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hemodynamicaly guided LV lead placement for Dilated Cardiomyopathy (CARE/VOLCANO Trial)
N/A
Waitlist Available
Led By Dusan Kocovic, MD
Research Sponsored by Ann Marie Chikowski
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months
Awards & highlights
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
Eligible Conditions
- Dilated Cardiomyopathy
- Congestive Heart Failure
- Congestive Cardiomyopathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Left Ventricular End Systolic Volume (LVESV) using the difference from baseline to six months
Secondary study objectives
Change in End diastolic volume
Change in ejection fraction
Decrease in heart failure related hospital admissions
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: hemodynamicaly guided LV lead placementExperimental Treatment1 Intervention
optimized left ventricular lead placement
Group II: Standard lead placementActive Control1 Intervention
Standard LV lead placement with no measurements to guide LV lead placement
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doppler flow measurement
2010
N/A
~20
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Who is running the clinical trial?
Ann Marie ChikowskiLead Sponsor
Main Line HealthOTHER
21 Previous Clinical Trials
6,877 Total Patients Enrolled
Dusan Kocovic, MDPrincipal InvestigatorLankenau Hospital
1 Previous Clinical Trials
486 Total Patients Enrolled
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