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Pacing Lead

Phase 1

Heart Failure | Unknown | Cardiovascular |Medtronic plc.|Last Updated: Oct 12, 2016

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 Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01365234Model 20066 Left Ventricular (LV) Lead StudyPHASE1 COMPLETED 40Jul 1, 2011Dec 1, 2015Oct 12, 20164 Canada, Malaysia +1
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Study Endpoints
Primary Endpoints
Number of implant procedure related and lead-related complications in the first month post-implant
One Month
Secondary Endpoints
Success rate of the Model 20066 lead
Within 24 hours of procedure initiation
Cannulation time
Within 24 hours of procedure initiation
Fluoroscopy Time
Within 24 hours of procedure initiation
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
20066 LeadEXPERIMENTALNon-randomized study. Intervention: Device: Pacing Lead
Interventions
NameTypeDescription
Pacing LeadDEVICEImplant and follow up of Model 20066 lead
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Patient meets CRT inclusion criteria as determined by local regulatory and/or hospital policy * Patient has signed and dated the study-specific informed consent form * Patient is 18 years of age or older * Patient is expected to remain available for follow-ups at the investiga...

Countries:CanadaMalaysiaSweden
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