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EASYTRAK 3 left ventricular pacing lead

Phase 2

Congestive Heart Failure | Unknown | Cardiovascular |Boston Scientific Corporation|Last Updated: Jun 25, 2007

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment115

FDA Designations

No designations recorded

Clinical trial landscape

EASYTRAK 3 left ventricular pacing lead · 1 trial · 1 indication

Phase 2 1
NCT00158938Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense LeadCongestive Heart Failure
COMPLETED115 Analytics
PHASE2COMPLETED
Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead
Congestive Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

Pacing thresholds at 6 months
Pacing impedances at 6 months
R-wave amplitudes at 6 months
6-month complication free rate

Secondary Endpoints

left ventricular bipolar pacing and sensing with RENEWAL 3 H173 safety
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
EASYTRAK 3 left ventricular pacing leadDEVICE -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Moderate to severe heart failure (NYHA Class III/IV) including left ventricular dysfunction (EF \<= 35%) and QRS duration \>= 120 ms remaining symptomatic despite stable, optimal heart failure drug therapy. * Creatinine \< 2.5 mg/dL obtained no more than two weeks prior to enr...

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Frequently asked questions about EASYTRAK 3 left ventricular pacing lead

What is EASYTRAK 3 left ventricular pacing lead used for?

The EASYTRAK 3 left ventricular pacing lead is used for congestive heart failure. It is an investigational device being studied for this condition. The lead is designed for placement in the coronary venous system to deliver pacing to the left ventricle.

Who makes EASYTRAK 3 left ventricular pacing lead?

Boston Scientific Corporation (BSX) develops the EASYTRAK 3 left ventricular pacing lead. The company is conducting clinical research on this device for congestive heart failure.

What phase is EASYTRAK 3 left ventricular pacing lead in?

The EASYTRAK 3 left ventricular pacing lead is in Phase 2 clinical development. It is an investigational device and has not been approved by the FDA. One Phase 2 study has been completed.

What clinical trials is EASYTRAK 3 left ventricular pacing lead in?

The EASYTRAK 3 left ventricular pacing lead was studied in clinical trial NCT00158938, titled 'Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead'. This Phase 2 study enrolled 115 participants with congestive heart failure and has been completed.

Is EASYTRAK 3 left ventricular pacing lead the same as EASYTRAK 3?

Yes, EASYTRAK 3 left ventricular pacing lead is the same as EASYTRAK 3. The full name includes the description 'left ventricular pacing lead', while the clinical trial refers to it as the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead.