Optimizing Continuous-flow Left Ventricular Assist Device Settings and Identification of Pump Malfunction - A Comparative Study of Echocardiography and Invasive Hemodynamics
Completed
- Conditions
- Heart Failure.
- Registration Number
- NCT01851889
- Lead Sponsor
- Rigshospitalet, Denmark
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pulmonary capillary wedge pressure in mmHg. On trial day.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Rigshospitalet.
🇩🇰Copenhagen, Kbh Oe, Denmark