Heart Failure Clinical Trial

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Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure

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Summary

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.

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Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

15

Study ID:

NCT03001674

Recruitment Status:

Completed

Sponsor:

Tufts Medical Center

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There is 1 Location for this study

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Tufts Medical Center
Boston Massachusetts, 02111, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

15

Study ID:

NCT03001674

Recruitment Status:

Completed

Sponsor:


Tufts Medical Center

How clear is this clinincal trial information?

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