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CONTAK RENEWAL 2/4/4HE CRT-D, EASYTRAK 2 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

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment360

FDA Designations

No designations recorded

Clinical trial landscape

CONTAK RENEWAL 2/4/4HE CRT-D, EASYTRAK 2 Lead · 1 trial · 1 indication

Phase 2 1
NCT00158951Device Evaluation of Contak Renewal 2and Easytrak 2 - DECREASE-HFCongestive Heart Failure
COMPLETED360 Analytics
PHASE2COMPLETED
Device Evaluation of Contak Renewal 2and Easytrak 2 - DECREASE-HF
Congestive Heart Failure
NCT00158951360
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Study Endpoints

Primary Endpoints

Therapy Efficacy: Change in cardiac function at six-months
Therapy Safety: CRT does not increase HF related adverse events at six-months
Device Efficacy; Therapy does not affect ability to detect VF, Stable chronic LV thresholds, R-wave amplitudes and impedances
Device Safety: System complication free rate at six-months, Lead related complication free rate at six-months

Secondary Endpoints

Therapy Efficacy: Change in cardiac function and reduced HF symptoms
Therapy Safety: Continuous appropriate pacing
Device Efficacy: Stable chronic LV thresholds, R-wave amplitudes and impedances from those not selected in final programming at six-months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
CONTAK RENEWAL 2/4/4HE CRT-DDEVICE -
EASYTRAK 2 LeadDEVICE -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Meet the general indications for a CRT-D device * Moderate or severe heart failure, defined as NYHA Class III-IV despite optimal pharmacological heart failure therapy. * A 12-lead electrocardiogram (ECG) obtained no more than 90 days prior to enrollment documenting a sinus rat...

Countries:United States
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Frequently asked questions about CONTAK RENEWAL 2/4/4HE CRT-D, EASYTRAK 2 Lead

What is CONTAK RENEWAL 2/4/4HE CRT-D, EASYTRAK 2 Lead used for?

CONTAK RENEWAL 2/4/4HE CRT-D, EASYTRAK 2 Lead is used for congestive heart failure. It is a cardiac resynchronization therapy device with a defibrillator (CRT-D) and a lead system designed to coordinate heart contractions in patients with heart failure.

Who makes CONTAK RENEWAL 2/4/4HE CRT-D, EASYTRAK 2 Lead?

Boston Scientific Corporation (NYSE: BSX) develops CONTAK RENEWAL 2/4/4HE CRT-D, EASYTRAK 2 Lead. The company is a medical device manufacturer focused on cardiovascular and other therapeutic areas.

What phase is CONTAK RENEWAL 2/4/4HE CRT-D, EASYTRAK 2 Lead in?

CONTAK RENEWAL 2/4/4HE CRT-D, EASYTRAK 2 Lead is in Phase 2 clinical development. It is an investigational device and has not been approved by the FDA based on the available clinical trial data.

What clinical trials is CONTAK RENEWAL 2/4/4HE CRT-D, EASYTRAK 2 Lead in?

CONTAK RENEWAL 2/4/4HE CRT-D, EASYTRAK 2 Lead was evaluated in the DECREASE-HF trial (NCT00158951), a Phase 2, randomized, double-blind study in the United States. The trial enrolled 360 participants with congestive heart failure and has been completed.

Is CONTAK RENEWAL 2/4/4HE CRT-D, EASYTRAK 2 Lead the same as EASYTRAK 2?

CONTAK RENEWAL 2/4/4HE CRT-D, EASYTRAK 2 Lead refers to a combination of the CONTAK RENEWAL 2/4/4HE CRT-D device and the EASYTRAK 2 lead. The EASYTRAK 2 is the lead component used with the CRT-D device.