Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure

Completed · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT03001674

Run by

Tufts Medical Center

People needed

15

Starts

2014-12-01

Expected to finish

2015-12-01

Last updated by the study team

2017-05-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Tufts Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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