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PCI, ILR implantation

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

PCI, ILR implantation · 1 trial · 1 indication

Phase 2 1
NCT02492243Continuous Rhythm Monitoring in Patients After Acute Myocardial infaRction andpREServed Lef venTricle Ejection Fraction (ARREST)Myocardial Infarction
COMPLETED50 Analytics
PHASE2COMPLETED
Continuous Rhythm Monitoring in Patients After Acute Myocardial infaRction andpREServed Lef venTricle Ejection Fraction (ARREST)
Myocardial Infarction
NCT0249224350
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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 to 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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Frequently asked questions about PCI, ILR implantation

What is PCI, ILR implantation used for in Myocardial Infarction?

PCI, ILR implantation is used for continuous rhythm monitoring in patients after acute myocardial infarction with preserved left ventricle ejection fraction. It involves implanting an implantable loop recorder to track heart rhythms. The therapy is being studied as a Phase 2 investigational approach for this cardiovascular condition.

Who makes PCI, ILR implantation?

Rhythm Pharmaceuticals, Inc. (NASDAQ: RYTM) is developing PCI, ILR implantation. The company is conducting clinical research on this device-based approach for monitoring patients after myocardial infarction.

What phase is PCI, ILR implantation in?

PCI, ILR implantation is in Phase 2 clinical development. It is an investigational approach and has not been approved by regulatory authorities. The therapy is being evaluated for use in patients who have experienced a myocardial infarction.

What clinical trials is PCI, ILR implantation in?

PCI, ILR implantation is associated with one completed clinical trial, NCT02492243, titled "Continuous Rhythm Monitoring in Patients After Acute Myocardial infaRction andpREServed Lef venTricle Ejection Fraction (ARREST)". This Phase 2 study enrolled 50 participants in Russia and has been completed.

Is PCI, ILR implantation the same as ARREST?

No, PCI, ILR implantation is not the same as ARREST. ARREST is the name of the clinical trial (NCT02492243) evaluating PCI, ILR implantation. The trial is titled "Continuous Rhythm Monitoring in Patients After Acute Myocardial infaRction andpREServed Lef venTricle Ejection Fraction (ARREST)".