Left Ventricular DysfunctionPROTECT IVNCT04763200
Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function
A study testing Impella CP® / Impella CP® with SmartAssist® / Impella 2.5® and IABP Intra-aortic balloon pump in people with Left Ventricular Dysfunction and Coronary Artery Disease, run by Abiomed Inc. at 110 sites in 7 countries.
Trial summary
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Left Ventricular Dysfunction, Coronary Artery Disease
- What is being tested?
- Impella CP® / Impella CP® with SmartAssist® / Impella 2.5® and IABP Intra-aortic balloon pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,252 participants
- Where
- 110 sitesin 7 countries
- Study dates
- 13 Apr 2021to Oct 2027
- Phase
- Interventional
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤90 years
- Clinical presentation and baseline left ventricular function are as follows: Either 2A or 2B must be present
- Subject has CCS or NSTEMI with an LVEF ≤40% NOTE: The LVEF must be quantitatively measured as ≤40% by echo within 30 days assuming no change in clinical condition. If multiple echos have been performed within 30-days, the most recent test must be used to qualify the patient. NOTE: Subject qualifies if the quantitative site read LVEF is ≤30%; if the quantitative site read is >30% - ≤40% the Echo Core Lab must confirm the LVEF is ≤40% before subject enrollment (Core Lab will provide <48-hour turnaround). Similarly, if the site read is qualitative only (i.e., only provides broad ranges without detailed LVEF quantification), the Echo Core Lab must confirm the LVEF is ≤40% before subject enrollment.
- OR
- Subject has STEMI ≥24 hours and <30 days after symptom onset with an LVEF ≤30% NOTE: In patients qualifying with recent STEMI, the LVEF must be demonstrated to be ≤30% by quantitative echocardiography after the primary PCI procedure (if performed) and within 72-hours prior to the planned randomization. If primary PCI was not performed, the qualifying echocardiogram will be the one taken during the index hospitalization closest to the index procedure. If the site read is qualitative only (i.e., only provides broad ranges without detailed LVEF quantification), the Echo Core Lab must confirm the LVEF is ≤30% before subject enrollment.
- Local heart team (interventional cardiologist and cardiac surgeon) has determined that PCI is indicated and is the most appropriate management for the patient
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- Complex PCI will be performed: Either 4A or 4B must be met
- One of the following must be present:
- Triple vessel disease is present (visually-assessed angiographic DS ≥80% [or ≥40% if non-invasive evidence of ischemia on a localizing stress test or invasive evidence of ischemia (FFR ≤0.80 or iFR ≤0.89)] is present in all 3 epicardial coronary artery distributions in a main vessel or branch with visually-assessed reference vessel diameter ≥2.5 mm) with PCI planned in ≥2 of these vessels in the proximal or mid LAD, proximal or mid-LCX or proximal, mid- or distal RCA [i.e., not a branch vessel])
- OR
- Left main distal bifurcation or trifurcation disease (visually-assessed DS ≥50% [or DS ≥30% if non-invasive evidence of ischemia in both the anterior and posterolateral distributions or left main IVUS MLA ≤6.0 mm2 or FFR ≤0.80 or iFR ≤0.89] is present) with planned intervention of the left main plus at least 2 branch vessels (i.e., the ostial LAD, ostial LCX or ostial ramus)
- OR
- Left main equivalent disease with both ostial LAD and ostial LCX having visually-assessed angiographic DS ≥80% [or ≥40% if non-invasive evidence of ischemia on a localizing stress test or invasive evidence of ischemia (FFR ≤0.80 or iFR ≤0.89] and requiring intervention in both branches
- OR
- Intervention of the last remaining vessel (native coronary artery or bypass graft)
- OR
- Multivessel disease is present (visually-assessed angiographic DS ≥80% [or ≥40% if non-invasive or invasive evidence of ischemia is present] in ≥2 of the 3 epicardial coronary artery distributions in a main vessel or branch with visually-assessed reference vessel diameter ≥2.5 mm) and PCI is planned of at least 2 separate complex lesions in main vessels or branch vessels each having one or more of the following characteristics:
- Long lesion (≥28 mm visually assessed) requiring ≥30 mm stent length (single or multiple)
- Severe angiographic calcification (see Protocol definition) or requiring atheroablation
- Any left main morphology not in Criterion A requiring intervention (e.g., isolated ostial or mid-shaft left main lesion or distal left main bifurcation lesion with a planned single provisional stent technique)
- Non-left main bifurcation lesion requiring intervention in both the main branch and side branch
- CTO (TIMI 0 Flow)
