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Tests treatment safety and results for Heart Failure
Official title Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
ClinicalTrials.gov ID: NCT06526195
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Technical obstacles to LVAD or CardioMEMS implantation which pose an inordinately high surgical risk, in the judgment of the implanter.
- Existence of ongoing MCS.
See the full eligibility 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 assigned by chance 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...
- mean PAP ≥ 30 mmHg.
- The subject will not be assigned by chance 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...
- mean PAP \<30 mmHg
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Washington D.C., District of Columbia, United States
- Gainesville, Florida, United States
- Weston, Florida, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Marietta, Georgia, United States
- Chicago, Illinois, United States
- Oakbrook Terrace, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Kansas City, Kansas, United States
- Lexington, Kentucky, United States
- Louisville, Kentucky, United States
- Portland, Maine, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
+ 44 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Sacramento, California, United States; San Francisco, California, United States; Washington D.C., District of Columbia, United States; Gainesville, Florida, United States and 58 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.