Heart Failure
Conditions
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.
Interventions
DEVICEConductance catheterization
CD Leycom Conductance Catheter
Sponsors
Tufts Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work. | 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. |
Countries
United States
Participant flow
Recruitment details
10 patients with advanced HF from 2014 to 2015 at Tufts Medical Center referred for clinically indicated RHC and IABP placement prior to LVAD surgery. Five 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.
Participants by arm
| Arm | Count |
|---|---|
| IABP Recipient Conductance catheterization: CD Leycom Conductance Catheter | 10 |
| Control Conductance catheterization: CD Leycom Conductance Catheter | 5 |
| Total | 15 |
Baseline characteristics
| Characteristic | IABP Recipient | Control | Total |
|---|---|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 14 | 54 years STANDARD_DEVIATION 13 | 56 years STANDARD_DEVIATION 13 |
| Body Surface Area (BSA) | 2.07 m^2 STANDARD_DEVIATION 0.33 | 2.22 m^2 STANDARD_DEVIATION 0.15 | 2.12 m^2 STANDARD_DEVIATION 0.28 |
| Region of Enrollment United States | 10 participants | 5 participants | 15 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 8 Participants | 3 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 5 |
| other Total, other adverse events | 0 / 10 | 0 / 5 |
| serious Total, serious adverse events | 0 / 10 | 0 / 5 |
Outcome results
Primary
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.
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IABP Recipient | Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work. | Stroke work without IABP | 939 mmHg-mL | Standard Deviation 302 |
| IABP Recipient | Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work. | Stroke work with IABP | 667 mmHg-mL | Standard Deviation 210 |
| Control | Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work. | Stroke work without IABP | 5628 mmHg-mL | Standard Deviation 2866 |
| Control | Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work. | Stroke work with IABP | NA mmHg-mL | — |