Left Ventricular DysfunctionIMPACTNCT05529654
IMpella-Protected cArdiaC Surgery Trial (IMPACT)
A study testing Impella 5.5 with SmartAssist in people with Left Ventricular Dysfunction, run by Abiomed Inc. at 20 sites in United States.
Trial summary
The purpose of this Trial is to demonstrate the safety and effectiveness of the use of Impella 5.5 in high-risk cardiac surgery patients, with the overall aim to evaluate if using Impella 5.5 with SmartAssist (Impella 5.5) peri-operatively improves early hemodynamics, end-organ function and clinical outcomes in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Dysfunction
- What is being tested?
- Impella 5.5 with SmartAssist
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 20 sitesUnited States
- Study dates
- 21 Sep 2023to 3 Aug 2026
- Phase
- Interventional
- 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
Who may be able to join
- Hemodynamically stable patients undergoing one of the following cardiac surgery procedures on CPB including aortic cross-clamping and cardioplegic arrest:
- Isolated CABG
- Isolated mitral valve repair or mitral valve replacement (MVR)
- Isolated biological aortic valve replacement (AVR)
- At least two of the following: CABG, MVR, AVR, or tricuspid valve repair or replacement (TVR)
- Additional concomitant procedures permitted:
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- Atrial septal defect (ASD) or patent foramen ovale (PFO) repair or closure
- Atrial fibrillation ablation procedures
- Left atrial ablation (all forms including complete left/right side Cox Maze)
- Coronary endarterectomy
- LVEF within 30 days before surgery of either:
- ≤25% measured by echocardiogram or cardiac MRI, OR
- LVEF ≤35%, measured as above, for patients with significant mitral regurgitation (MR 3+ or 4+) and planned corrective mitral valve surgery (including MV replacement or repair)
- Any subject with EF <20% must have viability assessment performed to assess CABG candidacy (MRI preferred)
- Age 18 years or older
- Subject (or subject's LAR, if allowed by IRB) has signed Informed Consent Form
Who cannot join
- Salvage operation (cardiac arrest within 24 hours prior to index surgery)
- Unresponsive state within 24 hours of the time of surgery
- Any inotrope within 72 hours of surgery
- Any MCS device (such as IABP, ECMO, Impella®, CentriMag™ or TandemHeart®) in place at time of informed consent and less than 24 hours prior to index study procedure
- RV dysfunction requiring mechanical or inotropic support pre-operatively and/or likely to be needed post-operatively
- Index procedures requiring total circulatory arrest (TCA), such as aortic arch replacement, planned durable LVAD, durable RVAD, planned right-sided temporary mechanical support of any kind, total artificial heart (TAH), cardiac transplantation, pericardiectomy, pulmonary thromboendarterectomy and septal myectomy
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- Restrictive or obstructive cardiomyopathy, constrictive pericarditis, restrictive pericarditis, pericardial tamponade or other conditions in which cardiac output is dependent on venous return
- Ventricular septal defect (VSD)
- Stroke within 30 days of the index cardiac surgical procedure
- Prior mantle field chest irradiation
- Prior solid organ or hematologic transplantation (heart, kidney, liver, lung, pancreas, bone marrow) or durable LVAD
- History of chronic dialysis
- Pre-existing liver dysfunction defined as: Child-Pugh Class B or C
- Pre-existing pulmonary disease requiring home oxygen or "severe pulmonary disease" determined by enrolling Investigator
- Systemic active infection or evidence of systemic bacterial, fungal or viral infection within 72 hours before surgery (blood culture positive with leukocytosis)
- Confirmed COVID-19 infection within two weeks prior to operation
- Suspected or known pregnancy
- Participation in the active treatment or follow-up phase of another interventional clinical trial of an investigational drug or device which has not reached its primary endpoint
- Known contraindication to heparin; History of bleeding diathesis or known coagulopathy or will refuse blood transfusions
- Inability to perform aortic cross-clamp, such as due to porcelain aorta
- Any contraindication or inability to place Impella 5.5 (per the IFU), including LV thrombus and/or presence of a mechanical aortic valve
- Any organ condition, concomitant disease (e.g., psychiatric illness, current severe alcoholism or current drug abuse, cancer, hepatic or kidney disease), with life expectancy of ≤2 years or other abnormality that itself or the treatment of which could interfere with the conduct of the trial or that, in the opinion of the investigator and/or Sponsor's medical monitor, would pose an unacceptable risk to the patient in the trial.
