NCT04263012

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

1 month

First QC Date

February 6, 2020

Last Update Submit

February 18, 2020

Conditions

Heart Implant Complication

Keywords

left ventricular assist device (LVAD)heartimplantartificial

Outcome Measures

Primary Outcomes (2)

  • 30 days mortality

    mortality rate 30 days after receiving the LVAD implant

    30 days after surgery

  • rehospitalization rate

    rehospitalization rate of patients after receiving the LVAD implant

    between day of surgery and 31.12.2019

Secondary Outcomes (1)

  • survival rate

    between day of surgery and 31.12.2019

Study Arms (1)

Patients with an implanted LVAD

Patients which received an implantation of a left ventricular assist device (LVAD) at the University Hospital Basel since 2014

Other: collection of patient data

Interventions

collection of patient dataOTHER

assess mortality rate, rehospitalization and survival rate of patients after receiving an artificial heart implant

Patients with an implanted LVAD

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who received an LVAD implant

You may qualify if:

  • Patients who received an LVAD implant

You may not qualify if:

  • not enough data collected
  • stated will of the Patient, that his data can not be used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herzchirurgie University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

  • Schaeffer T, Pfister O, Mork C, Mohacsi P, Rueter F, Scheifele S, Morgen A, Zenklusen U, Doebele T, Maurer M, Erb J, Fassl J, Cueni N, Siegemund M, Pargger H, Gahl B, Osswald S, Eckstein F, Grapow M. 5-year results of a newly implemented mechanical circulatory support program for terminal heart failure patients in a Swiss non-cardiac transplant university hospital. J Cardiothorac Surg. 2021 Mar 31;16(1):64. doi: 10.1186/s13019-021-01447-5.

    PMID: 33789723DERIVED

Study Officials

  • Martin Grapow, Prof Dr. med.

    Herzzentrum Hirslanden Zürich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 10, 2020

Study Start

December 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations

CH(1)