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Cardiac Resynchronization Therapy

Phase 4

Heart Failure | Unknown | Cardiovascular |Medtronic plc.|Last Updated: Sep 20, 2012

Development status

Highest phase Phase 4 (NCT01238874)
Phase scored for MDTPhase 1
Registered trials 15 across 6 sponsors since Aug 2005

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

Cardiac Resynchronization Therapy · 1 trial · 1 indication

Early Phase 1 1
NCT01362465Characterization of Interventricular Conduction MeasurementsHeart Failure
COMPLETED25 Analytics
EARLY_PHASE1COMPLETED
Characterization of Interventricular Conduction Measurements
Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

Measure how RV to LV conduction times are altered by pacing site in patients with a CRT system.
30 minutes

This procedure will take approximately 30 minutes prior to implant of a CRT system. At completion of this study the patient is not followed and will be transferred to another study if enrolled in a clinical or followed as a routine implant by the center.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Cardiac Resynchronization Therapy (CRT)EXPERIMENTALImplanting device to measure delays between paced chambers in heart failure patients.

Interventions

NameTypeDescription
Cardiac Resynchronization TherapyPROCEDUREImplanting device to measure delays between paced chambers in heart failure patients.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patient is greater than 18 years of age. * The patient or the patient's legally authorized representative is willing to give informed consent. * CRT indicated guidelines. * Patient is receiving a Medtronic IPG or ICD. Exclusion Criteria: * Patients who are pregnant. * Patien...

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