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

Heart Failure. Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01851889
• Other study ID #: H-3-2013-010
• Status: Completed
• Phase: N/A
• First received: April 29, 2013
• Last updated: October 26, 2015
• Start date: April 2013
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure.

Locations

Country	Name	City	State
Denmark	University Hospital Rigshospitalet.	Copenhagen	Kbh Oe

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary capillary wedge pressure in mmHg.		On trial day.	No