Congestive Heart Failure Clinical Trial
— CARE/VOLCANOOfficial title:
Optimizing the Left Ventricular Contractility in Cardiac Resynchronization Therapy Using a Doppler Wire
Verified date | August 2022 |
Source | Main Line Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 12 |
Est. completion date | September 25, 2014 |
Est. primary completion date | September 25, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Lankenau Hosspital | Wynnewood | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Ann Marie Chikowski | Main Line Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Left Ventricular End Systolic Volume (LVESV) using the difference from baseline to six months | Comparison of clinical and functional outcomes of stroke volume optimized lead placement to standard lateral lead placement. | Six months | |
Secondary | Change in End diastolic volume | End diastolic volume should decrease over follow up time of six months as a result of left ventricular remodeling. | Six months | |
Secondary | Change in ejection fraction | Increase in ejection fraction should happen as a result of remodeling and increased efficiency of the left ventricle | six months | |
Secondary | Increase in exercise capacity | Inrease in exercise capacity should be result of remodeled left ventricle and increased stroke volume and cardiac output | six months | |
Secondary | Decrease in heart failure related hospital admissions | number of hospitalizations for CHF should decrease during follow up | six months |
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