- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04263012
Establishment of a LVAD Destination Program in a Swiss Non Cardiac Transplant University Hospital
February 18, 2020 updated by: University Hospital, Basel, Switzerland
Establishment of a LVAD Destination Program in a Swiss Non Cardiac Transplant University Hospital: 5 Year Experience
The goal of this study is to demonstrate the challenges and the effort to set up an artificial heart program as well as to report about the follow-up treatment and the mortality rate
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Basel, Switzerland, 4031
- Herzchirurgie University Hospital Basel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients who received an LVAD implant
Description
Inclusion Criteria:
- Patients who received an LVAD implant
Exclusion Criteria:
- not enough data collected
- stated will of the Patient, that his data can not be used
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with an implanted LVAD
Patients which received an implantation of a left ventricular assist device (LVAD) at the University Hospital Basel since 2014
|
assess mortality rate, rehospitalization and survival rate of patients after receiving an artificial heart implant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30 days mortality
Time Frame: 30 days after surgery
|
mortality rate 30 days after receiving the LVAD implant
|
30 days after surgery
|
rehospitalization rate
Time Frame: between day of surgery and 31.12.2019
|
rehospitalization rate of patients after receiving the LVAD implant
|
between day of surgery and 31.12.2019
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
survival rate
Time Frame: between day of surgery and 31.12.2019
|
survival rate of patients after receiving the LVAD implant (Kaplan-Meier curve)
|
between day of surgery and 31.12.2019
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Martin Grapow, Prof Dr. med., Herzzentrum Hirslanden Zürich
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2019
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
February 6, 2020
First Submitted That Met QC Criteria
February 6, 2020
First Posted (Actual)
February 10, 2020
Study Record Updates
Last Update Posted (Actual)
February 20, 2020
Last Update Submitted That Met QC Criteria
February 18, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 2020-00017; ch19Grapow2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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