Optimizing Left Ventricular Lead To Improve Cardiac Output (CARE/VOLCANO)
Recruitment status was: Recruiting
The purpose of this study is to determine if optimal lead placement, guided by the largest improvement in aortic flow measured by Doppler will:
- Improve the way the heart's left ventricle functions
- Decrease the number of hospital admissions for heart failure related symptoms
- Reduces uncoordinated heart contractions
- Improve quality of life as measured by the Minnesota Living with Heart Failure Questionaire and NYHA Class assessed after six months
|Ischemic Congestive Cardiomyopathy Dilated Cardiomyopathy Congestive Heart Failure||Procedure: Doppler flow measurement Procedure: standard implantation of the LV lead|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
|Official Title:||Optimizing the Left Ventricular Contractility in Cardiac Resynchronization Therapy Using a Doppler Wire|
- 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.
- 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.
- 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
- 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
- Decrease in heart failure related hospital admissions [ Time Frame: six months ]number of hospitalizations for CHF should decrease during follow up
|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)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399801
|Contact: Dusan Kocovic, MD||610-649-6980||Kocovicd@mlhs.org|
|Contact: Nancy Britton, RN||484-476-8578||Brittonn@mlhs.org|
|United States, Pennsylvania|
|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|
|Principal Investigator:||Dusan Kocovic, MD||Lankenau Hospital|