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Single Site Pacing, Dual Site Pacing

Phase 2

Acute Myocardial Infarction | Unknown | Cardiovascular |Rhythm Pharmaceuticals, Inc.|Last Updated: Dec 15, 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
RandomizedDouble-BlindNO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment129
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01213251Post-Myocardial Infarction Remodeling Prevention TherapyPHASE2 COMPLETED 129 — — Dec 1, 2010Apr 1, 2016Dec 15, 201626 United States, Denmark +5
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Study Endpoints
Primary Endpoints
Change in Left Ventricular End Diastolic Volume (LVEDV)
Baseline - 18 Month Follow Up Visit

Left ventricular end diastolic volume (LVEDV) was measured by echocardiogram. Change was measured as Month 18 LVEDV minus baseline LVEDV. Per protocol, change in LVEDV is compared between Pooled Pacing (Single site + Dual Site) and Control.

Secondary Endpoints
Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events
18 months post-implant
Frequency of Hospitalization for Cardiovascular Events
Baseline - 18 Month Follow Up Visit
Change in New York Heart Association (NYHA) Functional Class
Baseline - 18 Month Follow Up Visit
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Single Site PacingEXPERIMENTAL -
Dual Site PacingEXPERIMENTAL -
ControlNO_INTERVENTION -
Interventions
NameTypeDescription
Single Site PacingDEVICESubjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
Dual Site PacingDEVICESubjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * Myocardial Infarction (MI) within the past 10 days * Peak Creatine Phosphokinase (CPK) greater than 3000 Units/Litre (U/L) at time of MI, or a troponin T (TnT) greater than 10 micrograms/Litre (mcg/L) * At least 18 years old * Willing to comply with the protocol Exclusion Cri...

Countries:United StatesDenmarkFranceGermanyHungarySaudi ArabiaSlovakia
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