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Optimizing Left Ventricular Lead To Improve Cardiac Output (CARE/VOLCANO)

This study is currently recruiting participants.
Verified July 2012 by Main Line Health
Sponsor:
Information provided by (Responsible Party):
Dusan Kocovic, M.D.,, Main Line Health
ClinicalTrials.gov Identifier:
NCT01399801
First received: June 16, 2011
Last updated: July 17, 2012
Last verified: July 2012
History of Changes

June 16, 2011
July 17, 2012
December 2010
December 2012   (final data collection date for primary outcome measure)
Change in Left Ventricular End Systolic Volume (LVESV) using the difference from baseline to six months [ Time Frame: Six months ] [ Designated as safety issue: No ]
Comparison of clinical and functional outcomes of stroke volume optimized lead placement to standard lateral lead placement.
Same as current
Complete list of historical versions of study NCT01399801 on ClinicalTrials.gov Archive Site
  • Change in End diastolic volume [ Time Frame: Six months ] [ Designated as safety issue: No ]
    End diastolic volume should decrease over follow up time of six months as a result of left ventricular remodeling.
  • Change in ejection fraction [ Time Frame: six months ] [ Designated as safety issue: No ]
    Increase in ejection fraction should happen as a result of remodeling and increased efficiency of the left ventricle
  • Increase in exercise capacity [ Time Frame: six months ] [ Designated as safety issue: No ]
    Inrease in exercise capacity should be result of remodeled left ventricle and increased stroke volume and cardiac output
  • Decrease in heart failure related hospital admissions [ Time Frame: six months ] [ Designated as safety issue: No ]
    number of hospitalizations for CHF should decrease during follow up
Same as current
Not Provided
Not Provided
 
Optimizing Left Ventricular Lead To Improve Cardiac Output
Optimizing the Left Ventricular Contractility in Cardiac Resynchronization Therapy Using a Doppler Wire

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

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:

  1. 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.
  2. 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.
  3. Acutely contrast changes in stroke volume during pacing from several different left ventricular lead locations.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Ischemic Congestive Cardiomyopathy
  • Dilated Cardiomyopathy
  • Congestive Heart Failure
  • Procedure: Doppler flow measurement
    use of doppler wire to measure change in flow that corresponds to changes in stroke volume to guide LV lead placement
  • Procedure: standard implantation of the LV lead
    Standard implantation of the LV lead with measurements of flow
  • Experimental: hemodynamicaly guided LV lead placement
    optimized left ventricular lead placement
    Intervention: Procedure: Doppler flow measurement
  • Active Comparator: Standard lead placement
    Standard LV lead placement with no measurements to guide LV lead placement
    Intervention: Procedure: standard implantation of the LV lead
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
June 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Dusan Kocovic, MD 610-649-6980 Kocovicd@mlhs.org
Contact: Nancy Britton, RN 484-476-8578 Brittonn@mlhs.org
United States
 
NCT01399801
F/N-R09-284IL
Yes
Dusan Kocovic, M.D.,, Main Line Health
Main Line Health
Not Provided
Principal Investigator: Dusan Kocovic, MD Lankenau Hospital
Main Line Health
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP