Status:
RECRUITING
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Heart Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 h...
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 pa...
Eligibility Criteria
Inclusion
- 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 \< 2.2 L/min/m².
- Limited functional status as demonstrated by 6MWT \< 300 m due to HF related reasons.
- 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 patient 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\. mean PAP \<30 mmHg
Exclusion
- Subject is \< 18 years of age at the time of informed consent.
- Any use of inotrope therapy 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, severe valvular heart disease, 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 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.
Key Trial Info
Start Date :
December 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2032
Estimated Enrollment :
850 Patients enrolled
Trial Details
Trial ID
NCT06526195
Start Date
December 13 2024
End Date
September 1 2032
Last Update
November 3 2025
Active Locations (56)
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1
Banner-University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
2
Baptist Health Medical Center
Little Rock, Arkansas, United States, 72205
3
Sutter Medical Center
Sacramento, California, United States, 95816
4
University of California at San Francisco
San Francisco, California, United States, 94143