Cardiogenic ShockLVAD-ECMONCT03583970
Veno-arterial Extracorporeal Membrane Oxygenation Prior to Left Ventricular Assist Device Implantation.
An observational study of Cardiogenic Shock and Heart Failure, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Cardiogenic shock is an uncommun pathology with a high mortatily rate around 45%. Veno arterial extracorporeal membrane oxygenation (VA-ECMO) is a temporary extracorporeal assist device which restore an adequate blood flow when a circulatory failure occures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Heart Failure, Extracorporeal Membrane Oxygenation
- What is being tested?
- Left Ventricular Assist Device Implantation
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jul 2018to 1 Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients between 01.01.2013 and 31.12.2017 in the participating centers implanted with LVAD during VA-ECMO therapy for refractory cardiogenic shock.
Who may be able to join
- Veno-arterial ExtraCorporeal Membrane Oxygenation prior to left ventricular assist device implantation.
- Veno-arterial ExtraCorporeal Membrane Oxygenation at the left ventricular assist device implantation operative time
Who cannot join
- ExtraCorporeal Membrane Oxygenation weaving before left ventricular assist device implantation.
- Cardiac assist devices other than Veno-arterial ExtraCorporeal Membrane Oxygenation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU Nancy
Nancy, 54000
Caroline FRITZ, MD, +33383157379, c.fritz@chru-nancy.fr
Bruno LEVY, MD-PhD, +33383154469, b.levy@chru-nancy.fr
About this study
Official title: Veno-arterial Extracorporeal Membrane Oxygenation Support Prior to Left Ventricular Assist Device Implantation : Initial Patients Characteristics and 6 Month Follow-up, a Retrospective Study (2013-2017) (LVAD-ECMO)
Cardiogenic shock is an uncommun pathology with a high mortatily rate around 45%. Veno arterial extracorporeal membrane oxygenation (VA-ECMO) is a temporary extracorporeal assist device which restore an adequate blood flow when a circulatory failure occures. VA-ECMO main indication is refractory cardiogenic shock whatever the etiology. Current medical care of terminal cardiac failure includes use of long-term mechanical circulatory support devices (MCSD) such as Left Ventricular Assist Device (LVAD). LVAD therapy may lead to heart transplant (bridge to transplantation), to recovery (bridge to recovery) or to permanent implantation (destination therapy). Few patients with refractory cardiogenic shock treated with VA-ECMO may secondarily need a long term MCSD with LVAD.
LVAD long-term heart assist showed interesting survival rate when implantation occured (71% after 2 years follow-up and 45% after 4 years follow-up) out of acute heart failure situation. There are only few datas concerning LVAD implantion during refractory cardiogenic shock, with a mortality between 20 to 50% in different studies.
In this way, in comparaison of current few datas on the subject of LVAD implantation under VA-ECMO, the investigators (15 french-speacking centers) would retrospectively describe a large population.
