Optimizing Continuous-flow Left Ventricular Assist Device Settings and Identification of Pump Malfunction - A Comparative Study of Echocardiography and Invasive Hemodynamics

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01851889

Enrollment

Registered

2013-05-13

Start date

2013-04-30

Completion date

2015-10-31

Last updated

2015-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure.

Brief summary

The purpose of the trial is to identify factors which can be used as guidance when optimizing continuous-flow left ventricular assist device (CF-LVAD) settings. The hypothesis of the study is that pulmonary capillary wedge pressure (PCWP) will change independently of left ventricular end diastolic diameter (LVEDD) when increasing pump speed ie ΔPCWP/RPM ≠ ΔLVEDD/RPM. The primary combined endpoint of the study is correlation between ΔPCWP and LVEDD slope under ramp testing in a cohort of continuous-flow left ventricular assist device heart failure patients.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Heart failure patients with HeartMate II (HM II) followed as outpatients at The Heart Centre at University Hospital of Copenhagen, Rigshospitalet. * Age \> 18 years. * Heart failure in stable phase without the need for intravenous inotropic therapy. * Ischemic or non-ischemic cardiomyopathy. * Signed informed consent.

Exclusion criteria

* Unstable patients with the need for intravenous inotropic therapy. * Current hospitalization. * Implantation of HM II less than one month ago.

Design outcomes

Primary

Measure	Time frame
Pulmonary capillary wedge pressure in mmHg.	On trial day.

Countries

Denmark

Outcome results