Optimizing Left Ventricular Lead To Improve Cardiac Output
- Conditions
- Ischemic Congestive CardiomyopathyCongestive Heart FailureDilated Cardiomyopathy
- Interventions
- Procedure: standard implantation of the LV leadProcedure: Doppler flow measurement
- Registration Number
- NCT01399801
- Lead Sponsor
- Ann Marie Chikowski
- Brief Summary
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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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
- Previous implanted CRT-P/CRT-D
- woman who are pregnant
- Psychological or emotional problems
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard lead placement standard implantation of the LV lead Standard LV lead placement with no measurements to guide LV lead placement hemodynamicaly guided LV lead placement Doppler flow measurement optimized left ventricular lead placement
- Primary Outcome Measures
Name Time Method Change in Left Ventricular End Systolic Volume (LVESV) using the difference from baseline to six months Six months Comparison of clinical and functional outcomes of stroke volume optimized lead placement to standard lateral lead placement.
- Secondary Outcome Measures
Name Time Method Increase in exercise capacity six months Inrease in exercise capacity should be result of remodeled left ventricle and increased stroke volume and cardiac output
Change in End diastolic volume 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 six months Increase in ejection fraction should happen as a result of remodeling and increased efficiency of the left ventricle
Decrease in heart failure related hospital admissions six months number of hospitalizations for CHF should decrease during follow up
Trial Locations
- Locations (1)
Lankenau Hosspital
🇺🇸Wynnewood, Pennsylvania, United States