Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure

Heart Failure Clinical Trial

Official title:

Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03001674
• Other study ID #: IABP_Hemodynamics
• Status: Completed
• Phase: N/A
• First received: March 27, 2014
• Last updated: December 20, 2016
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2016
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Conductance catheterization
CD Leycom Conductance Catheter

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is the 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	No