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pacemaker

Phase 3

Pacemaker Dependence | Unknown | Other |Medtronic plc.|Last Updated: Oct 19, 2007

Development status

Highest phase Phase 3
Registered trials 7 across 6 sponsors since Jan 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Clinical trial landscape

pacemaker · 1 trial · 1 indication

Phase 3 1
NCT00182416Second Canadian Trial of Physiologic Pacing (CTOPP II): Pilot TrialPacemaker Dependence
COMPLETED300 Analytics
PHASE3COMPLETED
Second Canadian Trial of Physiologic Pacing (CTOPP II): Pilot Trial
Pacemaker Dependence
NCT00182416300
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Study Endpoints

Primary Endpoints

Predictors of future pacemaker dependence
Feasibility of the trial
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
pacemakerDEVICE -
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Eligibility Criteria

Age Range66 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Patient has symptomatic bradycardia and is a candidate for first pacemaker implantation * Patient has high risk of being pacemaker dependent by (at least one of the following): 1. Average heart rate of 60 or less on pre-implant Holter 2. Maximal heart rate of 60 in patien...

Countries:Canada
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