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Cardiac Resynchronization Therapy

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

Cardiac Resynchronization Therapy · 1 trial · 1 indication

Early Phase 1 1
NCT01362465Characterization of Interventricular Conduction MeasurementsHeart Failure
COMPLETED25 Analytics
EARLY_PHASE1COMPLETED
Characterization of Interventricular Conduction Measurements
Heart FailureUnlock trial analytics

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 to 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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Frequently asked questions about Cardiac Resynchronization Therapy

What is Cardiac Resynchronization Therapy used for in Heart Failure?

Cardiac Resynchronization Therapy is an investigational treatment being studied for heart failure. It is a non-randomized, uncontrolled early Phase 1 clinical study that has been completed. The therapy is being developed by Rhythm Pharmaceuticals, Inc. for patients with heart failure.

Who is developing Cardiac Resynchronization Therapy?

Rhythm Pharmaceuticals, Inc. (NASDAQ: RYTM) is developing Cardiac Resynchronization Therapy for heart failure. The company has conducted one clinical trial for this therapy, which has been completed. The trial enrolled 25 participants aged 18 years and older.

What phase is Cardiac Resynchronization Therapy in?

Cardiac Resynchronization Therapy is in early Phase 1 clinical development for heart failure. The therapy is investigational and not yet approved. One early Phase 1 trial has been completed, with no active trials currently ongoing.

What clinical trials has Cardiac Resynchronization Therapy been in?

Cardiac Resynchronization Therapy has been studied in one completed clinical trial, NCT01362465, titled "Characterization of Interventricular Conduction Measurements." This early Phase 1 trial enrolled 25 participants with heart failure and was not randomized or blinded.

Is Cardiac Resynchronization Therapy FDA approved?

Cardiac Resynchronization Therapy is not FDA approved. It is an investigational therapy in early Phase 1 clinical development for heart failure. The completed trial, NCT01362465, was an uncontrolled study that has finished, but the therapy remains in clinical development.