- Patient has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with trial procedures
- Patient belongs to a vulnerable population [Vulnerable patient populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention]
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Emory University Hospital
Atlanta, Georgia, 30322
University of Texas Austin Dell Medical School/Ascension Texas
Austin, Texas, 78705
Mass General Hospital
Boston, Massachusetts, 02114
Brigham & Women's
Boston, Massachusetts, 02115
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Cardiology Associates Research Group
Jonesboro, Arkansas, 72401
Keck School of Medicine
Los Angeles, California, 90033
Minneapolis Heart Institute Foundation/Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
NCH Rooney Heart Institute
Naples, Florida, 34102
Centennial Heart Cardiovascular
Nashville, Tennessee, 37203
NYU Langone Health
New York, New York, 10016
New York- Presbyterian Hospital/ Columbia University Medical Center
New York, New York, 10032
Hospital of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Baylor Scott and White - Plano
Plano, Texas, 75093
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Tri-City Medical Center
San Diego, California, 92056
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10467
New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
About this study
The purpose of this Trial is to demonstrate the safety and effectiveness of the use of Impella 5.5 in high-risk cardiac surgery patients, with the overall aim to evaluate if using Impella 5.5 with SmartAssist (Impella 5.5) peri-operatively improves early hemodynamics, end-organ function and clinical outcomes in patients with severely reduced LV function undergoing cardiac surgery.
Read the detailed description
This is a prospective single-armed Trial to demonstrate the safety and effectiveness of the use of Impella 5.5 in high-risk cardiac surgery patients. A concurrent Registry will also be performed to collect information on patients meeting Exclusion Criteria and those not approached for enrollment. The overall aim is to evaluate if using Impella 5.5 peri-operatively improves early hemodynamics, end-organ function and subsequent clinical outcomes in patients with severely reduced LV function undergoing cardiac surgery.
- Conditions
- Left Ventricular Dysfunction
- Being tested
- Impella 5.5 with SmartAssist
- Keywords
- High-risk Cardiac Surgery, Low pre-operative left ventricular ejection fraction, Cardiopulmonary bypass (CPB), Temporary Mechanical Circulatory System (MCS)
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impella 5.5 with SmartAssistDevice
For subjects enrolled in the Trial, the Impella 5.5 will be placed intra-operatively during the index cardiac surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Impella Arm | Experimental | Impella 5.5 with SmartAssist Receives: Device: Impella 5.5 with SmartAssist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of All-Cause Mortality
Measured: 90 days
Stroke (as defined by STS)
Measured: 90 days
New requirement for Renal Replacement Therapy (RRT)
Measured: 90 days
Rate of Post-Cardiotomy Cardiac Failure
The rate of post-cardiotomy cardiac failure evaluated at hospital discharge.
Measured: Hospital discharge, usually within 30 days
Secondary outcomes (14)
Number of attempts to wean from CPB
Measured: Intra-op, usually within 1 day
Duration of mechanical ventilation
Measured: ICU discharge, usually within 30 days
Duration and dosages of inotropes and vasopressors. Duration of mechanical circulatory support (Hours)
measured in number of hours of dosage
Measured: ICU Discharge, usually within 30 days
Acute Kidney Injury
a modified KDIGO Stages 2-3
Measured: within 7 days or at ICU Discharge (usually within 30 days)
Vasoactive-inotropic score (VIS)
Measured: ICU Discharge, usually within 30 days
Cardiovascular mortality
Measured: Hospital discharge, usually within 30 days
Major Hemolysis
defined by MCS-ARC
Measured: Hospital Discharge, usually within 30 days
Major Vascular Complications
defined by MCS-ARC
Measured: Hospital Discharge, usually within 30 days
Major Bleeding
defined by STS
Measured: Hospital Discharge, usually within 30 days
Length of ICU Stay
Measured: ICU Discharge, usually within 30 days
Length of Hospital Stay
Measured: Hospital Discharge, usually within 30 days
Quality of Life (QoL) assessed by KCCQ
Measured: 90 Days Post-Op
Physical Activity
Measured by (Katz Activities of Daily Living (ADL) and Lawton Instrumental ADL (IADL)
Measured: 90 Days Post-Op
Technical Success
The successful use of the Impella 5.5 device will be assessed by the proportion of patients who undergo successful Impella implant, as well as the proportion of patients demonstrating successful wean off CPB.
Measured: Intra-op, usually within 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start21 Sep 2023
- Primary completion4 Nov 2025
- Study completion3 Aug 2026
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 Left Ventricular DysfunctionStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Goldstein, MD, Principal investigator, Montefiore Medical CenterEdward Soltesz, MD, Principal investigator, The Cleveland ClinicHermann Reichenspurner, MD, PhD, Principal investigator, University Heart & Vascular Center Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529654
- Sponsor's protocol ID
- VV-TMF-20447
- Acronym
- IMPACT
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2022
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Goldstein DJ, Reichenspurner H, Vorovich E, Teuteberg J, Ramzy D, Lobdell KW, Parks RJ, May A, Aggarwal S, Soltesz EG. Design and rationale of the Impella(R)-protected cardiac surgery trial (IMPACT): A multicenter, single-arm pilot study in high-risk cardiac surgery patients. Am Heart J. 2026 Jul;297:107434. doi: 10.1016/j.ahj.2026.107434. Epub 2026 Mar 25.
