Heart FailureTEAM-HFNCT06526195
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
A study testing CardioMEMS HF System, HeartMate 3 Left Ventricular Assist System and Guideline Medical Directed Therapy in people with Heart Failure and Heart Diseases, run by Abbott Medical Devices at 68 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Diseases, Cardiovascular Diseases
- What is being tested?
- CardioMEMS HF System, HeartMate 3 Left Ventricular Assist System and Guideline Medical Directed Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 68 sitesin 8 countries
- Study dates
- 13 Dec 2024to Sep 2032
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
68 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
68 sites in 8 countries
United States57 sites, 57 recruiting
- Recruiting
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Colleen Marchand, 215-481-4661, colleen.marchand@jefferson.edu
Alexander Shpilman, MD
- Recruiting
New Mexico Heart Institute
Albuquerque, New Mexico, 87102
Rebecca Jones, 505-843-2827, Rebecca.Jones@lovelace.com
Eddie Brown, MD
- Recruiting
Piedmont Heart Institute
Atlanta, Georgia, 30309
Andrew Bailey, 404-605-4098, Andrew.Bailey1@piedmont.org
Catherine Marti, MD
- Recruiting
Piedmont Augusta Hospital
Augusta, Georgia, 30901
Jennifer Hansen, 706-724-2463, jennifer.hansen@piedmont.org
Darshak Karia, MD
- Recruiting
Ascension Texas Cardiovascular
Austin, Texas, 78705
Jennifer Mcsorley, 702-427-2014, jennifer.mcsorley@ascension.org
Raymond Bietry, MD
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Bronwen Rees-Weidemann, 617-726-5508, brees-wiedemann@mgh.harvard.edu
Erin Coglianese, MD
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Hanna Mixon, (919) 962-4896, hanna_mixon@med.unc.edu
William Mostertz, MD
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Melissa Lamicq, 954-683-4648, Lamicq@musc.edu
Arman Kilic, MD
- Recruiting
Carolinas Medical Center
Charlotte, North Carolina, 28203
Dana Amaro, 704-355-4794, dana.amaro@atriumhealth.org
Sanjeev Gulati, MD
- Recruiting
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Tevin Jefferson, 434-982-1058, MFU3QX@uvahealth.org
Mirnela Byku, MD
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Kristen Hanauer, 773-702-8716, kristen.hanauer@bsd.uchicago.edu
Nikhil Narang, MD
- Recruiting
Christ Hospital
Cincinnati, Ohio, 45219
Susanne Pasley, 513-585-1777, susanne.pasley@thechristhospital.com
Emani Sitaramesh, MD
- Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Barbara Gus, 216-445-6552, gusb@ccf.org
Michael Tong, MD
- Recruiting
Prisma Health Midlands
Columbia, South Carolina, 29203
Abigail Anderson, 864-455-7629, Abigail.Anderson@prismahealth.org
Brooks Ferguson, 843-442-0994, Brooks.Ferguson@prismahealth.org
- Recruiting
Baylor University Hospital
Dallas, Texas, 75246
Shelby Shull, 214-818-2587, Shelby.Shull@BSWHealth.org
Cesar Guerrero-Miranda, MD
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Zack Malouf, 313-585-7068, zmalouf1@hfhs.org
Lindsey Aurora, MD
- Recruiting
Shands at the University of Florida
Gainesville, Florida, 32610
Erikson Walter, 269-331-9581, erikson.walter@ufl.edu
Mustafa Ahmed, MD
- Recruiting
Spectrum Health Butterworth Hospital
Grand Rapids, Michigan, 49503
Stephanie Hanson, 616-391-0284, stephanie.hanson@corewellhealth.org
Matthew Gonzalez, MD
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Manuel Castillo, 551-996-2136, Manuel.Castillo@hmhn.org
Kanika Mody, MD
- Recruiting
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Amanda Donnangelo, 717-531-0850, adonnangelo@pennstatehealth.psu.edu
