RECRUITING

Trial to Evaluate Safety and Effectiveness of Mechanical Circulatory Support in Patients with Advancing Heart Failure

Conditions

Heart Failure Heart Diseases Cardiovascular Diseases Pulmonary Hypertension 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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Trial to Evaluate Safety and Effectiveness of Mechanical Circulatory Support in Patients with Advancing Heart Failure

Quick Facts

Study Start:2024-12

Study Completion:2032-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06526195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 \< 2.2 L/min/m². 3. Limited functional status as demonstrated by 6MWT \< 300 m due to HF related reasons. 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 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 patient will not be randomized if they have any other factor that represents inordinate risk for either continued GDMT or LVAD implant. 1. mean PAP \<30 mmHg	1. Subject is \< 18 years of age at the time of informed consent. 2. Any use of inotrope therapy 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, severe valvular heart disease, 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 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.

Inclusion Criteria

Exclusion 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 \< 2.2 L/min/m².
3. Limited functional status as demonstrated by 6MWT \< 300 m due to HF related reasons.
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
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 patient will not be randomized if they have any other factor that represents inordinate risk for either continued GDMT or LVAD implant.
1. mean PAP \<30 mmHg

1. Subject is \< 18 years of age at the time of informed consent.
2. Any use of inotrope therapy 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, severe valvular heart disease, 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 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.

Contacts and Locations

Study Contact

Nourdine Chakouri, PhD

CONTACT

925-989-5982

nourdine.chakouri@abbott.com

Principal Investigator

Kelly O'Connell, PhD

STUDY_DIRECTOR

Abbott

Study Locations (Sites)

Kansas University Medical Center

Kansas City, Kansas, 66160

United States

Prisma Health Midlands

Columbia, South Carolina, 29203

United States

Collaborators and Investigators

Sponsor: Abbott Medical Devices

Kelly O'Connell, PhD, STUDY_DIRECTOR, Abbott

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12

Study Completion Date2032-09

Study Record Updates

Study Start Date2024-12

Study Completion Date2032-09

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Heart Failure
Heart Diseases
Cardiovascular Diseases
Pulmonary Hypertension