Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure

Study Overview
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Brief Summary
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The primary objective of this study is to develop normative hemodynamic data (means and standard deviations) for the intra-aortic balloon pump (IABP) using pressure-volume loop and 3D-echocardiographic analyses.

Official Title
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Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Conductance catheterization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or females between 18-75 years of age NYHA Class III-IV heart failure at the time of MEGA deployment Stage C-D systolic heart failure Non-ischemic cardiomyopathy Preserved right ventricular function defined by 2D-echocardiography Clinically indicated left and right heart catheterization and MEGA-IABP placement Clinically indicated MEGA-IABP support for 12 hours minimum Exclusion Criteria: Ischemic cardiomyopathy Active myocardial ischemia or acute coronary syndrome Severe peripheral vascular disease Severe aortic or mitral valve insufficiency Severe aortic or mitral valve stenosis Right ventricular failure Inability to tolerate left and right heart catheterization Severe hemodynamic instability defined as a systolic BP <80mmHg despite vasopressor/inotropic support Sustained ventricular tachycardia (>10 beats) within 24 hours and/or ventricular fibrillation within 24 hours Pacemaker dependent rhythm Left ventricular thrombus Rapid atrial fibrillation (HR>120 bpm) Unable to provide informed consent Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IABP recipient<br>Referred for clinically indicated right heart catheterization with intervention of IABP placement prior to LVAD surgery. | Device: Conductance catheterization<br>* CD Leycom Conductance Catheter<br>|
| Experimental: Control<br>Control subjects undergoing left heart catheterization with an LV ejection fraction > 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled. | Device: Conductance catheterization<br>* CD Leycom Conductance Catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work. | We will be measuring left ventricular stroke work using a conductance catheter before and immediately after activation of an intra-aortic balloon pump (IABP). Left ventricular stroke work is quantified as the product of left ventricular pressure and volume. Conductance catheters are the primary method available for clinical measurement of left ventricular volume and pressure. | 24 hours |