John Boehmer, MD
- Recruiting
CHI St. Luke's Health Baylor College of Medicine Medical Center
Houston, Texas, 77030
Wajeeha Abrar, (713) 798-5404, Wajeeha.Abrar@bcm.edu
Ajith Nair, MD
- Recruiting
Houston Methodist
Houston, Texas, 77030
Mary Kelly, (346) 238-8240, makelly@houstonmethodist.org
Cindy Martin, MD
- Recruiting
UTHealth Memorial Hermann
Houston, Texas, 77030
Lawana Self, 713-486-6751, lawana.self@uth.tmc.edu
Nathan Sriram, MD
- Recruiting
St. Vincent Hospital
Indianapolis, Indiana, 46240
Regina Margiotti, 317-338-6151, Regina.Margiotti@ascension.org
Ashwin Ravichandran, MD
- Recruiting
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
Page Scovel, 319- 356-2585, Page-scovel@uiowa.edu
Anthony Panos, MD
- Recruiting
Kansas University Medical Center
Kansas City, Kansas, 66160
Terry Christenson, 515-210-2626, tchristenson3@kumc.edu
Zubair Shah, MD
- Recruiting
St. Luke's Hospital
Kansas City, Missouri, 64111
Amanda Huffman, 816-932-0391, ahuffman@saint-lukes.org
Timothy Fendler, MD
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Brianna Grimm, 859-323-5366, briigrimm@uky.edu
Emma Birks, MD
- Recruiting
Baptist Health Medical Center
Little Rock, Arkansas, 72205
Victoria Marren, 678-654-0327, victoria.marren@baptist-health.org
Patrick Campbell, MD
- Recruiting
Norton Hospital
Louisville, Kentucky, 40202
Laurie Michelle Jones, 502-891-8699, laurie.jones@nortonhealthcare.org
Alkhalil Bassel, MD
- Recruiting
North Shore University Hospital
Manhasset, New York, 11030
Salome Reddy, 516-600-1459, seliareddy@northwell.edu
Maria Avila, MD
- Recruiting
WellStar Kennestone Hospital
Marietta, Georgia, 30060
Amuthanayaki Kanagaraj, 470-793-7554, amuthanayaki.kanagaraj2@wellstar.org
Abdul Bikak, MD
- Recruiting
The Stern Cardiovascular Foundation
Memphis, Tennessee, 38120
Rishi Bhula, 901-271-2220, rishi.bhula@sterncardio.com
Dmitry Yaranov, MD
- Recruiting
Aurora Medical Group
Milwaukee, Wisconsin, 53215
Don Lobacz, 414-649-3438, donald.lobacz@aah.org
Nasir Sulemanjee, MD
- Recruiting
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Kate Jappe, 612-863-7347, Kate.Jappe@allina.com
Mosi Bennett, MD
- Recruiting
New York-Presbyterian/Columbia University Medical Center
New York, New York, 10032
Jessica Idumonyi, 212-305-1368, joi2102@cumc.columbia.edu
Dor Lotan, MD
- Recruiting
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Patel Bhargavi, 516-600-1487, bhargavi.patel2@rwjbh.org
Igor Gosev, MD
- Recruiting
Advocate Health & Hospitals Corporation
Oakbrook Terrace, Illinois, 60181
Mairead Delaney, 708-684-4209, mairead.delaney@aah.org
Vinh Chau, MD
- Recruiting
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Jill Bethany Fife, (405) 951-8607, bethany.fife@integrishealth.org
Luke Cunningham, MD
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Ryan Ruskamp, 402-836-9779, ryan.ruskamp@unmc.edu
Adam Burdorf, DO
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Emma Markley, 585-273-3760, Emma.markley@pennmedicine.upenn.edu
Himabindu Vidula, MD
- Recruiting
Banner-University Medical Center Phoenix
Phoenix, Arizona, 85006
Abisola Akinbobola, 602-857-2052, Abisola.Akinbobola@bannerhealth.com
Radha Gopalan, MD
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Laurie Machen, 412-359-6181, Laurie.MACHEN@ahn.org
Matthew Lander, MD
- Recruiting
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Shelby McCoy, 469-814-3524, shelby.mccoy@bswhealth.org
Aasim Afzal, MD
- Recruiting
Maine Medical Center
Portland, Maine, 04102
Monica Palmeri, 207-662-2090, monica.palmeri@mainehealth.org
Peter Kennel, MD
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Ricardo Mendoza, (503) 494-9511, Mendozri@ohsu.edu
Johannes Steiner, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Colleen Irlbeck, 507-266-6879, Irlbeck.Colleen@mayo.edu
Andrew Rosenbaum, MD
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Lori Caufield, (585) 273-4956, lori_caufield@urmc.rochester.edu
Leway Chen, MD
- Recruiting
Sutter Medical Center
Sacramento, California, 95816
Jessica Mccall, 916-887-4654, jessica.mccall@sutterhealth.org
Michael Gibson, MD
- Recruiting
University of Utah Hospital
Salt Lake City, Utah, 84132
Ashley Elmer, 801-585-6775, ashley.elmer@hsc.utah.edu
Craig Selzman, MD
- Recruiting
University of California at San Francisco
San Francisco, California, 94143
Tyre Richardson, (209) 650-5302, tyre.richardson@ucsf.edu
Shweta Motiwala, MD
- Recruiting
Scott & White Memorial Hospital
Temple, Texas, 76508
Rohini Bagewadi, 254-724-1083, rohini.bagewadi@bswhealth.org
Yevgeniy Khariton, MD
- Recruiting
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
Sabrina Sicilia, ssicilia@montefiore.org
Yogita Rochlani, MD
- Recruiting
Oklahoma Heart Institute at Utica
Tulsa, Oklahoma, 74104
Allyson O'Guin, (918) 574-9253, allyson.oguin@hillcrest.com
Luis David Meggo Quiroz, MD
- Recruiting
Saint Francis Hospital
Tulsa, Oklahoma, 74136
Riley Pritzlaff, 918-494-8500, rpritzlaff@saintfrancis.com
Douglas Ensley, MD
- Recruiting
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Hellina Birru, 202-877-6334, hellina.t.birru@medstar.net
Sheikh Farooq, MD
- Recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
Maria Mejia-Gomez, 954-659-5888, mejiagm@ccf.org
Mauricio Velez, MD
Germany3 sites, 3 recruiting
- Recruiting
Deutsches Herzzentrum der Charité
Berlin, State of Berlin, 13353
Annegret Schneider, +49-304-593-2303, schneider@dhzb.de
Felix Schoenrath, MD
- Recruiting
Medizinische Hochschule Hannover
Hanover, Saxon, 30625
Antje Juergens, +49-0115-323-1113, juergens.antje@mh-hannover.de
Dominik Berliner, MD
- Recruiting
Herzzentrum Leipzig GmbH
Leipzig, Saxony, 04289
Victoria Himstedt, +49 341 865 25, victoria.himstedt@helios-health-institute.com
Michael Borger, MD
Netherlands2 sites, 2 recruiting
- Recruiting
Erasmus MC - Thoraxcenter
Rotterdam, Holland, 3015 CE
Nico Van Den Berg, +31-010-703-9307, n.berg@erasmusmc.nl
Rudolf De Boer, MD
- Recruiting
UMC Utrecht
Utrecht, Utrecht, 3584 CX
Manon Kuikhoven, (088) 755-9432, m.j.kuikhoven@umcutrecht.nl
Linda Van Laake, MD
Saudi Arabia2 sites, 2 recruiting
- Recruiting
King Fahad Medical City
Riyadh, Riyadh Region, 11525
Joud Hewaidi, +966-530003751, jhewaidi@kfmc.med.sa
Mohammed Alreshidan, MD
- Recruiting
King Faisal Specialist Hospital
Riyadh, Riyadh Region, 12713
Luluah Altukhaifi, +966 0556481098, laltukaifi@kfshrc.edu.sa
Jehad Abdulhamid Al Buraiki, MD
Austria1 site, 1 recruiting
- Recruiting
AKH -Wien
Vienna, State of Vienna, 1090
Julia Riebandt, MD, PhD, +43 1 40400-69660, julia.riebandt@meduniwien.ac.at
Daniel Zimpfer, MD
Czechia1 site, 1 recruiting
- Recruiting
IKEM Prague
Prague, CBohmia, 14021
+42 060 665 4220, martina.kucerova@ikem.cz
Ivan Netuka, MD
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, Copenhagen, 2100
Christina Moeller, +00 453 545 6757, Christina.Moeller@regionh.dk
Kasper Rossing, MD
Italy1 site, 1 recruiting
- Recruiting
A.O.U. Citta della Salute e della Scienza di Torino
Turin, Piedmont, 10126
Giuditta Cuccuru, +39 011 6335351, gcuccuru@cittadellasalute.to.it
Antonino Loforte, MD
About this study
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.
