Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure

April 25, 2017 updated by: Tufts Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IABP recipient
Referred for clinically indicated right heart catheterization with intervention of IABP placement prior to LVAD surgery.
Device: Conductance catheterization
CD Leycom Conductance Catheter
Experimental: Control
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
CD Leycom Conductance Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Investigators

  • Principal Investigator: Navin Kapur, MD, Tufts Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

December 20, 2016

First Posted (Estimate)

December 23, 2016

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IABP_Hemodynamics

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Conductance catheterization

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe