Lankenau Hosspital
Wynnewood, Pennsylvania, 19096, United States
NCT Number: NCT01399801
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
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Interventional
Not applicable
Wynnewood, Pennsylvania, 19096, United States
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
use of doppler wire to measure change in flow that corresponds to changes in stroke volume to guide LV lead placement
Standard implantation of the LV lead with measurements of flow
Time frame: Six months
Comparison of clinical and functional outcomes of stroke volume optimized lead placement to standard lateral lead placement.
Time frame: Six months
End diastolic volume should decrease over follow up time of six months as a result of left ventricular remodeling.
Time frame: six months
Increase in ejection fraction should happen as a result of remodeling and increased efficiency of the left ventricle
Time frame: six months
Inrease in exercise capacity should be result of remodeled left ventricle and increased stroke volume and cardiac output
Time frame: six months
number of hospitalizations for CHF should decrease during follow up
Ann Marie Chikowski
Other
Optimizing the Left Ventricular Contractility in Cardiac Resynchronization Therapy Using a Doppler Wire
Acronym: CARE/VOLCANO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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