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Device Evaluation of Contak Renewal 2and Easytrak 2 - DECREASE-HF

NCT00158951 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2007-06-25

No results posted yet for this study

Summary

The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the CONTAK® RENEWAL™ 2/4/4HE cardiac resynchronization therapy defibrillator (CRT-D) family and EASYTRAK® 2 lead in delivering LV-CRT or BiV-CRT with an LV Offset for patients with heart failure and an indication for an ICD.

Conditions

  • Congestive Heart Failure

Interventions

DEVICE

CONTAK RENEWAL 2/4/4HE CRT-D

DEVICE

EASYTRAK 2 Lead

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Completion
2004-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00158951 on ClinicalTrials.gov