Right Ventriculaire DysfunctionECPELLANCT04596982
Evaluation of Predictive Factors for Right Ventriculaire Dysfunction
An observational study of Right Ventriculaire Dysfunction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
An observational study of patients in cardiogenic shock under veno-arterial ECMO is designed to describe the clinical, ultrasound and hemodynamic parameters of these patients and to establish a predictive score for right-sided dysfunction in a patient within 48 hours of ECMO withdrawal after placement of IMPELLA®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Ventriculaire Dysfunction
- What is being tested?
- Placement of IMPELLA®
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2021to 25 Oct 2023
- 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 adult patients consecutively admitted to the cardiac medical and surgical intensive care units having : venoartrial ECMO and in whom the implantation of an assistance by IMPELLA is decided while waiting for the implantation of a left monoventricular assistance
Who may be able to join
- - Patient over 18 years of age
- - Patient under ECMO hospitalized in the medical intensive care unit or the surgical intensive care unit of the Groupement hospitalier Pitié-Salpêtrière, not weaned from ECMO, in whom it was decided at the multidisciplinary collegial meeting on assistance-transplantation to set up an IMPELLA before the implantation of left monoventricular assistance.
- - Patient who received informed information about the study and did not express opposition to participation in the research.
- Special Cases :
- o For patients who are unable to express their non-opposition, the investigator may request that of a relative of the patient.
- or For patients under guardianship, their non opposition must be obtained in the presence of the guardian.
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- or For patients under guardianship, it is the legal guardian's non opposition that will be requested.
- The modalities of information and obtaining the non opposition will be reported in the patient's medical file.
- - Patient affiliated or entitled to a French social security system -
Who cannot join
- - SAPS-II Score > 90 (Simplified Acute Physiology Score (SAPS-II) at Inclusion
- - Subject deprived of liberty by judicial decision
- - Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Predictive Factors for Right Ventriculaire Dysfunction Post Implantation of Left Mono Ventricular Assistance in Patients in Cardiogenic Shock Under Veno Arterial ECMO
An observational study of patients in cardiogenic shock under veno-arterial ECMO is designed to describe the clinical, ultrasound and hemodynamic parameters of these patients and to establish a predictive score for right-sided dysfunction in a patient within 48 hours of ECMO withdrawal after placement of IMPELLA®.
Read the detailed description
Therapeutic innovations in the field of heart failure are constant and have improved the prognosis and quality of life of patients. For those suffering from end-stage heart failure, heart transplantation remains the main therapeutic resource, but on the one hand the number of available grafts is insufficient compared to the number of transplant candidates, and on the other hand heart transplantation is accompanied by risks of rejection, infections and cancers, with a current median survival of 12 years .
For these reasons, in selected patients, a Left Ventricular Assist Device (LVAD) may be a bridge to transplantation or a way to improve the duration and quality of life of patients without a transplant project (destination therapy). Currently, about half of all heart transplants performed internationally are done in patients with left monoventricular assist, and in 2017 43% of implanted LVAD patients were in destination therapy.
For this reason, this observational study aims to describe the clinical, ultrasound and hemodynamic parameters of these patients and to establish a predictive score for right-sided dysfunction in a patient during the 30-day follow-up.
More precisely, during this study we will compare the clinical, ultrasound and hemodynamic parameters of these patients in order to establish a predictive score for right-sided dysfunction during :
- 48 hours on ECMO and IMPELLA (after IMPELLA® placement)
- 48 hours on IMPELLA alone following ECMO withdrawal.
- 48 hours under left monoventricular assistance
- At day 7 of the follow-up
- At day30 of the follow-up Patients who develop right heart failure within 48 hours of ECMO withdrawal after IMPELLA® placement will be compared to patients without right heart failure on demographic, clinical, history, treatment history, and cardiac echo and hemodynamic data at admission.
- Conditions
- Right Ventriculaire Dysfunction
- Being tested
- Placement of IMPELLA®
- Keywords
- ECMO, Right ventricule failure, Impella, circulatory support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of IMPELLA®Other
ultrasound and hemodynamic parameters of patients in order to establish a predictive score for right-sided dysfunction after placement of IMPELLA®
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of right heart failure or failure to withdraw ECMO due to right heart failure after placement of IMPELLA®.
The definition of right heart failure as defined by the INTERMACS takes into account the evolution of hemodynamic parameters during the 14 days following the implantation of the left monoventricular assist and is therefore not adapted to the situation of patients on veno-arterial ECMO who are going to have an IMPELLA for the purpose of ECMO weaning.
