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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
  Purpose

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

Condition Intervention
Ischemic Congestive Cardiomyopathy
Dilated Cardiomyopathy
Congestive Heart Failure
 Procedure: Doppler flow measurement
Procedure: standard implantation of the LV lead

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Optimizing the Left Ventricular Contractility in Cardiac Resynchronization Therapy Using a Doppler Wire

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Main Line Health:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: December 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hemodynamicaly guided LV lead placement
optimized left ventricular lead placement
 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
Active Comparator: Standard lead placement
Standard LV lead placement with no measurements to guide LV lead placement
 Procedure: standard implantation of the LV lead
Standard implantation of the LV lead with measurements of flow

Detailed Description:

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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399801

Contacts
Contact: Dusan Kocovic, MD 610-649-6980 Kocovicd@mlhs.org
Contact: Nancy Britton, RN 484-476-8578 Brittonn@mlhs.org

Locations
United States, Pennsylvania
Lankenau Hosspital Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Dusan Kocovic, MD     610-649-6980     Kocovicd@mlhs.org    
Contact: Nancy Britton, RN     484-476-8578     Brittonn@mlhs.org    
Principal Investigator: Kocovic Dusan, MD            
Sponsors and Collaborators
Main Line Health
Investigators
Principal Investigator: Dusan Kocovic, MD Lankenau Hospital
  More Information

No publications provided

Responsible Party: Dusan Kocovic, M.D.,, Dusan Kocovic, MD, Main Line Health
ClinicalTrials.gov Identifier: NCT01399801     History of Changes
Other Study ID Numbers: F/N-R09-284IL
Study First Received: June 16, 2011
Last Updated: July 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Main Line Health:
Cardiac Resynchronization Therapy
medically refractory heart failure patients

Additional relevant MeSH terms:
Cardiomyopathy, Dilated
Heart Failure
Cardiomyopathies
 Cardiomegaly
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013