- Conditions
- Cardiogenic Shock, Heart Failure, Extracorporeal Membrane Oxygenation, Left Ventricular Assist Device
- Being tested
- Left Ventricular Assist Device Implantation
- Keywords
- Left Ventricular Assist Device, Extracorporeal Membrane Oxygenation, Refractory Cardiogenic Shock, Heart Failure, Cardiovascular diseases, Myocardial Infarction, Myocardial Ischemia, Shock
- Medical subject headings
- Shock, Cardiogenic, Heart Failure, Cardiovascular Diseases, Myocardial Infarction, Myocardial Ischemia, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Ventricular Assist Device ImplantationDevice
Veno-arterial extracorporeal membrane oxygenation prior to left ventricular assist device implantation : initial patients characteristics and 6 Month Follow-up
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month hospital discharge after LVAD implantation
6-month hospital discharge after LVAD implantation
Measured: 6 month after LVAD implantation
Secondary outcomes (3)
Mortality rate
Six month mortality rate after LVAD implantation
Measured: up to six month after LVAD implantation
ICU discharge
Days until ICU discharge after LVAD implantation
Measured: up to six month after LVAD implantation
Quality of life
ADL and IADL scale
Measured: up to six month after LVAD implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start5 Jul 2018
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline FRITZ, Central Hospital, Nancy, France
- Investigators
- Bruno Levy, MD-PhD, Study chair, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583970
- Sponsor's protocol ID
- PSS2017/LVADECMO-FRITZ/YB
- Acronym
- LVAD-ECMO
- Status last verified
- Jul 2018
- First submitted
- 6 Jun 2018
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veno-arterial Extracorporeal Membrane Oxygenation Support Prior to Left Ventricular Assist Device Implantation : Initial Patients Characteristics and 6 Month Follow-up, a Retrospective Study (2013-2017) (LVAD-ECMO)
- ClinicalTrials.gov ID
- NCT03583970
- Acronym / sponsor ID
- LVAD-ECMO / PSS2017/LVADECMO-FRITZ/YB
- Conditions
- Cardiogenic Shock, Heart Failure, Extracorporeal Membrane Oxygenation, Left Ventricular Assist Device
- Keywords
- Left Ventricular Assist Device, Extracorporeal Membrane Oxygenation, Refractory Cardiogenic Shock, Heart Failure, Cardiovascular diseases, Myocardial Infarction, Myocardial Ischemia, Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 12 Jul 2018 (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.
Cardiogenic shock is an uncommun pathology with a high mortatily rate around 45%. Veno arterial extracorporeal membrane oxygenation (VA-ECMO) is a temporary extracorporeal assist device which restore an adequate blood flow when a circulatory failure occures. VA-ECMO main indication is refractory cardiogenic shock whatever the etiology. Current medical care of terminal cardiac failure includes use of long-term mechanical circulatory support devices (MCSD) such as Left Ventricular Assist Device (LVAD). LVAD therapy may lead to heart transplant (bridge to transplantation), to recovery (bridge to recovery) or to permanent implantation (destination therapy). Few patients with refractory cardiogenic shock treated with VA-ECMO may secondarily need a long term MCSD with LVAD.
LVAD long-term heart assist showed interesting survival rate when implantation occured (71% after 2 years follow-up and 45% after 4 years follow-up) out of acute heart failure situation. There are only few datas concerning LVAD implantion during refractory cardiogenic shock, with a mortality between 20 to 50% in different studies.
In this way, in comparaison of current few datas on the subject of LVAD implantation under VA-ECMO, the investigators (15 french-speacking centers) would retrospectively describe a large population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients between 01.01.2013 and 31.12.2017 in the participating centers implanted with LVAD during VA-ECMO therapy for refractory cardiogenic shock.
Key inclusion criteria (2 listed)
- Veno-arterial ExtraCorporeal Membrane Oxygenation prior to left ventricular assist device implantation.
- Veno-arterial ExtraCorporeal Membrane Oxygenation at the left ventricular assist device implantation operative time
Key exclusion criteria (2 listed)
- ExtraCorporeal Membrane Oxygenation weaving before left ventricular assist device implantation.
- Cardiac assist devices other than Veno-arterial ExtraCorporeal Membrane Oxygenation
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 |
|---|---|---|
| Left Ventricular Assist Device ImplantationVeno-arterial extracorporeal membrane oxygenation prior to left ventricular assist device implantation : initial patients characteristics and 6 Month Follow-up | Device | – |
Primary outcome
6-month hospital discharge after LVAD implantation
Time frame: 6 month after LVAD implantation
6-month hospital discharge after LVAD implantation
3 secondary outcomes
Mortality rate
Time frame: up to six month after LVAD implantation
ICU discharge
Time frame: up to six month after LVAD implantation
Quality of life
Time frame: up to six month after LVAD implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
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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.
Bruno Levy, MD-PhD study chair
CHRU Nancy
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 Cardiogenic Shock and Heart Failure, run by Central Hospital, Nancy, France at 1 site in France.
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 2 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: status not confirmed, as of the sponsor's last update on 17 Jul 2018. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Fritz, MD (+3383157379, fritzcaro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month hospital discharge after LVAD implantation (time frame: 6 month after LVAD implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2018.