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OpenTrials
Completed

NCT Number: NCT01399801

Optimizing Left Ventricular Lead To Improve Cardiac Output

The purpose of this study is to determine if optimal lead placement, guided by the largest improvement in aortic flow measured by Doppler will:

1. Improve the way the heart's left ventricle functions 2. Decrease the number of hospital admissions for heart failure related symptoms 3. Reduces uncoordinated heart contractions 4. Improve quality of life as measured by the Minnesota Living with Heart Failure Questionaire and NYHA Class assessed after six months

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Key information

About this study

The hypothesis of this study determines if response to CRT therapy could be improved by optimizing LV lead position at the time of the left ventricular pacing lead implantation. This optimization (using a Doppler wire) would alter the left ventricular activation pattern and contraction mechanics. This increase in contractility may improve the likelihood of mid/long term response to therapy. This study will compare 6-month response to CRT (left ventricular ejection fraction, decrease in left ventricular end systolic and end diastolic dimensions and volumes) in heart failure patients.

The secondary objective will be to:

  • To determine if optimal lead placement, guided by the largest improvement in stroke volume, results in a greater 6-month improvement in clinical QOL and NYHA class.
  • Acutely compare and/or correlate intra-operative A-V and V-V timing optimization via invasive pressure volume data to post-operative echo optimization of these same parameters.
  • Acutely contrast changes in stroke volume during pacing from several different left ventricular lead locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical indication for CRT-P or CRT-D
  • QRS Duration>=120 MSEC
  • Left Ventricular Ejection fraction<=35%
  • NYHA Class III-IV
  • History of Cardiomyopathy, least one month post MI, or at least six months old in case of non-ischemic cardiomyopathy
  • At least 18 years of afe

Exclusion criteria

  • Previous implanted CRT-P/CRT-D
  • woman who are pregnant
  • Psychological or emotional problems

Treatment and study plan

Doppler flow measurement

Procedure

use of doppler wire to measure change in flow that corresponds to changes in stroke volume to guide LV lead placement

standard implantation of the LV lead

Procedure

Standard implantation of the LV lead with measurements of flow

Primary outcomes

  1. Change in Left Ventricular End Systolic Volume (LVESV) using the difference from baseline to six months

    Time frame: Six months

    Comparison of clinical and functional outcomes of stroke volume optimized lead placement to standard lateral lead placement.

Secondary outcomes

  1. Change in End diastolic volume

    Time frame: Six months

    End diastolic volume should decrease over follow up time of six months as a result of left ventricular remodeling.

  2. Change in ejection fraction

    Time frame: six months

    Increase in ejection fraction should happen as a result of remodeling and increased efficiency of the left ventricle

  3. Increase in exercise capacity

    Time frame: six months

    Inrease in exercise capacity should be result of remodeled left ventricle and increased stroke volume and cardiac output

  4. Decrease in heart failure related hospital admissions

    Time frame: six months

    number of hospitalizations for CHF should decrease during follow up

Sponsors and collaborators

Lead sponsor

Ann Marie Chikowski

Other

Collaborators

  • Main Line Health

Registry information

Official study title

Optimizing the Left Ventricular Contractility in Cardiac Resynchronization Therapy Using a Doppler Wire

Acronym: CARE/VOLCANO

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 22, 2011
Registry last updated
Aug 30, 2022

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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