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

Rigshospitalet

Status: Completed

Conditions: Heart Failure.

Study type: Observational

Funder types: Other

Identifiers

NCT01851889

H-3-2013-010

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

15 participants in 1 patient group

CF-LVAD pump speed.