PubMed 41895564
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMpella-Protected cArdiaC Surgery Trial (IMPACT)
- ClinicalTrials.gov ID
- NCT05529654
- Acronym / sponsor ID
- IMPACT / VV-TMF-20447
- Conditions
- Left Ventricular Dysfunction
- Keywords
- High-risk Cardiac Surgery, Low pre-operative left ventricular ejection fraction, Cardiopulmonary bypass (CPB), Temporary Mechanical Circulatory System (MCS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 3 Aug 2026 (actual)
- First posted
- 7 Sep 2022 (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 purpose of this Trial is to demonstrate the safety and effectiveness of the use of Impella 5.5 in high-risk cardiac surgery patients, with the overall aim to evaluate if using Impella 5.5 with SmartAssist (Impella 5.5) peri-operatively improves early hemodynamics, end-organ function and clinical outcomes in patients with severely reduced LV function undergoing cardiac surgery.
Detailed description
This is a prospective single-armed Trial to demonstrate the safety and effectiveness of the use of Impella 5.5 in high-risk cardiac surgery patients. A concurrent Registry will also be performed to collect information on patients meeting Exclusion Criteria and those not approached for enrollment. The overall aim is to evaluate if using Impella 5.5 peri-operatively improves early hemodynamics, end-organ function and subsequent clinical outcomes in patients with severely reduced LV function undergoing cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Impella Arm | Experimental | Device: Impella 5.5 with SmartAssistImpella 5.5 with SmartAssist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Hemodynamically stable patients undergoing one of the following cardiac surgery procedures on CPB including aortic cross-clamping and cardioplegic arrest:
- LVEF within 30 days before surgery of either:
- Age 18 years or older
- Subject (or subject's LAR, if allowed by IRB) has signed Informed Consent Form
Key exclusion criteria (24 listed)
- Salvage operation (cardiac arrest within 24 hours prior to index surgery)
- Unresponsive state within 24 hours of the time of surgery
- Any inotrope within 72 hours of surgery
- Any MCS device (such as IABP, ECMO, Impella®, CentriMag™ or TandemHeart®) in place at time of informed consent and less than 24 hours prior to index study procedure
- RV dysfunction requiring mechanical or inotropic support pre-operatively and/or likely to be needed post-operatively
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 |
|---|---|---|
| Impella 5.5 with SmartAssistFor subjects enrolled in the Trial, the Impella 5.5 will be placed intra-operatively during the index cardiac surgical procedure | Device | Impella Arm |
Primary outcome
Composite of All-Cause Mortality
Time frame: 90 days
Stroke (as defined by STS)
Time frame: 90 days
New requirement for Renal Replacement Therapy (RRT)
Time frame: 90 days
Rate of Post-Cardiotomy Cardiac Failure
Time frame: Hospital discharge, usually within 30 days
The rate of post-cardiotomy cardiac failure evaluated at hospital discharge.
14 secondary outcomes
Number of attempts to wean from CPB
Time frame: Intra-op, usually within 1 day
Duration of mechanical ventilation
Time frame: ICU discharge, usually within 30 days
Duration and dosages of inotropes and vasopressors. Duration of mechanical circulatory support (Hours)
Time frame: ICU Discharge, usually within 30 days
Acute Kidney Injury
Time frame: within 7 days or at ICU Discharge (usually within 30 days)
Vasoactive-inotropic score (VIS)
Time frame: ICU Discharge, usually within 30 days
Cardiovascular mortality
Time frame: Hospital discharge, usually within 30 days
Major Hemolysis
Time frame: Hospital Discharge, usually within 30 days
Major Vascular Complications
Time frame: Hospital Discharge, usually within 30 days
Major Bleeding
Time frame: Hospital Discharge, usually within 30 days
Length of ICU Stay
Time frame: ICU Discharge, usually within 30 days
Length of Hospital Stay
Time frame: Hospital Discharge, usually within 30 days
Quality of Life (QoL) assessed by KCCQ
Time frame: 90 Days Post-Op
Physical Activity
Time frame: 90 Days Post-Op
Technical Success
Time frame: Intra-op, usually within 1 day
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 28 Aug 2026.
- Derived from this study: PubMed 41895564Goldstein DJ, Reichenspurner H, Vorovich E, Teuteberg J, Ramzy D, Lobdell KW, Parks RJ, May A, Aggarwal S, Soltesz EG. Design and rationale of the Impella(R)-protected cardiac surgery trial (IMPACT): A multicenter, single-arm pilot study in high-risk cardiac surgery patients. Am Heart J. 2026 Jul;297:107434. doi: 10.1016/j.ahj.2026.107434. Epub 2026 Mar 25.
Related trials for Left Ventricular Dysfunction
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The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)
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RecruitingPhase 3
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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.
Daniel Goldstein, MD principal investigator
Montefiore Medical Center
Edward Soltesz, MD principal investigator
The Cleveland Clinic
Hermann Reichenspurner, MD, PhD principal investigator
University Heart & Vascular Center Hamburg
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impella 5.5 with SmartAssist in people with Left Ventricular Dysfunction, run by Abiomed Inc. at 20 sites 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 16 inclusion and 24 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 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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?
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?
Composite of All-Cause Mortality (time frame: 90 days). The study lists 4 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 NCT05529654, 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 28 Aug 2026.