Heart Implant ComplicationNCT04263012
Establishment of a LVAD Destination Program in a Swiss Non Cardiac Transplant University Hospital
An observational study of Heart Implant Complication, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Implant Complication
- What is being tested?
- collection of patient data
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients who received an LVAD implant
Who may be able to join
- Patients who received an LVAD implant
Who cannot join
- not enough data collected
- stated will of the Patient, that his data can not be used
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Heart Implant Complication
- Being tested
- collection of patient data
- Keywords
- left ventricular assist device (LVAD), heart, implant, artificial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of patient dataOther
assess mortality rate, rehospitalization and survival rate of patients after receiving an artificial heart implant
| Study group | Role | What they receive |
|---|---|---|
| Patients with an implanted LVAD | Patients which received an implantation of a left ventricular assist device (LVAD) at the University Hospital Basel since 2014 Receives: Other: collection of patient data |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 days mortality
mortality rate 30 days after receiving the LVAD implant
Measured: 30 days after surgery
rehospitalization rate
rehospitalization rate of patients after receiving the LVAD implant
Measured: between day of surgery and 31.12.2019
Secondary outcomes (1)
survival rate
survival rate of patients after receiving the LVAD implant (Kaplan-Meier curve)
Measured: between day of surgery and 31.12.2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start1 Dec 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Implant ComplicationStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Grapow, Prof Dr. med., Principal investigator, HerzZentrum Hirslanden Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263012
- Sponsor's protocol ID
- 2020-00017; ch19Grapow2
- Status last verified
- Feb 2020
- First submitted
- 6 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33789723
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a LVAD Destination Program in a Swiss Non Cardiac Transplant University Hospital: 5 Year Experience
- ClinicalTrials.gov ID
- NCT04263012
- Acronym / sponsor ID
- 2020-00017; ch19Grapow2
- Conditions
- Heart Implant Complication
- Keywords
- left ventricular assist device (LVAD), heart, implant, artificial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with an implanted LVAD | – | Other: collection of patient dataPatients which received an implantation of a left ventricular assist device (LVAD) at the University Hospital Basel since 2014 |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who received an LVAD implant
Key inclusion criteria (1 listed)
- Patients who received an LVAD implant
Key exclusion criteria (2 listed)
- not enough data collected
- stated will of the Patient, that his data can not be used
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of patient dataassess mortality rate, rehospitalization and survival rate of patients after receiving an artificial heart implant | Other | Patients with an implanted LVAD |
Primary outcome
30 days mortality
Time frame: 30 days after surgery
mortality rate 30 days after receiving the LVAD implant
rehospitalization rate
Time frame: between day of surgery and 31.12.2019
rehospitalization rate of patients after receiving the LVAD implant
1 secondary outcome
survival rate
Time frame: between day of surgery and 31.12.2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Derived from this study: PubMed 33789723Schaeffer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Grapow, Prof Dr. med. principal investigator
HerzZentrum Hirslanden Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Implant Complication, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 days mortality (time frame: 30 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04263012, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.