Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how safe and effective the HeartMate 3 heart pump is compared with recommended heart failure medicines. It is for people with advanced heart failure who can still walk around and do not depend on medicines given through a vein to help the heart pump.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Sign a consent form before any study procedures.
- Have a heart pumping strength (LVEF) of 30% or less and a cardiac index, a measure of blood flow, of 2.5 or less.
- Have limited activity due to heart failure: walk 350 meters or less in 6 minutes, or have low oxygen use on an exercise test.
- Have severe heart failure symptoms, called NYHA class IIIB or IV.
- Have at least one hospital stay for heart failure in the past 12 months.
- Already have, or agree to get, a CardioMEMS sensor to measure pressure in the lung artery.
- Be willing and able to get the HeartMate 3 pump if assigned to that group.
- For assignment to a treatment group, have the sensor for at least 90 days, an average lung artery pressure of at least 30 mmHg, and recommended medicines at the best tolerated doses for at least 30 of the last 90 days. A separate tracking group is for people with pressure below 30 mmHg who get the sensor after joining and meet the same medicine rule.
Who can't join
- Be younger than 18, or have depended on vein-given medicines to help the heart pump in the last 30 days.
- Have a medical reason not to use either device, unusually high implant surgery risk, current mechanical heart support, or plans for a heart pump before joining.
- Have certain causes of heart failure, such as untreated thyroid disease, certain thick or stiff heart muscle diseases, protein buildup called amyloidosis, or disease of the sac around the heart.
- Have complex heart defects present at birth, a past organ transplant, or a mechanical aortic heart valve that will not be replaced with a tissue valve or sewn closed during pump surgery.
- Have an active, uncontrolled infection, or mental health, lasting thinking, or social problems likely to prevent following study or pump care instructions.
- Be pregnant, or be able to become pregnant but unwilling to use birth control with the pump.
- Have a lung blood clot within 30 days, repeated lung or deep vein blood clots, or specified signs of severe kidney, liver, lung, blood vessel, or blood-clotting problems.
- Have another illness that could limit life to less than 24 months, join another treatment study that could affect these results, or have another factor making either study treatment unusually risky.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Subject has provided written informed consent by signing the study Informed Consent Form (ICF) prior to any clinical investigation-related procedure 2. LVEF ≤30% and Cardiac Index ≤ 2.5 L/min/m² 3. 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) 4. NYHA Class IIIB or NYHA Class IV 5. Subject has ≥ 1 Heart Failure Hospitalization in the last 12 months 6. Subject is already implanted with a CardioMEMS PA Sensor OR willing to undergo a CardioMEMS PA Sensor implant 7. Subject is willing and able to be implanted with the HM3 LVAS if randomized to HM3 Group Randomization Criteria: 1. Subject has been implanted with a CardioMEMS PA Sensor for at least 90 days. 2. 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. 3. mean PAP ≥ 30 mmHg. 4. 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: 1. Subject has received a CardioMEMS PA Sensor implant following enrollment in the trial. 2. 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. 3. mean PAP \<30 mmHg Exclusion Criteria: 1. Subject is \< 18 years of age at the time of informed consent. 2. Dependent on IV inotrope in the last 30 days. 3. Contra-indications to HM3 LVAS or CardioMEMS HF system. 4. Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy. 5. Technical obstacles to LVAD or CardioMEMS implantation which pose an inordinately high surgical risk, in the judgment of the implanter. 6. Existence of ongoing MCS. 7. Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant. 8. History of any solid organ transplant. 9. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management. 10. Presence of an active, uncontrolled infection. 11. Complex congenital heart disease. 12. Currently Pregnant or capable of becoming Pregnant and Unwilling to Use Contraception with LVAD. 13. History of pulmonary embolism within 30 days prior to enrollment or history of recurrent (\>1 episode) pulmonary embolism and/or deep vein thrombosis. 14. Planned VAD or Bi-VAD support prior to enrollment. 15. Presence of any one of the following risk factors for or indications of severe end organ dysfunction or failure: 1. An INR ≥ 2.0 not due to anticoagulation therapy 2. An eGFR \< 30 mL/min/1.73 m2 and nonresponsive to diuretic therapy or receiving chronic dialysis. 3. Biopsy proven liver cirrhosis. 4. Need for chronic renal replacement therapy. 5. History of severe chronic obstructive pulmonary disease (COPD) defined by Forced Expiratory Volume FEV1 \< 30% predicted. 6. History of cerebrovascular disease with significant (\> 80%) uncorrected internal carotid stenosis. 7. Significant peripheral vascular disease (PVD) accompanied by ischemic rest pain or extremity ulceration. 16. Any condition other than HF that could limit survival to less than 24 months. 17. Participation in any other clinical investigation with an active treatment arm that is likely to confound study results or affect the study outcome.
