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Completed

NCT Number: NCT03001674

Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure

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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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conductance catheterization

Device

CD Leycom Conductance Catheter

Primary outcomes

  1. Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work.

    Time frame: 24 hours

    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.

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 23, 2016
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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