Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure

NCT03001674 | Completed Results

• 1 other identifier: IABP_Hemodynamics
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (2)

IABP recipient

EXPERIMENTAL

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

Device: Conductance catheterization

Control

EXPERIMENTAL

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

Interventions

Conductance catheterization DEVICE

CD Leycom Conductance Catheter

Control; IABP recipient

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

Small number of patients studied. Non-randomized study.

Results Point of Contact

• Title: Dr. Navin Kapur
• Organization: Tufts Medical Center

nkapur@tuftsmedicalcenter.org

617 636 0720

Study Officials

• Navin Kapur, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: December 23, 2016
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 31, 2017
• Results First Posted: May 31, 2017

Record last verified: 2017-04

Locations

US (1)