- Giant thrombus (length ≥3x vessel diameter)
- SVG (other than focal (<5 mm) disease of the proximal or distal anastomosis or in-stent restenosis)
- NOTES:
- The multiple lesions can be in the same vessel if separated by ≥10 mm - however, each separate lesion has to have one or more of the above characteristics
- PCI may be performed on additional non-qualifying lesions (i.e., without 1 or more of the above high-risk characteristics) as long as there are at least two lesions also undergoing PCI with each having 1 or more of the above characteristics)
- There are 2 exceptions to the rule that each separate lesion must have one or more of the above characteristics (as in Inclusion Criterion 4B above): The subject may qualify if undergoing complex PCI of a single lesion that has 2 or more of the above complex characteristics (as in Inclusion Criterion 4B above) if also:
- There is a CTO of a proximal or mid-LAD, proximal or mid-LCX or proximal, mid- or distal RCA (i.e., not a branch vessel) that will not be treated
- OR
- The subject qualifies with recent STEMI with an LVEF ≤30% and the complex PCI is planned in a non-infarct vessel (i.e., a complex PCI in the infarct vessel does not qualify)
- Subject or legal guardian (permitted at US sites only) agrees to randomization and to follow all study procedures and provides informed, written consent
Who cannot join
- Subjects must not meet ANY of the following Exclusion Criteria to participate in the Trial:
- STEMI ≤24 hours from the onset of ischemic symptoms or at any time if mechanical complications of transmural infarction are present (e.g., VSD, papillary muscle rupture, etc.)
- Cardiogenic shock (SBP <80 mmHg for ≥30 mins and not responsive to intravenous fluids or hemodynamic deterioration for any duration requiring pressors or mechanical circulatory support, including IABP)
- Subject is presently or recently intubated for the current admission (NOTE: recently intubated patients must be extubated for >24 hours with full neurologic recovery)
- Cardiorespiratory arrest related to the current admission unless subject is extubated for >24 hours with full neurologic recovery and hemodynamically stable
- Any contraindication or inability to Impella placement in both the left and right common femoral artery based on clinical or imaging findings, including iliofemoral artery diameter <5 mm, tortuous vascular anatomy or severe bilateral peripheral vascular disease of the iliac or femoral arteries that can't be adequately treated (e.g., with intravascular lithotripsy)
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- NOTES:
- Computed tomography (CT), magnetic resonance angiography (MRA) or contrast angiography to assess the aorta and iliofemoral vasculature to ensure Impella compatibility must be performed within 90 days prior to randomization. It is recommended that this evaluation be performed prior to the index procedure. Absent a qualifying pre-procedure imaging study, contrast angiography of the potential Impella access vessel(s) must be performed in the Cath Lab before the planned enrollment after which the subject may be randomized if he/she still qualifies. Of note, if pre-procedure imaging was performed and after this test but before randomization there was a worsening in PVD symptoms, repeat imaging must be performed prior to randomization.
- If iliofemoral peripheral vascular disease is present precluding Impella use that can be adequately treated with angioplasty, atherectomy or lithotripsy (without a stent), the subject can be enrolled if such treatment is undertaken and is successful and uncomplicated - randomization must not be performed until such successful and uncomplicated treatment
- Iliofemoral stents placed within 6 months of enrollment with planned vascular access through these vascular segments
- Vascular access for Impella is required in any location other than the left or right common femoral artery (i.e., axillary access, transcaval access, etc., for Impella access are not permitted)
- Known left ventricular thrombus
- Incessant ventricular arrhythmias that would likely preclude stable Impella positioning
- Severe aortic stenosis or severe aortic insufficiency
- Prior mechanical valve or self-expanding TAVR (NOTE: prior bioprosthetic surgical valve or balloon expandable TAVR implanted >24 hours pre-procedure is acceptable)
- Prior CABG within three (3) months or successful prior PCI of at least one (1) attempted lesion within 12 months (including during the index hospitalization prior to randomization), that has not experienced stent thrombosis or restenosis during that 12-month period; the one (1) exception is that patients may be enrolled if a primary PCI for STEMI was performed during the index hospitalization without MCS and that was ≥24 hours and <30 days prior to randomization.