Study sites (57)
AR
- Baptist Health Medical Center · Little Rock, AR 72205Victoria Marren · Study contact · 678-654-0327 · victoria.marren@baptist-health.orgPatrick Campbell, MD · Principal investigatorMore trials in Little Rock
AZ
- Banner-University Medical Center Phoenix · Phoenix, AZ 85006Abisola Akinbobola · Study contact · 602-857-2052 · Abisola.Akinbobola@bannerhealth.comRadha Gopalan, MD · Principal investigatorMore trials in Phoenix
CA
- Sutter Medical Center · Sacramento, CA 95816Jessica Mccall · Study contact · 916-887-4654 · jessica.mccall@sutterhealth.orgMichael Gibson, MD · Principal investigatorMore trials in Sacramento
- University of California at San Francisco · San Francisco, CA 94143Tyre Richardson · Study contact · (209) 650-5302 · tyre.richardson@ucsf.eduShweta Motiwala, MD · Principal investigatorMore trials in San Francisco
DC
- Washington Hospital Center · Washington D.C., DC 20010Hellina Birru · Study contact · 202-877-6334 · hellina.t.birru@medstar.netSheikh Farooq, MD · Principal investigatorMore trials in Washington D.C.
FL
- Shands at the University of Florida · Gainesville, FL 32610Erikson Walter · Study contact · 269-331-9581 · erikson.walter@ufl.eduMustafa Ahmed, MD · Principal investigatorMore trials in Gainesville
- Cleveland Clinic Florida · Weston, FL 33331Maria Mejia-Gomez · Study contact · 954-659-5888 · mejiagm@ccf.orgMauricio Velez, MD · Principal investigatorMore trials in Weston
GA
- Piedmont Heart Institute · Atlanta, GA 30309Andrew Bailey · Study contact · 404-605-4098 · Andrew.Bailey1@piedmont.orgCatherine Marti, MD · Principal investigatorMore trials in Atlanta
- Piedmont Augusta Hospital · Augusta, GA 30901Jennifer Hansen · Study contact · 706-724-2463 · jennifer.hansen@piedmont.orgDarshak Karia, MD · Principal investigatorMore trials in Augusta
- WellStar Kennestone Hospital · Marietta, GA 30060Amuthanayaki Kanagaraj · Study contact · 470-793-7554 · amuthanayaki.kanagaraj2@wellstar.orgAbdul Bikak, MD · Principal investigatorMore trials in Marietta
IA
- University of Iowa Hospitals & Clinics · Iowa City, IA 52242Page Scovel · Study contact · 319- 356-2585 · Page-scovel@uiowa.eduAnthony Panos, MD · Principal investigatorMore trials in Iowa City
IL
- University of Chicago · Chicago, IL 60637Kristen Hanauer · Study contact · 773-702-8716 · kristen.hanauer@bsd.uchicago.eduNikhil Narang, MD · Principal investigatorMore trials in Chicago
- Advocate Health & Hospitals Corporation · Oakbrook Terrace, IL 60181Mairead Delaney · Study contact · 708-684-4209 · mairead.delaney@aah.orgVinh Chau, MD · Principal investigatorMore trials in Oakbrook Terrace
IN
- St. Vincent Hospital · Indianapolis, IN 46240Regina Margiotti · Study contact · 317-338-6151 · Regina.Margiotti@ascension.orgAshwin Ravichandran, MD · Principal investigatorMore trials in Indianapolis
KS
- Kansas University Medical Center · Kansas City, KS 66160Terry Christenson · Study contact · 515-210-2626 · tchristenson3@kumc.eduZubair Shah, MD · Principal investigatorMore trials in Kansas City
KY
- University of Kentucky · Lexington, KY 40536Brianna Grimm · Study contact · 859-323-5366 · briigrimm@uky.eduEmma Birks, MD · Principal investigatorMore trials in Lexington
- Norton Hospital · Louisville, KY 40202Laurie Michelle Jones · Study contact · 502-891-8699 · laurie.jones@nortonhealthcare.orgAlkhalil Bassel, MD · Principal investigatorMore trials in Louisville
MA
- Massachusetts General Hospital · Boston, MA 02114Bronwen Rees-Weidemann · Study contact · 617-726-5508 · brees-wiedemann@mgh.harvard.eduErin Coglianese, MD · Principal investigatorMore trials in Boston
ME
- Maine Medical Center · Portland, ME 04102Monica Palmeri · Study contact · 207-662-2090 · monica.palmeri@mainehealth.orgPeter Kennel, MD · Principal investigatorMore trials in Portland