Read the detailed description
Patients with heart failure (HF) suffer from a high degree of morbidity and mortality. Left ventricular assist device (LVAD) therapy has become the standard of care for the treatment of advanced HF patients who are deemed to be dependent on continuous intravenous inotropes, extending life expectancy, enhancing overall quality of life, and improving functional capacity. However, use of LVADs in ambulatory, non-inotrope dependent advanced HF population is limited. Elevated mean pulmonary artery pressure (PAP) secondary to left ventricular failure has emerged as a potential predictor of increased mortality risk for patients refractory to maximally tolerated guideline directed medical therapy (GDMT). In these patients, left ventricular failure with elevated mean PAP may represent objective criteria to identify advanced HF patients requiring heart replacement therapies such as LVAD.
The TEAM-HF IDE trial will enroll approximately 850 subjects with New York Heart Association (NYHA) Class IIIB/IV HF who had a prior heart failure hospitalization and an elevated mean PAP secondary to left ventricular failure. Elevated mean PAP will be identified using an implanted PAP monitoring sensor, the CardioMEMS PA Sensor. All subjects enrolled can have a previously implanted CardioMEMS PA Sensor or, if not, will be implanted with the CardioMEMS PA Sensor after enrollment. The overall objectives of TEAM-HF trial are two-fold: 1) To determine whether PAP can objectively identify patients most at risk for worsening HF and therefore most likely to benefit from earlier intervention with LVAD therapy and 2) To determine the benefit of LVAD therapy in non-inotrope advanced HF patients with elevated mean PAP refractory to GDMT.
The trial will include approximately 75 global sites and consists of a Randomized Arm and a Single Arm Registry.
The TEAM-HF Randomized Arm is a prospective, randomized, open-label study of the HeartMate 3 (HM3) left ventricular assist system (LVAS) versus continued GDMT in non-inotrope dependent HF patients. The objectives of the Randomized Arm are 1) To establish an objective disease-state criteria to trigger referral for a HM3 LVAS and 2) Demonstrate improvement in survival when non-inotrope dependent advanced HF patients are treated with the HM3 LVAS compared to being managed on medical therapy alone.
The TEAM-HF Single Arm Registry is a prospective, single-arm, open-label study of non-inotrope dependent HF patients who do not meet a mean PAP threshold after GDMT optimization. The objective of the Single Arm Registry is to characterize the progression of patients with non-inotrope dependent HF without elevated PAP.
- Being tested
- CardioMEMS HF System, HeartMate 3 Left Ventricular Assist System, Guideline Medical Directed Therapy
- Keywords
- Heart Failure, Left Ventricular Assist Device (LVAD), Guideline Directed Medical Therapy (GDMT), Non-inotrope Dependent, Pulmonary Artery Pressure, Hemodynamic Monitoring, Medical Management, CardioMEMS, HeartMate 3 (HM3), Ambulatory Advanced Heart Failure
- Medical subject headings
- Heart Failure, Heart Diseases, Cardiovascular Diseases, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioMEMS HF SystemDevice
Also called CardioMEMS, CardioMEMS PA Sensor
The CardioMEMS™ HF System is comprised of a lead-less and battery-less pressure sensor which remotely transmits pulmonary artery pressure measurements.
HeartMate 3 Left Ventricular Assist SystemDevice
Also called HM3
The HeartMate 3 LVAS is a mechanical circulatory support pump with Full MagLev Technology that assumes some or all of the workload of the left ventricle. The HeartMate 3 LVAS is used in advanced heart failure patients needing short or long-term mechanical circulatory support.
