NCT06526195

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 850 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 patients who are deemed to be dependent on continuous intravenous inotropes, extending life expectancy, enhancing overall quality of life, and improving functional capacity. However, use of LVADs in ambulatory, non-inotrope dependent advanced HF population is limited. Elevated mean pulmonary artery pressure (PAP) secondary to left ventricular failure has emerged as a potential predictor of increased mortality risk for patients refractory to maximally tolerated guideline directed medical therapy (GDMT). In these patients, left ventricular failure with elevated mean PAP may represent objective criteria to identify advanced HF patients requiring heart replacement therapies such as LVAD. The TEAM-HF IDE trial will enroll approximately 850 subjects with New York Heart Association (NYHA) Class IIIB/IV HF who had a prior heart failure hospitalization and an elevated mean PAP secondary to left ventricular failure. Elevated mean PAP will be identified using an implanted PAP monitoring sensor, the CardioMEMS PA Sensor. All subjects enrolled can have a previously implanted CardioMEMS PA Sensor or, if not, will be implanted with the CardioMEMS PA Sensor after enrollment. The overall objectives of TEAM-HF trial are two-fold: 1) To determine whether PAP can objectively identify patients most at risk for worsening HF and therefore most likely to benefit from earlier intervention with LVAD therapy and 2) To determine the benefit of LVAD therapy in non-inotrope advanced HF patients with elevated mean PAP refractory to GDMT. The trial will include approximately 75 global sites and consists of a Randomized Arm and a Single Arm Registry. The TEAM-HF Randomized Arm is a prospective, randomized, open-label study of the HeartMate 3 (HM3) left ventricular assist system (LVAS) versus continued GDMT in non-inotrope dependent HF patients. The objectives of the Randomized Arm are 1) To establish an objective disease-state criteria to trigger referral for a HM3 LVAS and 2) Demonstrate improvement in survival when non-inotrope dependent advanced HF patients are treated with the HM3 LVAS compared to being managed on medical therapy alone. The TEAM-HF Single Arm Registry is a prospective, single-arm, open-label study of non-inotrope dependent HF patients who do not meet a mean PAP threshold after GDMT optimization. The objective of the Single Arm Registry is to characterize the progression of patients with non-inotrope dependent HF without elevated PAP.

Conditions

• Heart Failure
• Heart Diseases
• Cardiovascular Diseases
• Pulmonary Hypertension

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.
OTHER	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.

Timeline

• Start date: 2024-12-13
• Primary completion: 2029-09-01
• Completion: 2032-09-01
• First posted: 2024-07-29
• Last updated: 2026-02-17

Locations

63 sites across 8 countries: United States, Austria, Czechia, Denmark, Germany, Italy, Netherlands, Saudi Arabia

Regulatory

• FDA-regulated device study