MI
- Henry Ford Hospital · Detroit, MI 48202Zack Malouf · Study contact · 313-585-7068 · zmalouf1@hfhs.orgLindsey Aurora, MD · Principal investigatorMore trials in Detroit
- Spectrum Health Butterworth Hospital · Grand Rapids, MI 49503Stephanie Hanson · Study contact · 616-391-0284 · stephanie.hanson@corewellhealth.orgMatthew Gonzalez, MD · Principal investigatorMore trials in Grand Rapids
MN
- Minneapolis Heart Institute · Minneapolis, MN 55407Kate Jappe · Study contact · 612-863-7347 · Kate.Jappe@allina.comMosi Bennett, MD · Principal investigatorMore trials in Minneapolis
- Mayo Clinic · Rochester, MN 55905Colleen Irlbeck · Study contact · 507-266-6879 · Irlbeck.Colleen@mayo.eduAndrew Rosenbaum, MD · Principal investigatorMore trials in Rochester
MO
- St. Luke's Hospital · Kansas City, MO 64111Amanda Huffman · Study contact · 816-932-0391 · ahuffman@saint-lukes.orgTimothy Fendler, MD · Principal investigatorMore trials in Kansas City
NC
- University of North Carolina at Chapel Hill · Chapel Hill, NC 27599Hanna Mixon · Study contact · (919) 962-4896 · hanna_mixon@med.unc.eduWilliam Mostertz, MD · Principal investigatorMore trials in Chapel Hill
- Carolinas Medical Center · Charlotte, NC 28203Dana Amaro · Study contact · 704-355-4794 · dana.amaro@atriumhealth.orgSanjeev Gulati, MD · Principal investigatorMore trials in Charlotte
NE
- University of Nebraska Medical Center · Omaha, NE 68198Ryan Ruskamp · Study contact · 402-836-9779 · ryan.ruskamp@unmc.eduAdam Burdorf, DO · Principal investigatorMore trials in Omaha
NJ
- Hackensack University Medical Center · Hackensack, NJ 07601Manuel Castillo · Study contact · 551-996-2136 · Manuel.Castillo@hmhn.orgKanika Mody, MD · Principal investigatorMore trials in Hackensack
- Newark Beth Israel Medical Center · Newark, NJ 07112Patel Bhargavi · Study contact · 516-600-1487 · bhargavi.patel2@rwjbh.orgIgor Gosev, MD · Principal investigatorMore trials in Newark
NM
- New Mexico Heart Institute · Albuquerque, NM 87102Rebecca Jones · Study contact · 505-843-2827 · Rebecca.Jones@lovelace.comEddie Brown, MD · Principal investigatorMore trials in Albuquerque
NY
- North Shore University Hospital · Manhasset, NY 11030Salome Reddy · Study contact · 516-600-1459 · seliareddy@northwell.eduMaria Avila, MD · Principal investigatorMore trials in Manhasset
- New York-Presbyterian/Columbia University Medical Center · New York, NY 10032Jessica Idumonyi · Study contact · 212-305-1368 · joi2102@cumc.columbia.eduDor Lotan, MD · Principal investigatorMore trials in New York
- University of Rochester Medical Center · Rochester, NY 14642Lori Caufield · Study contact · (585) 273-4956 · lori_caufield@urmc.rochester.eduLeway Chen, MD · Principal investigatorMore trials in Rochester
- Montefiore Medical Center - Moses Campus · The Bronx, NY 10467Sabrina Sicilia · Study contact · ssicilia@montefiore.orgYogita Rochlani, MD · Principal investigatorMore trials in The Bronx
OH
- Christ Hospital · Cincinnati, OH 45219Susanne Pasley · Study contact · 513-585-1777 · susanne.pasley@thechristhospital.comEmani Sitaramesh, MD · Principal investigatorMore trials in Cincinnati
- The Cleveland Clinic Foundation · Cleveland, OH 44195Barbara Gus · Study contact · 216-445-6552 · gusb@ccf.orgMichael Tong, MD · Principal investigatorMore trials in Cleveland
OK
- Integris Baptist Medical Center · Oklahoma City, OK 73112Jill Bethany Fife · Study contact · (405) 951-8607 · bethany.fife@integrishealth.orgLuke Cunningham, MD · Principal investigatorMore trials in Oklahoma City
- Oklahoma Heart Institute at Utica · Tulsa, OK 74104Allyson O'Guin · Study contact · (918) 574-9253 · allyson.oguin@hillcrest.comLuis David Meggo Quiroz, MD · Principal investigatorMore trials in Tulsa
