Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure

Tufts University

Status: Completed

Conditions: Heart Failure

Treatments: Device: Conductance catheterization

Study type: Interventional

Funder types: Other

Identifiers

NCT03001674

IABP_Hemodynamics

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

IABP recipient

Experimental group

Description:

Referred for clinically indicated right heart catheterization with intervention of IABP placement prior to LVAD surgery.

Treatment:

Device: Conductance catheterization

Control

Experimental group

Description:

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.

Treatment:

Device: Conductance catheterization