- NOTE: Successful PCI for this exclusion criterion is defined as a visually-assessed angiographic DS ≤50% in at least one (1) attempted lesion.
- Prior placement of IABP, Impella or any other MCS device for any reason during the index admission, prior to randomization
- Known severe pulmonary hypertension (right ventricular systolic pressure (RVSP) on echo or pulmonary artery systolic pressure (PASP) on right heart catheterization) >70 mm Hg unless active vasodilator therapy in the Cath Lab is able to reduce the pulmonary vascular resistance (PVR) to <3 Wood Units or between 3 and 4.5 Wood Units with v-wave less than twice the mean of the pulmonary capillary wedge pressure
- Symptoms or signs of severe RV dysfunction, such as anasarca (NOTE: Leg edema alone does not necessarily indicate severe RV dysfunction if the investigator believes it is due to LV dysfunction)
- Severe tricuspid insufficiency
- Platelet count <75,000 cells/mm3, bleeding diathesis or active bleeding, coagulopathy or unwilling to receive blood transfusions
- On dialysis
- Prior stroke with any permanent neurologic deficit within the previous three (3) months, or any prior intracranial hemorrhage or any prior subdural hematoma or known intracranial pathology pre-disposing to intracranial bleeding, such as an arteriovenous malformation or mass
- Taking a chronic oral anticoagulant that cannot be safely discontinued for at least 72-hours before and 72-hours after the index procedure (if a vitamin K antagonist) or that cannot be safely discontinued for at least 48 hours before and 48 hours after the index procedure (for a direct acting oral anticoagulant)
- Plan for any surgery within 6 months necessitating discontinuing antiplatelet agents
- Pregnant or child-bearing potential unless negative pregnancy test within 1 week
- Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint
- Any medical or psychiatric condition such as dementia, alcoholism or substance abuse which may preclude informed consent or interfere with any of the study procedures, including follow-up visits
- Any non-cardiac condition with life expectancy <3 years (e.g., cirrhosis, oxygen or oral steroid dependent COPD, cancer not in remission, etc.)
- Subject is currently hospitalized for definite or suspected COVID-19
- Subject has previously been symptomatic with or hospitalized for COVID-19 unless he/she has been discharged (if hospitalized) and asymptomatic for ≥4 weeks and has returned to his/her prior baseline (pre-COVID) clinical condition
- Subject is asymptomatic (never ill) and COVID-19 PCR/antigen test is positive within the prior four (4) weeks unless a) subject remains asymptomatic for ≥2 weeks after the last positive test or b) the positive test occurred within six (6) months after the subject received a COVID vaccine
- Subject belongs to a vulnerable population (defined as individuals with mental disability, 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
110 sites in 7 countries.
110 sites in 7 countries
United States83 sites
Lovelace/New Mexico Heart Institute
Albuquerque, New Mexico, 87102
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Emory University Hospital
Atlanta, Georgia, 30322
University of Alabama
Birmingham, Alabama, 35294
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
SSM Health DePaul Hospital
Bridgeton, Missouri, 63044
University at Buffalo/Kaleida Health
Buffalo, New York, 14203
Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28204
Rush University Medical Center
Chicago, Illinois, 60612
Linder Research Center (The Christ Hospital)
Cincinnati, Ohio, 45219
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Metropolitan Heart and Vascular Institute / Metropolitan Cardiology Consultants
Coon Rapids, Minnesota, 55433
Presbyterian Hospital Dallas / Texas Health Physicians Group
Dallas, Texas, 75231
Henry Ford Hospital
Detroit, Michigan, 48202
Henry Ford St. John Hospital
Detroit, Michigan, 48236
Duke University
Durham, North Carolina, 27710
Englewood Hospital
Englewood, New Jersey, 07631
NorthShore University Health System
Evanston, Illinois, 60201
Northwestern University
Evanston, Illinois, 60208
Medical City Fort Worth
Fort Worth, Texas, 76104
The Cardiac & Vascular Institute
Gainesville, Florida, 32605
University of Florida Health - Gainesville
Gainesville, Florida, 32610
Adventist Health Glendale
Glendale, California, 91206
Corewell Health
Grand Rapids, Michigan, 49435
Greenville Hospital System
Greenville, South Carolina, 29605
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Hartford Hospital
