Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
Abbott Medical Devices · NCT06526195
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 850
- US sites recruiting
- 57
- Study start
- December 13, 2024
- Record last updated
- June 10, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.
Being studied: CardioMEMS HF System; HeartMate 3 Left Ventricular Assist System; Guideline Medical Directed Therapy
Conditions: Heart Failure; Heart Diseases; Cardiovascular Diseases; Pulmonary Hypertension
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Subject has provided written informed consent by signing the study Informed Consent Form (ICF) prior to any clinical investigation-related procedure
- LVEF ≤30% and Cardiac Index ≤ 2.5 L/min/m²
- Limited functional status as demonstrated by 6MWT ≤ 350 m due to HF related reasons OR peak VO2 ≤ 14 mL/kg/min (or \<50% of predicted peak VO2 value)
- NYHA Class IIIB or NYHA Class IV
- Subject has ≥ 1 Heart Failure Hospitalization in the last 12 months
- Subject is already implanted with a CardioMEMS PA Sensor OR willing to undergo a CardioMEMS PA Sensor implant
- Subject is willing and able to be implanted with the HM3 LVAS if randomized to HM3 Group
Randomization Criteria
- Subject has been implanted with a CardioMEMS PA Sensor for at least 90 days.
- Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days.
- mean PAP ≥ 30 mmHg.
- The subject will not be randomized if they have any other factor that represents inordinate risk for either continued GDMT or LVAD implant.
Single Arm Registry Criteria
- Subject has received a CardioMEMS PA Sensor implant following enrollment in the trial.
- Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days.
- mean PAP \<30 mmHg
Exclusion Criteria
- Subject is \< 18 years of age at the time of informed consent.
- Dependent on IV inotrope in the last 30 days.
- Contra-indications to HM3 LVAS or CardioMEMS HF system.
- Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy.
- Technical obstacles to LVAD or CardioMEMS implantation which pose an inordinately high surgical risk, in the judgment of the implanter.
- Existence of ongoing MCS.
- Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant.
- History of any solid organ transplant.
- Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management.
- Presence of an active, uncontrolled infection.
- Complex congenital heart disease.
- Currently Pregnant or capable of becoming Pregnant and Unwilling to Use Contraception with LVAD.
- History of pulmonary embolism within 30 days prior to enrollment or history of recurrent (>1 episode) pulmonary embolism and/or deep vein thrombosis.
- Planned VAD or Bi-VAD support prior to enrollment.
- Presence of any one of the following risk factors for or indications of severe end organ dysfunction or failure:
- An INR ≥ 2.0 not due to anticoagulation therapy
- An eGFR \< 30 mL/min/1.73 m2 and nonresponsive to diuretic therapy or receiving chronic dialysis.
- Biopsy proven liver cirrhosis.
- Need for chronic renal replacement therapy.
- History of severe chronic obstructive pulmonary disease (COPD) defined by Forced Expiratory Volume FEV1 \< 30% predicted.
- History of cerebrovascular disease with significant (> 80%) uncorrected internal carotid stenosis.
- Significant peripheral vascular disease (PVD) accompanied by ischemic rest pain or extremity ulceration.
- Any condition other than HF that could limit survival to less than 24 months.
- Participation in any other clinical investigation with an active treatment arm that is likely to confound study results or affect the study outcome.
