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OpenTrials
Completed

NCT Number: NCT00737490

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

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.

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Key information

Conditions

Cardiomyopathy Cardiomyopathies Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Other

Echocardiographically guided optimized device programming: specifically sequential BiV pacing. "Sequential Arm"

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

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

Other

simultaneous BiV pacing.

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Abbott Medical Devices

Registry information

Acronym: Devise-CRT

Important dates

Study start
2005
Primary completion
2009
Study completion
2011
First posted
Aug 19, 2008
Registry last updated
Aug 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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