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Clinical Trials in Germany / NCT06526195
Recruiting Not applicable

Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure

NCT06526195 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2024-12-13
Last updated
2026-06-10

Condition(s) studied

Heart FailureHeart DiseasesCardiovascular DiseasesPulmonary Hypertension

Investigational drug(s) / intervention(s)

CardioMEMS HF SystemHeartMate 3 Left Ventricular Assist SystemGuideline Medical Directed Therapy

CardioMEMS HF System: 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 System: 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 Therapy: 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (68)

FacilityCityRegionStatus
Banner-University Medical Center Phoenix Phoenix Arizona Recruiting
Baptist Health Medical Center Little Rock Arkansas Recruiting
Sutter Medical Center Sacramento California Recruiting
University of California at San Francisco San Francisco California Recruiting
Washington Hospital Center Washington D.C. District of Columbia Recruiting
Shands at the University of Florida Gainesville Florida Recruiting
Cleveland Clinic Florida Weston Florida Recruiting
Piedmont Heart Institute Atlanta Georgia Recruiting
Piedmont Augusta Hospital Augusta Georgia Recruiting
WellStar Kennestone Hospital Marietta Georgia Recruiting
University of Chicago Chicago Illinois Recruiting
Advocate Health & Hospitals Corporation Oakbrook Terrace Illinois Recruiting
St. Vincent Hospital Indianapolis Indiana Recruiting
University of Iowa Hospitals & Clinics Iowa City Iowa Recruiting
Kansas University Medical Center Kansas City Kansas Recruiting
University of Kentucky Lexington Kentucky Recruiting
Norton Hospital Louisville Kentucky Recruiting
Maine Medical Center Portland Maine Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Henry Ford Hospital Detroit Michigan Recruiting
Spectrum Health Butterworth Hospital Grand Rapids Michigan Recruiting
Minneapolis Heart Institute Minneapolis Minnesota Recruiting
Mayo Clinic Rochester Minnesota Recruiting
St. Luke's Hospital Kansas City Missouri Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
Hackensack University Medical Center Hackensack New Jersey Recruiting
Newark Beth Israel Medical Center Newark New Jersey Recruiting
New Mexico Heart Institute Albuquerque New Mexico Recruiting
North Shore University Hospital Manhasset New York Recruiting
New York-Presbyterian/Columbia University Medical Center New York New York Recruiting
University of Rochester Medical Center Rochester New York Recruiting
Montefiore Medical Center - Moses Campus The Bronx New York Recruiting
University of North Carolina at Chapel Hill Chapel Hill North Carolina Recruiting
Carolinas Medical Center Charlotte North Carolina Recruiting
Christ Hospital Cincinnati Ohio Recruiting
The Cleveland Clinic Foundation Cleveland Ohio Recruiting
Integris Baptist Medical Center Oklahoma City Oklahoma Recruiting
Oklahoma Heart Institute at Utica Tulsa Oklahoma Recruiting
Saint Francis Hospital Tulsa Oklahoma Recruiting
Oregon Health & Science University Portland Oregon Recruiting

+ 28 more sites — see the full list on the official registry below.

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06526195 on ClinicalTrials.gov ↗ ← All trials in Germany