Recent Updates
Recently added Catalysts

Medtronic Resting Heart Bypass System

Phase 1

Coronary Artery Bypass Surgery | Unknown | Cardiovascular |Medtronic plc.|Last Updated: Aug 28, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00303641Safety and Effectiveness of the Medtronic Resting Heart Bypass System in Heart Surgery PatientsPHASE1 COMPLETED 60 — — Nov 1, 2004Feb 1, 2006Aug 28, 20171 Canada
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
C-reactive protein
Cell count
Cytokine levels
Complement
Secondary Endpoints
Postoperative blood loss, units of blood transfused, re-operation for bleeding, chest tube drainage, length of ICU stay, neurologic and renal function, infection, atrial fibrillation and overall length of postoperative hospital stay
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Medtronic Resting Heart Bypass SystemDEVICE -
Unlock Study Design Details
Eligibility Criteria
Age Range30 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Consenting patients undergoing elective surgical coronary artery bypass grafting (CABG) with use of the cardiopulmonary bypass machine Exclusion Criteria: * Patients unable to provide written informed consent * Emergency CABG surgery * Concomitant CABG + Valvular surgery * O...

Countries:Canada
Unlock Eligibility Criteria