Recruiting US locations
Banner-University Medical Center Phoenix
Phoenix, AZ 85006
Site contact: Abisola Akinbobola · 602-857-2052 · Abisola.Akinbobola@bannerhealth.com
Baptist Health Medical Center
Little Rock, AR 72205
Site contact: Victoria Marren · 678-654-0327 · victoria.marren@baptist-health.org
Sutter Medical Center
Sacramento, CA 95816
Site contact: Jessica Mccall · 916-887-4654 · jessica.mccall@sutterhealth.org
University of California at San Francisco
San Francisco, CA 94143
Site contact: Tyre Richardson · (209) 650-5302 · tyre.richardson@ucsf.edu
Washington Hospital Center
Washington D.C., DC 20010
Site contact: Hellina Birru · 202-877-6334 · hellina.t.birru@medstar.net
Shands at the University of Florida
Gainesville, FL 32610
Site contact: Erikson Walter · 269-331-9581 · erikson.walter@ufl.edu
Cleveland Clinic Florida
Weston, FL 33331
Site contact: Maria Mejia-Gomez · 954-659-5888 · mejiagm@ccf.org
Piedmont Heart Institute
Atlanta, GA 30309
Site contact: Andrew Bailey · 404-605-4098 · Andrew.Bailey1@piedmont.org
Piedmont Augusta Hospital
Augusta, GA 30901
Site contact: Jennifer Hansen · 706-724-2463 · jennifer.hansen@piedmont.org
WellStar Kennestone Hospital
Marietta, GA 30060
Site contact: Amuthanayaki Kanagaraj · 470-793-7554 · amuthanayaki.kanagaraj2@wellstar.org
University of Chicago
Chicago, IL 60637
Site contact: Kristen Hanauer · 773-702-8716 · kristen.hanauer@bsd.uchicago.edu
Advocate Health & Hospitals Corporation
Oakbrook Terrace, IL 60181
Site contact: Mairead Delaney · 708-684-4209 · mairead.delaney@aah.org
St. Vincent Hospital
Indianapolis, IN 46240
Site contact: Regina Margiotti · 317-338-6151 · Regina.Margiotti@ascension.org
University of Iowa Hospitals & Clinics
Iowa City, IA 52242
Site contact: Page Scovel · 319- 356-2585 · Page-scovel@uiowa.edu
Kansas University Medical Center
Kansas City, KS 66160
Site contact: Terry Christenson · 515-210-2626 · tchristenson3@kumc.edu
University of Kentucky
Lexington, KY 40536
Site contact: Brianna Grimm · 859-323-5366 · briigrimm@uky.edu
Norton Hospital
Louisville, KY 40202
Site contact: Laurie Michelle Jones · 502-891-8699 · laurie.jones@nortonhealthcare.org
Maine Medical Center
Portland, ME 04102
Site contact: Monica Palmeri · 207-662-2090 · monica.palmeri@mainehealth.org
Massachusetts General Hospital
Boston, MA 02114
Site contact: Bronwen Rees-Weidemann · 617-726-5508 · brees-wiedemann@mgh.harvard.edu
Henry Ford Hospital
Detroit, MI 48202
Site contact: Zack Malouf · 313-585-7068 · zmalouf1@hfhs.org
Spectrum Health Butterworth Hospital
Grand Rapids, MI 49503
Site contact: Stephanie Hanson · 616-391-0284 · stephanie.hanson@corewellhealth.org
Minneapolis Heart Institute
Minneapolis, MN 55407
Site contact: Kate Jappe · 612-863-7347 · Kate.Jappe@allina.com
Mayo Clinic
Rochester, MN 55905
Site contact: Colleen Irlbeck · 507-266-6879 · Irlbeck.Colleen@mayo.edu
St. Luke's Hospital
Kansas City, MO 64111
Site contact: Amanda Huffman · 816-932-0391 · ahuffman@saint-lukes.org
University of Nebraska Medical Center
Omaha, NE 68198
Site contact: Ryan Ruskamp · 402-836-9779 · ryan.ruskamp@unmc.edu
Hackensack University Medical Center
Hackensack, NJ 07601
Site contact: Manuel Castillo · 551-996-2136 · Manuel.Castillo@hmhn.org
Newark Beth Israel Medical Center
Newark, NJ 07112
Site contact: Patel Bhargavi · 516-600-1487 · bhargavi.patel2@rwjbh.org
New Mexico Heart Institute
Albuquerque, NM 87102
Site contact: Rebecca Jones · 505-843-2827 · Rebecca.Jones@lovelace.com
North Shore University Hospital
Manhasset, NY 11030
Site contact: Salome Reddy · 516-600-1459 · seliareddy@northwell.edu
New York-Presbyterian/Columbia University Medical Center
New York, NY 10032
Site contact: Jessica Idumonyi · 212-305-1368 · joi2102@cumc.columbia.edu
University of Rochester Medical Center
Rochester, NY 14642
Site contact: Lori Caufield · (585) 273-4956 · lori_caufield@urmc.rochester.edu
Montefiore Medical Center - Moses Campus
The Bronx, NY 10467
Site contact: Sabrina Sicilia · ssicilia@montefiore.org
University of North Carolina at Chapel Hill
