Cardiogenic ShockNCT04084015
Early Insertion of Axillary Impella® With VA ECMO
A study testing Axillary Impella® in people with Cardiogenic Shock, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Veno-arterial extra-corporeal membrane oxygenation (VA-ECMO) is used as a rescue strategy for patients in acute hemodynamic deterioration such as cardiogenic shock and cardiopulmonary arrest with severe pulmonary congestion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Axillary Impella®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 23 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Age ≥18
- Impaired LV systolic function with ≤35% of left ventricular ejection fraction (LVEF)
- Enlarged LV with ≥50mm of left ventricular diastolic diameter (LVEDD) on echocardiogram
Who cannot join
- Non-cardiac etiology
- Surgically correctable cardiac abnormality
- Recent significant pulmonary embolism
- Severe pulmonary hypertension
- Acute aortic dissection
- Presence of mechanical aortic valve prosthesis
Show all 11Show fewer
- Presence of left ventricle thrombus
- Pre-existing Impella® 5.0
- Critical aortic stenosis
- Uncorrectable system malperfusion under ECMO support
- Significant cerebrovascular accident
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Early Insertion of Axillary Impella® for LV Recovery in Patients With Veno-arterial Extracorporeal Membrane Oxygenation
Veno-arterial extra-corporeal membrane oxygenation (VA-ECMO) is used as a rescue strategy for patients in acute hemodynamic deterioration such as cardiogenic shock and cardiopulmonary arrest with severe pulmonary congestion. VA ECMO is the fastest way to stabilize a patient with cardiogenic shock and improve end-organ perfusion. However, one of the major disadvantages of peripheral VA-ECMO is that it provides no left ventricular unloading and increases left ventricular (LV) afterload secondary to the retrograde blood flow. Therefore, LV wall tension and myocardial oxygen demand may actually increase in the setting of VA ECMO.
The Impella® device is a miniature rotary blood pump which can be inserted retrograde across the aortic valve. In this configuration, it withdraws blood from the LV and ejects it into the ascending aorta. It unloads the left ventricle, reducing LV wall tension and myocardial oxygen demand and increasing myocardial blood flow. The Impella® 5.0 is an FDA approved pump designed for intermediate support in patients with severe, cardiogenic shock. The axillary positioning allows for early extubation and ambulation and is more stable than groin placement.
Read more
In present practice, the decision to place an Impella® pump in VA-ECMO patients is based on the perceived need for direct LV unloading or when a bridge device is required to transition off ECMO support. Patients with peripheral VA ECMO are managed with inotropic agents at the beginning and once patients develop pulmonary edema mechanical LV unloading is considered electively. The advantage of LV unloading with Impella® has been demonstrated in recent studies. We also reported that concomitant implantation of Impella® with VA ECMO for LV unloading resulted in improved survival and recovery of ventricular performance in patients with cardiogenic shock. Compared to delayed elective LV unloading, early LV unloading could lead to decreased pulmonary edema, improved oxygenation delivery to the myocardium, increased chance of LV recovery and improved survival.
The objective of this prospective study is to assess whether the early direct ventricular unloading using axillary Impella® leads to higher rates of cardiac recovery, defined as survival free from mechanical circulatory support, heart transplantation or inotropic support at thirty days, compared with the conventional, elective placement of Impella® after developing significant pulmonary congestion.
Read the detailed description
This prospective, single-arm trial will include all consecutive patients undergoing cannulation of peripheral VA ECMO at the Massachusetts General Hospital (MGH) from April 2019 to March 2020. All enrolled patients will undergo surgical placement of Impella® via axillary artery within 48 hours after peripheral VA ECMO initiation and be managed with early extubation and ambulation strategy.
After Impella® placement, there will be no research procedures performed. Subjects will receive standard of care and the subject's progress will be documented throughout the 30 days study follow-up. The data obtained from the electronic medical record in Epic health record system at MGH will be reviewed throughout the study.
The primary outcome of this study will be survival at 30 days. Prespecified secondary end points will include the rate of death from cardiovascular causes, New York Heart Association (NYHA) functional class, LV function (assessed by echocardiography), and the rate of stroke, neurological functional status, acute kidney injury, vascular complications, and bleeding.
