Actively Recruiting
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
Led by Abbott Medical Devices · Updated on 2026-02-17
850
Participants Needed
63
Research Sites
402 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent by signing the study Informed Consent Form
- Left ventricular ejection fraction (LVEF) of 30% or less and cardiac index of 2.5 L/min/m² or less
- Limited functional status shown by a 6-minute walk test of 350 meters or less due to heart failure or peak oxygen consumption (VO2) 14 mL/kg/min or less (or less than 50% of predicted)
- Classified as NYHA Class IIIB or IV
- At least one heart failure hospitalization in the past 12 months
- Already implanted with a CardioMEMS PA Sensor or willing to undergo implantation
- Willing and able to receive HeartMate 3 LVAS if randomized to that group
- For randomization: CardioMEMS PA Sensor implanted for at least 90 days
- Receiving guideline directed medical therapy at optimal doses or documented intolerance for at least 30 of the last 90 days
- Mean pulmonary artery pressure of 30 mmHg or higher
- No other factors posing excessive risk for continued medical therapy or LVAD implant
- For single arm registry: CardioMEMS PA Sensor implanted after enrollment
- Receiving guideline directed medical therapy at optimal doses or documented intolerance for at least 30 of the last 90 days
- Mean pulmonary artery pressure less than 30 mmHg
You will not qualify if you...
- Younger than 18 years at informed consent
- Dependent on intravenous inotropes in the last 30 days
- Contraindications to HeartMate 3 LVAS or CardioMEMS HF system
- Heart failure caused by or related to untreated thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy
- Technical obstacles to LVAD or CardioMEMS implantation posing high surgical risk
- Ongoing mechanical circulatory support
- Presence of mechanical aortic valve not planned for conversion or oversewing at LVAD implant
- History of any solid organ transplant
- Psychiatric disease, irreversible cognitive dysfunction, or psychosocial issues likely to impair compliance
- Active, uncontrolled infection
- Complex congenital heart disease
- Currently pregnant or capable of becoming pregnant and unwilling to use contraception with LVAD
- Pulmonary embolism within 30 days prior to enrollment or history of recurrent pulmonary embolism or deep vein thrombosis
- Planned ventricular assist device or biventricular assist device support prior to enrollment
- Severe end organ dysfunction or failure indicated by any of the following: INR 2.0 or higher not due to anticoagulation, eGFR less than 30 mL/min/1.73 m² unresponsive to diuretics or on chronic dialysis, biopsy-proven liver cirrhosis, need for chronic renal replacement therapy, severe COPD with FEV1 less than 30% predicted, cerebrovascular disease with significant uncorrected carotid stenosis, or significant peripheral vascular disease with ischemic rest pain or ulcers
- Any condition other than heart failure limiting survival to less than 24 months
- Participation in another clinical investigation with an active treatment arm likely to affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 63 locations
1
Banner-University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
Baptist Health Medical Center
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
Sutter Medical Center
Sacramento, California, United States, 95816
Actively Recruiting
4
University of California at San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
5
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
6
Shands at the University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
7
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Actively Recruiting
8
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Actively Recruiting
9
Piedmont Augusta Hospital
Augusta, Georgia, United States, 30901
Actively Recruiting
10
WellStar Kennestone Hospital
Marietta, Georgia, United States, 30060
Actively Recruiting
11
Advocate Health & Hospitals Corporation
Oakbrook Terrace, Illinois, United States, 60181
Actively Recruiting
12
St. Vincent Hospital
Indianapolis, Indiana, United States, 46240
Actively Recruiting
13
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
14
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
15
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
16
Norton Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
17
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
18
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
19
Spectrum Health Butterworth Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
20
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
21
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
22
St. Luke's Hospital
Kansas City, Missouri, United States, 64111
Actively Recruiting
23
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
24
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
25
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Actively Recruiting
26
North Shore University Hospital
Manhasset, New York, United States, 11030
Actively Recruiting
27
New York-Presbyterian/Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
28
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
29
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
30
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
31
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Actively Recruiting
32
Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
33
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
34
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States, 73112
Actively Recruiting
35
Oklahoma Heart Institute at Utica
Tulsa, Oklahoma, United States, 74104
Actively Recruiting
36
Saint Francis Hospital
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
37
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
38
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Actively Recruiting
39
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
40
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
41
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
42
Prisma Health Midlands
Columbia, South Carolina, United States, 29203
Actively Recruiting
43
The Stern Cardiovascular Foundation
Memphis, Tennessee, United States, 38120
Actively Recruiting
44
Ascension Texas Cardiovascular
Austin, Texas, United States, 78705
Actively Recruiting
45
Baylor University Hospital
Dallas, Texas, United States, 75246
Actively Recruiting
46
CHI St. Luke's Health Baylor College of Medicine Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
47
Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
48
UTHealth Memorial Hermann
Houston, Texas, United States, 77030
Actively Recruiting
49
The Heart Hospital Baylor Plano
Plano, Texas, United States, 75093
Actively Recruiting
50
Scott & White Memorial Hospital
Temple, Texas, United States, 76508
Actively Recruiting
51
University of Utah Hospital
Salt Lake City, Utah, United States, 84132
Actively Recruiting
52
Aurora Medical Group
Milwaukee, Wisconsin, United States, 53215
Actively Recruiting
53
AKH -Wien
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
54
IKEM Prague
Prague, CBohmia, Czechia, 14021
Actively Recruiting
55
Rigshospitalet
Copenhagen, Copenhagen, Denmark, 2100
Actively Recruiting
56
Herzzentrum Leipzig GmbH
Leipzig, Saxony, Germany, 04289
Actively Recruiting
57
Medizinische Hochschule Hannover
Hanover, Saxon, Germany, 30625
Actively Recruiting
58
Deutsches Herzzentrum der Charité
Berlin, State of Berlin, Germany, 13353
Actively Recruiting
59
A.O.U. Citta della Salute e della Scienza di Torino
Turin, Piedmont, Italy, 10126
Actively Recruiting
60
Erasmus MC - Thoraxcenter
Rotterdam, Holland, Netherlands, 3015 CE
Actively Recruiting
61
UMC Utrecht
Utrecht, Utrecht, Netherlands, 3584 CX
Actively Recruiting
62
King Fahad Medical City
Riyadh, Riyadh Region, Saudi Arabia, 11525
Actively Recruiting
63
King Faisal Specialist Hospital
Riyadh, Riyadh Region, Saudi Arabia, 12713
Actively Recruiting
Research Team
N
Nourdine Chakouri, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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