Chapel Hill, NC 27599
Site contact: Hanna Mixon · (919) 962-4896 · hanna_mixon@med.unc.edu
Carolinas Medical Center
Charlotte, NC 28203
Site contact: Dana Amaro · 704-355-4794 · dana.amaro@atriumhealth.org
Christ Hospital
Cincinnati, OH 45219
Site contact: Susanne Pasley · 513-585-1777 · susanne.pasley@thechristhospital.com
The Cleveland Clinic Foundation
Cleveland, OH 44195
Site contact: Barbara Gus · 216-445-6552 · gusb@ccf.org
Integris Baptist Medical Center
Oklahoma City, OK 73112
Site contact: Jill Bethany Fife · (405) 951-8607 · bethany.fife@integrishealth.org
Oklahoma Heart Institute at Utica
Tulsa, OK 74104
Site contact: Allyson O'Guin · (918) 574-9253 · allyson.oguin@hillcrest.com
Saint Francis Hospital
Tulsa, OK 74136
Site contact: Riley Pritzlaff · 918-494-8500 · rpritzlaff@saintfrancis.com
Oregon Health & Science University
Portland, OR 97239
Site contact: Ricardo Mendoza · (503) 494-9511 · Mendozri@ohsu.edu
Abington Memorial Hospital
Abington, PA 19001
Site contact: Colleen Marchand · 215-481-4661 · colleen.marchand@jefferson.edu
Penn State Milton S. Hershey Medical Center
Hershey, PA 17033
Site contact: Amanda Donnangelo · 717-531-0850 · adonnangelo@pennstatehealth.psu.edu
University of Pennsylvania
Philadelphia, PA 19104
Site contact: Emma Markley · 585-273-3760 · Emma.markley@pennmedicine.upenn.edu
Allegheny General Hospital
Pittsburgh, PA 15212
Site contact: Laurie Machen · 412-359-6181 · Laurie.MACHEN@ahn.org
Medical University of South Carolina
Charleston, SC 29425
Site contact: Melissa Lamicq · 954-683-4648 · Lamicq@musc.edu
Prisma Health Midlands
Columbia, SC 29203
Site contact: Abigail Anderson · 864-455-7629 · Abigail.Anderson@prismahealth.org
The Stern Cardiovascular Foundation
Memphis, TN 38120
Site contact: Rishi Bhula · 901-271-2220 · rishi.bhula@sterncardio.com
Ascension Texas Cardiovascular
Austin, TX 78705
Site contact: Jennifer Mcsorley · 702-427-2014 · jennifer.mcsorley@ascension.org
Baylor University Hospital
Dallas, TX 75246
Site contact: Shelby Shull · 214-818-2587 · Shelby.Shull@BSWHealth.org
CHI St. Luke's Health Baylor College of Medicine Medical Center
Houston, TX 77030
Site contact: Wajeeha Abrar · (713) 798-5404 · Wajeeha.Abrar@bcm.edu
Houston Methodist
Houston, TX 77030
Site contact: Mary Kelly · (346) 238-8240 · makelly@houstonmethodist.org
UTHealth Memorial Hermann
Houston, TX 77030
Site contact: Lawana Self · 713-486-6751 · lawana.self@uth.tmc.edu
The Heart Hospital Baylor Plano
Plano, TX 75093
Site contact: Shelby McCoy · 469-814-3524 · shelby.mccoy@bswhealth.org
Scott & White Memorial Hospital
Temple, TX 76508
Site contact: Rohini Bagewadi · 254-724-1083 · rohini.bagewadi@bswhealth.org
University of Utah Hospital
Salt Lake City, UT 84132
Site contact: Ashley Elmer · 801-585-6775 · ashley.elmer@hsc.utah.edu
University of Virginia Medical Center
Charlottesville, VA 22908
Site contact: Tevin Jefferson · 434-982-1058 · MFU3QX@uvahealth.org
Aurora Medical Group
Milwaukee, WI 53215
Site contact: Don Lobacz · 414-649-3438 · donald.lobacz@aah.org
Study contacts (from the official record)
- Nourdine Chakouri, PhD · 925-989-5982 · nourdine.chakouri@abbott.com
Similar studies in Arizona
All heart & blood pressure studies in Arizona →- RecruitingHealthy volunteersPhase 1/Phase 2
Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
Atavistik Bio, Inc
- Location
- Phoenix, AZ + 5 other US sites
- Eligibility basics
- Ages 18+
- RecruitingHealthy volunteersPhase 1/Phase 2
A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
Novartis Pharmaceuticals
- Location
- Scottsdale, AZ + 18 other US sites
- Eligibility basics
- Ages 18–100
- RecruitingHealthy volunteersEarly Phase 1
Breathing for Two: Inspiratory Muscle Strength Training for Supporting Healthy Blood Pressure in Pregnancy
University of Arizona
- Location
- Tucson, AZ
- Eligibility basics
- Ages 18–55 · Women only
- RecruitingHealthy volunteers
BoxX-NoAF Clinical Trial
AtriCure, Inc.
- Location
- Scottsdale, AZ + 30 other US sites
- Eligibility basics
- Ages 65+