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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindNO_TREATMENT_CONTROLLEDDMC
Total Trials1
Total Enrollment129

FDA Designations

No designations recorded

Clinical trial landscape

Single Site Pacing, Dual Site Pacing · 1 trial · 4 indications

Phase 2 1
NCT01213251Post-Myocardial Infarction Remodeling Prevention TherapyAcute Myocardial Infarction
COMPLETED129 Analytics
PHASE2COMPLETED
Post-Myocardial Infarction Remodeling Prevention Therapy
Acute Myocardial InfarctionUnlock trial analytics

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 to 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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Frequently asked questions about Single Site Pacing, Dual Site Pacing

What is Single Site Pacing, Dual Site Pacing used for?

Single Site Pacing, Dual Site Pacing is an investigational pacing therapy being studied for use in Acute Myocardial Infarction. It is intended to address cardiac remodeling and heart failure following a heart attack. The therapy is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Single Site Pacing, Dual Site Pacing?

Single Site Pacing, Dual Site Pacing is being developed by Rhythm Pharmaceuticals, Inc., a company traded on the NASDAQ under the ticker symbol RYTM. The company is conducting clinical research to evaluate this pacing therapy for patients with Acute Myocardial Infarction.

What phase is Single Site Pacing, Dual Site Pacing in?

Single Site Pacing, Dual Site Pacing is in Phase 2 clinical development. It is an investigational therapy, meaning it has not yet been approved for commercial use. The therapy is being studied for its potential to prevent cardiac remodeling and heart failure in patients who have experienced an Acute Myocardial Infarction.

What clinical trials is Single Site Pacing, Dual Site Pacing in?

Single Site Pacing, Dual Site Pacing has been studied in one completed clinical trial, identified as NCT01213251. This Phase 2 trial, titled 'Post-Myocardial Infarction Remodeling Prevention Therapy,' enrolled 129 participants across multiple countries including the United States, Denmark, France, Germany, Hungary, Saudi Arabia, and Slovakia.

Is Single Site Pacing, Dual Site Pacing the same as pacing therapy for heart failure?

Single Site Pacing, Dual Site Pacing is a specific investigational pacing approach being studied for Acute Myocardial Infarction. While it is related to pacing therapy concepts, it is distinct in its focus on preventing cardiac remodeling and heart failure after a heart attack. The therapy is still in clinical trials and not yet established as a standard treatment.