Optimizing Continuous-flow Left Ventricular Assist Device... | NCT01851889

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Oct 2015Actual

First Submitted Date

Apr 29, 2013

First Submission Date that Met QC Criteria

May 10, 2013

First Posted Date

May 13, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2015

Last Update Posted Date

Oct 28, 2015Estimated

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Label	Type	Description	Intervention Names
CF-LVAD pump speed.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All heart failure patients with CF-LVAD at University Hospital of Copenhagen, Rigshospitalet.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mette H Jung, MD	Department of Cardiology B, University Hospital Rigshospitalet.	Principal Investigator
Finn Gustafsson, MD, DMSc, PhD	Department of Cardiology B, University Hospital Rigshospitalet.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Rigshospitalet.		Copenhagen	Kbh Oe	2100	Denmark

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases