Congestive Heart Failure, Dilated Cardiomyopathy, Ischemic Congestive Cardiomyopathy
Conditions
Keywords
Cardiac Resynchronization Therapy, medically refractory heart failure patients
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.
Interventions
PROCEDUREDoppler flow measurement
use of doppler wire to measure change in flow that corresponds to changes in stroke volume to guide LV lead placement
PROCEDUREstandard implantation of the LV lead
Standard implantation of the LV lead with measurements of flow
Sponsors
Main Line Health
Ann Marie Chikowski
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Increase in exercise capacity | 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 | six months | number of hospitalizations for CHF should decrease during follow up |
Countries
United States
Outcome results
None listed