Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
N/A N=15 Diagnostic

Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT03001674 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work. — 939; 5628; 667; NA mmHg-mL

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Conductance catheterization (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Tufts Medical Center
Primary completion
Dec 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work.		 939; 5628; 667; NA —

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.

Eligibility Criteria

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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03001674). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search