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Does Echocardiographically Guided Ventriculo-Ventricular Optimization Yield a Sustained Improvement in Echocardiographic Parameters in Cardiac Resynchronization Therapy Patients? (DEVISE CRT)

NCT00737490 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-08-01

No results posted yet for this study

Summary

The purpose of this study is to determine whether using an echocardiogram (a painless test where ultrasound is used to see your heart) while using mild electrical stimulation from your own CRT-D device to stimulate the ventricles (the lower chambers of the heart) to squeeze one slightly earlier than the other will show a sustained increase your heart's productivity (Cardiac Output (CO)), following implantation of a Cardiac Resynchronization Device (CRT-D). We believe that squeezing some parts of the heart earlier than others may make the heart a stronger pump.

Conditions

Interventions

OTHER

"Sequential Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343)

Echocardiographically guided optimized device programming: specifically sequential BiV pacing. "Sequential Arm" Using one of the FDA approved St. Jude devices, depending on MD preference.

OTHER

"Simultaneous Arm" (Promote , model # 2207-36 or Atlas HF , model # V-343)

simultaneous BiV pacing. Using one of the FDA approved St. Jude devices, depending on MD preference.

Sponsors & Collaborators

Principal Investigators

  • Hranitzky Patrick, MD · Duke University

  • Patrick Hranitzky, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2009-12-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00737490 on ClinicalTrials.gov