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

July 31, 2014 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. LVEF </= 35% as assessed by echocardiography.
  2. New York Heart Association Functional Class III or IV CHF despite contemporary medical therapy for CHF.
  3. QRS duration of >/= 120 ms.
  4. Ability to provide written, informed consent.
  5. Age > 18 years.
  6. Successful implant of a biventricular/ICD pacemaker device.

Exclusion Criteria:

  1. Documented Chronic Atrial Fibrillation
  2. Life expectancy less that 6 months due to non-cardiac causes
  3. Inability to place a coronary sinus left ventricular pacing lead
  4. Pregnancy
  5. Scheduled cardiac surgery within the next 6 months
  6. Prosthetic Tricuspid Valve

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Echocardiographically guided optimized device programming: specifically sequential BiV pacing. "Sequential Arm"
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.
Active Comparator: 2
Simultaneous BiV pacing. "Simultaneous Arm"
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine if a sustained hemodynamic benefit of increased Cardiac Output is maintained in patients who undergo ECHO guided optimization of V-V timing following CRT implantation when compared to patients simultaneously biventricularly paced.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment for improvements in 1)6 minute walk 2)ECHO parameters 3)symptoms as assessed by the Minnesota Quality of Life Score.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Abbott Medical Devices

Investigators

  • Principal Investigator: Hranitzky Patrick, MD, Duke University
  • Study Director: Patrick Hranitzky, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

May 4, 2008

First Submitted That Met QC Criteria

August 18, 2008

First Posted (Estimate)

August 19, 2008

Study Record Updates

Last Update Posted (Estimate)

August 1, 2014

Last Update Submitted That Met QC Criteria

July 31, 2014

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00007865
  • 7314 (CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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