Guideline Medical Directed TherapyOther
Also called GDMT
Optimal doses of medical therapy per established heart failure guidelines which includes the following stable combination of Beta Blockers, ACE-inhibitors or ARB or ARNi, MRA and SGLT2 inhibitors.
| Study group | Role | What they receive |
|---|---|---|
| Randomized Arm - HM3 Group | Experimental | Patients with elevated mean PAP (mean PAP ≥ 30 mmHg) and randomized to the HM3 group will receive the device within 14 days of randomization. Receives: Device: CardioMEMS HF System; Device: HeartMate 3 Left Ventricular Assist System; Other: Guideline Medical Directed Therapy |
| Randomized Arm - Control Group | Experimental | Patients with elevated mean PAP (mean PAP ≥ 30 mmHg) and randomized to the control group will continue their medical therapy per established heart failure guidelines. Receives: Device: CardioMEMS HF System; Other: Guideline Medical Directed Therapy |
| Single Arm Registry | Experimental | Patients who do not meet the mean PAP threshold (mean PAP <30 mmHg) and are enrolled in the single arm will continue their medical therapy per established heart failure guidelines. Receives: Device: CardioMEMS HF System; Other: Guideline Medical Directed Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at 2 years free of disabling stroke, reoperation to replace the device, or worsening HF requiring listing for urgent heart transplantation or mechanical circulatory support, enrollment into hospice, or dependence on IV inotropes
The powered primary endpoint will be analyzed at 2 years following the Com-Nougue method and will be compared between the HM3 Group (HM3 LVAD) and the Control Group (GDMT) within the Intention-to-treat (ITT) population.
Measured: 2 years
Secondary outcomes (8)
Rate of Safety Outcomes at 1-year
The powered secondary endpoint of Rate of Safety Outcomes at 1-year will be evaluated within the Intention-to-treat (ITT) population against a pre-specified performance goal.
Components consist of the following:
- Heart failure hospitalization
- Major Adverse Event (MAE) including:
- Stroke
- Non-surgical bleeding (>14 days post implant) requiring hospitalization
- Renal failure requiring hospitalization
- Driveline infection requiring hospitalization
Measured: 1 year
Survival at 2 years
The powered secondary endpoint of survival at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population.
Measured: 2 years
Quality of life score assessed with the Kansas City Cardiomyopathy Questionnaire
The secondary endpoint of Quality-of-life score at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of Quality of life at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.
The KCCQ scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. Improvement of KCCQ by at least 10 points is considered clinically significant.
Measured: 2 years
Six-minute walk distance
The secondary endpoint of six-minute walk distance at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of six-minute walk distance at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.
Measured: 2 years
Hospitalizations for HF and/or Urgent HF Visit
The secondary endpoint of Hospitalizations for HF and/or Urgent HF Visit at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of Hospitalizations for HF and/or Urgent HF Visit at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.
Measured: 2 years
Days alive and outside of the hospital
The secondary endpoint of days alive and outside of the hospital at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of days alive and outside of the hospital at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.
Measured: 2 years
All-cause hospitalizations
The secondary endpoint of all-cause hospitalizations at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of all-cause hospitalizations at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.
Measured: 2 years
All adverse events (including all strokes) regardless of severity
The secondary endpoint of all adverse events (including all strokes) regardless of severity at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of all adverse events (including all strokes) regardless of severity at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start13 Dec 2024
- Primary completionSep 2029 (estimated)
- Study completionSep 2032 (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 Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kelly O'Connell, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526195
- Sponsor's protocol ID
- ABT- CIP-10521
- Acronym
- TEAM-HF
- Status last verified
- Jun 2026
- First submitted
- 24 Jul 2024
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Jabr D, Pedersen R, Dahal A, Paredes-Flores M, Valika AA, Sulemanjee NZ, Pauwaa S, Dia M, Macaluso GP, Pillarella J, Joshi A, Sciamanna C, Dela Cruz M, Cotts WG, Matarieh AA, Gandhi HA, Hussain SM, Ezidinma AP, Narang N, Chau VQ. Hemodynamic Profiles During Pulmonary Artery Pressure Sensor Implantation: Risk Stratification in Chronic Heart Failure With Reduced Ejection Fraction. J Card Fail. 2025 Nov;31(11):1621-1630. doi: 10.1016/j.cardfail.2025.09.002. Epub 2025 Sep 27.
PubMed 41022266