- Saint Francis Hospital · Tulsa, OK 74136Riley Pritzlaff · Study contact · 918-494-8500 · rpritzlaff@saintfrancis.comDouglas Ensley, MD · Principal investigatorMore trials in Tulsa
OR
- Oregon Health & Science University · Portland, OR 97239Ricardo Mendoza · Study contact · (503) 494-9511 · Mendozri@ohsu.eduJohannes Steiner, MD · Principal investigatorMore trials in Portland
PA
- Abington Memorial Hospital · Abington, PA 19001Colleen Marchand · Study contact · 215-481-4661 · colleen.marchand@jefferson.eduAlexander Shpilman, MD · Principal investigatorMore trials in Abington
- Penn State Milton S. Hershey Medical Center · Hershey, PA 17033Amanda Donnangelo · Study contact · 717-531-0850 · adonnangelo@pennstatehealth.psu.eduJohn Boehmer, MD · Principal investigatorMore trials in Hershey
- University of Pennsylvania · Philadelphia, PA 19104Emma Markley · Study contact · 585-273-3760 · Emma.markley@pennmedicine.upenn.eduHimabindu Vidula, MD · Principal investigatorMore trials in Philadelphia
- Allegheny General Hospital · Pittsburgh, PA 15212Laurie Machen · Study contact · 412-359-6181 · Laurie.MACHEN@ahn.orgMatthew Lander, MD · Principal investigatorMore trials in Pittsburgh
SC
- Medical University of South Carolina · Charleston, SC 29425Melissa Lamicq · Study contact · 954-683-4648 · Lamicq@musc.eduArman Kilic, MD · Principal investigatorMore trials in Charleston
- Prisma Health Midlands · Columbia, SC 29203Abigail Anderson · Study contact · 864-455-7629 · Abigail.Anderson@prismahealth.orgBrooks Ferguson · Study contact · 843-442-0994 · Brooks.Ferguson@prismahealth.orgJames Ampadu, MD · Principal investigatorMore trials in Columbia
TN
- The Stern Cardiovascular Foundation · Memphis, TN 38120Rishi Bhula · Study contact · 901-271-2220 · rishi.bhula@sterncardio.comDmitry Yaranov, MD · Principal investigatorMore trials in Memphis
TX
- Ascension Texas Cardiovascular · Austin, TX 78705Jennifer Mcsorley · Study contact · 702-427-2014 · jennifer.mcsorley@ascension.orgRaymond Bietry, MD · Principal investigatorMore trials in Austin
- Baylor University Hospital · Dallas, TX 75246Shelby Shull · Study contact · 214-818-2587 · Shelby.Shull@BSWHealth.orgCesar Guerrero-Miranda, MD · Principal investigatorMore trials in Dallas
- CHI St. Luke's Health Baylor College of Medicine Medical Center · Houston, TX 77030Wajeeha Abrar · Study contact · (713) 798-5404 · Wajeeha.Abrar@bcm.eduAjith Nair, MD · Principal investigatorMore trials in Houston
- Houston Methodist · Houston, TX 77030Mary Kelly · Study contact · (346) 238-8240 · makelly@houstonmethodist.orgCindy Martin, MD · Principal investigatorMore trials in Houston
- UTHealth Memorial Hermann · Houston, TX 77030Lawana Self · Study contact · 713-486-6751 · lawana.self@uth.tmc.eduNathan Sriram, MD · Principal investigatorMore trials in Houston
- The Heart Hospital Baylor Plano · Plano, TX 75093Shelby McCoy · Study contact · 469-814-3524 · shelby.mccoy@bswhealth.orgAasim Afzal, MD · Principal investigatorMore trials in Plano
- Scott & White Memorial Hospital · Temple, TX 76508Rohini Bagewadi · Study contact · 254-724-1083 · rohini.bagewadi@bswhealth.orgYevgeniy Khariton, MD · Principal investigatorMore trials in Temple
UT
- University of Utah Hospital · Salt Lake City, UT 84132Ashley Elmer · Study contact · 801-585-6775 · ashley.elmer@hsc.utah.eduCraig Selzman, MD · Principal investigatorMore trials in Salt Lake City
VA
- University of Virginia Medical Center · Charlottesville, VA 22908Tevin Jefferson · Study contact · 434-982-1058 · MFU3QX@uvahealth.orgMirnela Byku, MD · Principal investigatorMore trials in Charlottesville
WI
- Aurora Medical Group · Milwaukee, WI 53215Don Lobacz · Study contact · 414-649-3438 · donald.lobacz@aah.orgNasir Sulemanjee, MD · Principal investigatorMore trials in Milwaukee