Hartford, Connecticut, 06106
HCA Houston Healthcare
Houston, Texas, 77004
Houston Methodist Hospital
Houston, Texas, 77030
Memorial Hermann Texas Medical Center (UT Health)
Houston, Texas, 77030
Texas Heart Institute at Baylor St. Luke's Hospital
Houston, Texas, 77030
UF Health Jacksonville
Jacksonville, Florida, 32209
St. Luke's Hospital
Kansas City, Missouri, 64111
Wellmont Cardiology Services
Kingsport, Tennessee, 37660
Texas Cardiology Associates of Houston
Kingwood, Texas, 77339
Parkwest Medical Center
Knoxville, Tennessee, 37923
Colorado Heart and Vascular
Lakewood, Colorado, 80228
Northside Cardiovascular Institute
Lawrenceville, Georgia, 30043
Arkansas Cardiology
Little Rock, Arkansas, 72205
Norton Healthcare - Norton Heart Specialists
Louisville, Kentucky, 40205
Catholic Medical Center
Manchester, New Hampshire, 03102
Northwell University Hospital
Manhasset, New York, 11030
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
West Virginia University Hospital
Morgantown, West Virginia, 26506
Morristown Medical Center
Morristown, New Jersey, 07960
Centennial Heart - Nashville
Nashville, Tennessee, 37203
Ascension St. Thomas West
Nashville, Tennessee, 37205
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Jersey Shore University Medical Center
Neptune City, New Jersey, 07735
Ochsner Foundation Hospital
New Orleans, Louisiana, 70121
NYU Langone Health
New York, New York, 10016
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
Columbia University Medical Cenrer/NYPH
New York, New York, 10032
Sentara Norfolk Health System
Norfolk, Virginia, 23507
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
University of Oklahoma Medical Center
Oklahoma City, Oklahoma, 73104
St. Joseph Hospital - Orange
Orange, California, 92868
St. Joseph's Medical Center - Phoenix
Phoenix, Arizona, 85016
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Baylor Scott & White Heart - Plano
Plano, Texas, 75093
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Legacy Emanuel Hospital & Health Center
Portland, Oregon, 97232
North Carolina Heart and Vascular Research
Raleigh, North Carolina, 27607
Monument Health Clinical Research
Rapid City, South Dakota, 57701
The Valley Hospital - Ridgewood
Ridgewood, New Jersey, 07450
Carilion Clinic
Roanoke, Virginia, 24014
St. Francis Hospital and Heart Center
Roslyn, New York, 11576
CentraCare (St. Cloud Hospital)
Saint Cloud, Minnesota, 56303
Methodist Hospital - San Antonio
San Antonio, Texas, 78229
Loma Linda University Health
San Bernardino, California, 92354
UCSD Medical Center
San Diego, California, 92093
University Of Washington Medical Center
Seattle, Washington, 98195
Stony Brook University Hospital (SUNY)
Stony Brook, New York, 11794
Montefiore Medical Center - Moses
The Bronx, New York, 10467-2401
Northwest Medical Center Tucson
Tucson, Arizona, 85741
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Cardiovascular Research Institute of Kansas
Wichita, Kansas, 67226
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
WellSpan York Hospital
York, Pennsylvania, 17403
Germany17 sites
University Hospital Aachen
Aachen, 52074
Universitätsklinikum Freiburg, Universitäts-Herzzentrum
Bad Krozingen, 79189
Berlin CBF
Berlin, 12203
CVK Berlin
Berlin, 13353
Klinikum Chemnitz gGmbH
Chemnitz, 09116
St. Vinzenz-Hospital GMBH KÖLN
Cologne, 50733
Herzzentrum Dresden GmbH
Dresden, 01307
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Universitätsklinikum Essen AöR
Essen, 45147
University Hopsital Frankfurt
Frankfurt
Klinikum Friedrichshafen GmbH
Friedrichshafen, 88048
Universitätsklinikum Gießen
Giessen, 35392
Klinikum Karlsburg
Karlsburg, Mecklenburg-Vorpommern, 17495
Klinikum rechts der Isar der TUM
Munich, Bavaria, 81675
Krankenhaus der Barmherzigen Brüder
Trier, Rhineland-Palatinate, 54292
Uniklinik Würzburg
Würzburg, 97080
Canada3 sites
Royal Victoria Hospital
Montreal, Quebec, H4A 3J1
Toronto General Hospital
Toronto, Ontario
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
Switzerland3 sites
Inselspital Bern
Bern, 3010
Luzerner Kantonsspital
Lucerne, 6000
Istituto Cardiocentro Ticino
Lugano, Canton Ticino, 6900
Italy2 sites
Policlinico Universitario Agostino Gemelli
Rome, RM, 00168
Ospedale di San Donato
San Donato Milanese
Netherlands1 site
Catharina Ziekenhuis Eindhoven
Eindhoven, North Brabant, 5623 EJ
About this study
Official title: Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function: The PROTECT IV Trial
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care.
