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Cardiac Resynchronization Therapy

Phase 1

Heart Failure | Unknown | Cardiovascular |Rhythm Pharmaceuticals, Inc.|Last Updated: Sep 20, 2012

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 Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01362465Characterization of Interventricular Conduction MeasurementsEARLY_PHASE1 COMPLETED 25Jun 1, 2011Apr 1, 2012Sep 20, 2012 -
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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 — 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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