi-Ventricular Pacing on Cardiac Hemodynamics After Coronary Artery Bypass GraftPHASE1 COMPLETED 60Oct 1, 2006Oct 1, 2008Dec 23, 20091 Canada
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Study Endpoints
Primary Endpoints
Cardiac index
Secondary Endpoints
Intraventricular motion
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
Interventions
NameTypeDescription
Ethicon TPW32 60 cm (pacing wires x 2)DEVICE -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * All elective/emergent patients requiring isolated coronary artery bypass graft (CABG) at St. Michael's Hospital. Exclusion Criteria: * Patient's age \< 18 years. * Known atrial fibrillation. * Sinus tachycardia \> 100 beats per minute (bpm). * Post-operative CI \< 2. * High ...

Countries:Canada
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