Read the detailed description
To demonstrate that in high-risk patients with complex CAD and reduced left ventricular function undergoing PCI, PCI with Impella MCS is superior to PCI without Impella MCS in reducing the composite rate of all-cause death, stroke, MI, unplanned clinically driven revascularization, durable LVAD implant or heart transplant, or other hospitalization for cardiovascular causes at 3-year follow-up.
- Being tested
- Impella CP® / Impella CP® with SmartAssist® / Impella 2.5®, IABP Intra-aortic balloon pump
- Keywords
- Non-ST Elevated Myocardial Infarction, Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia, Myocardial Infarction, Anterior Wall Myocardial Infarction, Inferior Wall Myocardial Infarction
- Medical subject headings
- Ventricular Dysfunction, Left, Coronary Artery Disease, Non-ST Elevated Myocardial Infarction, Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia, Myocardial Infarction, Anterior Wall Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impella CP® / Impella CP® with SmartAssist® / Impella 2.5®Device
Impella CP / Impella CP with SmartAssist will be used in most patients randomized to the Impella arm. Impella 2.5 may be used in patients with small body size (BMI <20 kg/m2 or body weight <60 kg) or if the iliofemoral vasculature is able to accommodate the smaller Impella 2.5 device but not the Impella CP device.
IABP Intra-aortic balloon pumpDevice
IABP uses counterpulsation to provide 0.2L/min coronary flow
| Study group | Role | What they receive |
|---|---|---|
| Impella Arm | Experimental | Impella CP® or Impella 2.5 placement prior to high-risk PCI Receives: Device: Impella CP® / Impella CP® with SmartAssist® / Impella 2.5® |
| Control Arm | Active comparator | Subjects randomized to the Control group will be treated per standard of care PCI with or without an intra-aortic balloon pump (IABP). Receives: Device: IABP Intra-aortic balloon pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite of all-cause death, stroke, MI, unplanned clinically driven revascularization, durable LVAD implant or heart transplant, or other hospitalization for cardiovascular (CV) causes.
Measured: 3 years
Secondary outcomes (7)
Death or NYHA Class III or IV
Measured: 1 year
Improvement in KCCQ
Measured: Baseline to 6 months
All CV hospitalizations through 3 years
Measured: 3 years
Composite of CV death, stroke, MI, unplanned clinically driven revascularization, durable LVAD implant or heart transplant, or other hospitalization for cardiovascular causes through 3 years
Measured: 3 years
CV death or HF hospitalizations through 3 years
Measured: 3 years
Improvement in LVEF based on ANCOVA regression with inclusion of baseline LVEF measurement as a covariate
Measured: Baseline to 6 months
Achievement of complete anatomic revascularization after the index and planned staged procedures
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start13 Apr 2021
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, randomized, parallel-controlled, open-label two-arm trial with an adaptive design.
- Masking
- None (open label)
- Enrolment
- 1,252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763200
- Sponsor's protocol ID
- VV-TMF-18508
- Acronym
- PROTECT IV
- Status last verified
- Mar 2026
- First submitted
- 4 Feb 2021
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Lusebrink E, Kellnar A, Krieg K, Binzenhofer L, Scherer C, Zimmer S, Schrage B, Fichtner S, Petzold T, Braun D, Peterss S, Brunner S, Hagl C, Westermann D, Hausleiter J, Massberg S, Thiele H, Schafer A, Orban M. Percutaneous Transvalvular Microaxial Flow Pump Support in Cardiology. Circulation. 2022 Apr 19;145(16):1254-1284. doi: 10.1161/CIRCULATIONAHA.121.058229. Epub 2022 Apr 18.
PubMed 35436135