The enrolled subjects (early Impella®) would be compared with patients who underwent current elective placement of Impella® after cannulation of VA ECMO (elective Impella®) in the past two years. Student's t-test (for continuous variables) or Fisher exact test (for categorical variables) will be used for between-group comparisons. The primary endpoint in the data analysis is binary: 30-day survival. The null hypothesis of no difference between early Impella® and elective Impella® will be tested using logistic regression. The secondary endpoint, the rate of death from cardiovascular causes, NYHA functional class, LV function, and the rate of stroke, neurological functional status, acute kidney injury, vascular complications, and bleeding, will be addressed using competing risks hazard regression models. This is a pilot study for the future multicenter study. If this study demonstrates no inferiority or any significant superiority, we will proceed to do multicenter prospective study. Power analysis will be assessed based on the result of this preliminary study.
- Conditions
- Cardiogenic Shock
- Being tested
- Axillary Impella®
- Keywords
- Extracorporeal membrane oxygenation, Left ventricular unloading, Impella®
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary Impella®Device
All enrolled patients will undergo surgical placement of Impella® via axillary artery within 48 hours after peripheral VA ECMO initiation and be managed with early extubation and ambulation strategy
| Study group | Role | What they receive |
|---|---|---|
| Early axillary Impella® | Experimental | Early placement of axillary Impella® for LV unloading and LV recovery in patients with VA ECMO Receives: Device: Axillary Impella® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Patient survival at 30-days post VA ECMO cannulation timepoint. Collected through patient chart review.
Measured: 30 days after cannulation of VA ECMO
Secondary outcomes (4)
Death From Cardiovascular Causes
Death from cardiovascular cases at 30-days post VA ECMO cannulation timepoint. Collected from review of patient charts.
Measured: 30 days after cannulation of VA ECMO or Discharge
New York Heart Association Functional Status
Retrospective review in a patient chart
Measured: 30 days after cannulation of VA ECMO or Discharge
Number of Participants With a Neurological Event
Neurological event up to 30-days post VA-ECMO cannulation or Discharge. Includes hypoxic brain damage, intracerebral bleeding, hemorrhagic stroke, or ischemic stroke. Data collected through patient chart review.
Measured: 30 days after cannulation of VA ECMO or Discharge
Left Ventricular Function
Measured by Echocardiogram study.
Measured: 30 days after cannulation of VA ECMO or Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 Oct 2019
- Primary completion23 Mar 2021
- Study completion23 Mar 2021
Why it stopped: The study was prematurely stopped since enrollment was much slower than initially expected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This prospective, single-arm trial will include all consecutive patients undergoing cannulation of peripheral VA ECMO at the Massachusetts General Hospital from April 2019 to March 2020. Approximately 20 subjects are anticipated to be enrolled during this time.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David A. D'Alessandro, M.D., Massachusetts General Hospital
- Investigators
- David D'Alessandro, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084015
- Sponsor's protocol ID
- 2019P000668
- Status last verified
- Jun 2021
- First submitted
- 6 Sep 2019
- Last updated
- 29 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Neither identifiable nor non-identifiable data will be sent outside Partners or to Partners researchers not listed on the protocol.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Insertion of Axillary Impella® for LV Recovery in Patients With Veno-arterial Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT04084015
- Acronym / sponsor ID
- 2019P000668
- Conditions
- Cardiogenic Shock
- Keywords
- Extracorporeal membrane oxygenation, Left ventricular unloading, Impella®
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely stopped since enrollment was much slower than initially expected.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Posted 29 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Veno-arterial extra-corporeal membrane oxygenation (VA-ECMO) is used as a rescue strategy for patients in acute hemodynamic deterioration such as cardiogenic shock and cardiopulmonary arrest with severe pulmonary congestion. VA ECMO is the fastest way to stabilize a patient with cardiogenic shock and improve end-organ perfusion. However, one of the major disadvantages of peripheral VA-ECMO is that it provides no left ventricular unloading and increases left ventricular (LV) afterload secondary to the retrograde blood flow. Therefore, LV wall tension and myocardial oxygen demand may actually increase in the setting of VA ECMO.
The Impella® device is a miniature rotary blood pump which can be inserted retrograde across the aortic valve. In this configuration, it withdraws blood from the LV and ejects it into the ascending aorta. It unloads the left ventricle, reducing LV wall tension and myocardial oxygen demand and increasing myocardial blood flow. The Impella® 5.0 is an FDA approved pump designed for intermediate support in patients with severe, cardiogenic shock. The axillary positioning allows for early extubation and ambulation and is more stable than groin placement.