Measured: Within 48 hours of ECMO withdrawal after placement of IMPELLA®
Secondary outcomes (1)
Occurrence of severe right heart failure as defined by INTERMACS following implantation of left monoventricular assist
Association of PVC > 16 mmHg and :
- Continuation of inotropes or inhaled NO for more than 14 days. or
- A right circulatory assistance at any time after the implantation of the LVAD or
- Death related to right heart failure
Measured: During all the follow-up 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start9 Apr 2021
- Primary completion25 Oct 2023
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Ventriculaire DysfunctionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596982
- Sponsor's protocol ID
- APHP200528
- Acronym
- ECPELLA
- Status last verified
- Aug 2025
- First submitted
- 15 Oct 2020
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Predictive Factors for Right Ventriculaire Dysfunction Post Implantation of Left Mono Ventricular Assistance in Patients in Cardiogenic Shock Under Veno Arterial ECMO
- ClinicalTrials.gov ID
- NCT04596982
- Acronym / sponsor ID
- ECPELLA / APHP200528
- Conditions
- Right Ventriculaire Dysfunction
- Keywords
- ECMO, Right ventricule failure, Impella, circulatory support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 22 Oct 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.
An observational study of patients in cardiogenic shock under veno-arterial ECMO is designed to describe the clinical, ultrasound and hemodynamic parameters of these patients and to establish a predictive score for right-sided dysfunction in a patient within 48 hours of ECMO withdrawal after placement of IMPELLA®.
Detailed description
Therapeutic innovations in the field of heart failure are constant and have improved the prognosis and quality of life of patients. For those suffering from end-stage heart failure, heart transplantation remains the main therapeutic resource, but on the one hand the number of available grafts is insufficient compared to the number of transplant candidates, and on the other hand heart transplantation is accompanied by risks of rejection, infections and cancers, with a current median survival of 12 years .
For these reasons, in selected patients, a Left Ventricular Assist Device (LVAD) may be a bridge to transplantation or a way to improve the duration and quality of life of patients without a transplant project (destination therapy). Currently, about half of all heart transplants performed internationally are done in patients with left monoventricular assist, and in 2017 43% of implanted LVAD patients were in destination therapy.
For this reason, this observational study aims to describe the clinical, ultrasound and hemodynamic parameters of these patients and to establish a predictive score for right-sided dysfunction in a patient during the 30-day follow-up.
More precisely, during this study we will compare the clinical, ultrasound and hemodynamic parameters of these patients in order to establish a predictive score for right-sided dysfunction during :
- 48 hours on ECMO and IMPELLA (after IMPELLA® placement)
- 48 hours on IMPELLA alone following ECMO withdrawal.
- 48 hours under left monoventricular assistance
- At day 7 of the follow-up
- At day30 of the follow-up Patients who develop right heart failure within 48 hours of ECMO withdrawal after IMPELLA® placement will be compared to patients without right heart failure on demographic, clinical, history, treatment history, and cardiac echo and hemodynamic data at admission.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients consecutively admitted to the cardiac medical and surgical intensive care units having : venoartrial ECMO and in whom the implantation of an assistance by IMPELLA is decided while waiting for the implantation of a left monoventricular assistance
Key inclusion criteria (9 listed)
- - Patient over 18 years of age
- - Patient under ECMO hospitalized in the medical intensive care unit or the surgical intensive care unit of the Groupement hospitalier Pitié-Salpêtrière, not weaned from ECMO, in whom it was decided at the multidisciplinary collegial meeting on assistance-transplantation to set up an IMPELLA before the implantation of left monoventricular assistance.
- - Patient who received informed information about the study and did not express opposition to participation in the research.
- o For patients who are unable to express their non-opposition, the investigator may request that of a relative of the patient.
- or For patients under guardianship, their non opposition must be obtained in the presence of the guardian.
Key exclusion criteria (3 listed)
- - SAPS-II Score > 90 (Simplified Acute Physiology Score (SAPS-II) at Inclusion
- - Subject deprived of liberty by judicial decision
- - Pregnant or breastfeeding woman
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 |
|---|---|---|
| Placement of IMPELLA®ultrasound and hemodynamic parameters of patients in order to establish a predictive score for right-sided dysfunction after placement of IMPELLA® | Other | – |
Primary outcome
Absence of right heart failure or failure to withdraw ECMO due to right heart failure after placement of IMPELLA®.
Time frame: Within 48 hours of ECMO withdrawal after placement of IMPELLA®
The definition of right heart failure as defined by the INTERMACS takes into account the evolution of hemodynamic parameters during the 14 days following the implantation of the left monoventricular assist and is therefore not adapted to the situation of patients on veno-arterial ECMO who are going to have an IMPELLA for the purpose of ECMO weaning.
1 secondary outcome
Occurrence of severe right heart failure as defined by INTERMACS following implantation of left monoventricular assist
Time frame: During all the follow-up 30 days
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 22 Aug 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Right Ventriculaire Dysfunction, run by Assistance Publique - Hôpitaux de Paris 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 9 inclusion and 3 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 22 Aug 2025. 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?
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?
Absence of right heart failure or failure to withdraw ECMO due to right heart failure after placement of IMPELLA®. (time frame: Within 48 hours of ECMO withdrawal after placement of IMPELLA®). 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 22 Aug 2025; AzTrials last refreshed its copy on 29 Oct 2026.