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PCI, ILR implantation

Phase 2

Myocardial Infarction | Unknown | Cardiovascular |Rhythm Pharmaceuticals, Inc.|Last Updated: Jul 8, 2015

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
UNCONTROLLEDDMC
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02492243Continuous Rhythm Monitoring in Patients After Acute Myocardial infaRction andpREServed Lef venTricle Ejection Fraction (ARREST)PHASE2 COMPLETED 50Aug 1, 2011Jun 1, 2015Jul 8, 20151 Russia
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Study Endpoints
Primary Endpoints
Cardiac arrest
24 months
Sustained, nonsustained, symptomatic, asymptomatic ventricular tachycardias
24 months
Ventricular fibrillation
24 months
Atrial Fibrillation (symptomatic and asymptomatic)
24 months
Documented Arrhythmic death without evidence of primary non cardiac cause
24 months
Secondary Endpoints
All Arrhythmic events recorded by ILR
24 months
Changing in treatment strategy, based on physician decision
24 months
Invasive procedures for arrhythmia treatment
24 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTALPatients with documented myocardial infarction in the 7days prior to enrolment and left ventricular ejection fraction \>=40% as assessed by echocardiography within 7 days window after MI,who are not candidate to ICD/CRT/IPG implantation after PCI undergo ILR implantation
Interventions
NameTypeDescription
PCIDEVICE -
ILR implantationDEVICE -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria * Informed consent signed * Documented myocardial infarction in the 7days prior to enrolment * Age \> 18 yrs * Left ventricular ejection fraction \>=40% as assessed by echocardiography within 7 days window after MI. Exclusion Criteria * subject is unwilling or unable to comply ...

Countries:Russia
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