In present practice, the decision to place an Impella® pump in VA-ECMO patients is based on the perceived need for direct LV unloading or when a bridge device is required to transition off ECMO support. Patients with peripheral VA ECMO are managed with inotropic agents at the beginning and once patients develop pulmonary edema mechanical LV unloading is considered electively. The advantage of LV unloading with Impella® has been demonstrated in recent studies. We also reported that concomitant implantation of Impella® with VA ECMO for LV unloading resulted in improved survival and recovery of ventricular performance in patients with cardiogenic shock. Compared to delayed elective LV unloading, early LV unloading could lead to decreased pulmonary edema, improved oxygenation delivery to the myocardium, increased chance of LV recovery and improved survival.
The objective of this prospective study is to assess whether the early direct ventricular unloading using axillary Impella® leads to higher rates of cardiac recovery, defined as survival free from mechanical circulatory support, heart transplantation or inotropic support at thirty days, compared with the conventional, elective placement of Impella® after developing significant pulmonary congestion.
Detailed description
This prospective, single-arm trial will include all consecutive patients undergoing cannulation of peripheral VA ECMO at the Massachusetts General Hospital (MGH) from April 2019 to March 2020. All enrolled patients will undergo surgical placement of Impella® via axillary artery within 48 hours after peripheral VA ECMO initiation and be managed with early extubation and ambulation strategy.
After Impella® placement, there will be no research procedures performed. Subjects will receive standard of care and the subject's progress will be documented throughout the 30 days study follow-up. The data obtained from the electronic medical record in Epic health record system at MGH will be reviewed throughout the study.
The primary outcome of this study will be survival at 30 days. Prespecified secondary end points will include the rate of death from cardiovascular causes, New York Heart Association (NYHA) functional class, LV function (assessed by echocardiography), and the rate of stroke, neurological functional status, acute kidney injury, vascular complications, and bleeding.
The enrolled subjects (early Impella®) would be compared with patients who underwent current elective placement of Impella® after cannulation of VA ECMO (elective Impella®) in the past two years. Student's t-test (for continuous variables) or Fisher exact test (for categorical variables) will be used for between-group comparisons. The primary endpoint in the data analysis is binary: 30-day survival. The null hypothesis of no difference between early Impella® and elective Impella® will be tested using logistic regression. The secondary endpoint, the rate of death from cardiovascular causes, NYHA functional class, LV function, and the rate of stroke, neurological functional status, acute kidney injury, vascular complications, and bleeding, will be addressed using competing risks hazard regression models. This is a pilot study for the future multicenter study. If this study demonstrates no inferiority or any significant superiority, we will proceed to do multicenter prospective study. Power analysis will be assessed based on the result of this preliminary study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This prospective, single-arm trial will include all consecutive patients undergoing cannulation of peripheral VA ECMO at the Massachusetts General Hospital from April 2019 to March 2020. Approximately 20 subjects are anticipated to be enrolled during this time.
| Arm | Type | Receives |
|---|---|---|
| Early axillary Impella® | Experimental | Device: Axillary Impella®Early placement of axillary Impella® for LV unloading and LV recovery in patients with VA ECMO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18
- Impaired LV systolic function with ≤35% of left ventricular ejection fraction (LVEF)
- Enlarged LV with ≥50mm of left ventricular diastolic diameter (LVEDD) on echocardiogram
Key exclusion criteria (11 listed)
- Non-cardiac etiology
- Surgically correctable cardiac abnormality
- Recent significant pulmonary embolism
- Severe pulmonary hypertension
- Acute aortic dissection
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 |
|---|---|---|
| Axillary Impella®All enrolled patients will undergo surgical placement of Impella® via axillary artery within 48 hours after peripheral VA ECMO initiation and be managed with early extubation and ambulation strategy | Device | Early axillary Impella® |
Primary outcome
Survival
Time frame: 30 days after cannulation of VA ECMO
Patient survival at 30-days post VA ECMO cannulation timepoint. Collected through patient chart review.
4 secondary outcomes
Death From Cardiovascular Causes
Time frame: 30 days after cannulation of VA ECMO or Discharge
New York Heart Association Functional Status
Time frame: 30 days after cannulation of VA ECMO or Discharge
Number of Participants With a Neurological Event
Time frame: 30 days after cannulation of VA ECMO or Discharge
Left Ventricular Function
Time frame: 30 days after cannulation of VA ECMO or Discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Neither identifiable nor non-identifiable data will be sent outside Partners or to Partners researchers not listed on the protocol.
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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.
David D'Alessandro, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axillary Impella® in people with Cardiogenic Shock, run by Massachusetts General Hospital at 1 site in United States.
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 3 inclusion and 11 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: stopped early, as of the sponsor's last update on 29 Jun 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 29 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Survival (time frame: 30 days after cannulation of VA ECMO). 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 29 Jun 2021.