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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CardioMEMS HF System — DEVICE
  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 — DEVICE
  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 — OTHER
  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 Details

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.

Key Dates

Start date

Dec 13, 2024

Status verified

Jun 2026

Primary completion

Sep 30, 2029

Completion

Sep 30, 2032

Study Design

Enrollment

850 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Randomized Arm - HM3 Group
  Patients with elevated mean PAP (mean PAP ≥ 30 mmHg) and randomized to the HM3 group will receive the device within 14 days of randomization.
• Experimental: Randomized Arm - Control Group
  Patients with elevated mean PAP (mean PAP ≥ 30 mmHg) and randomized to the control group will continue their medical therapy per established heart failure guidelines.
• Experimental: Single Arm Registry
  Patients who do not meet the mean PAP threshold (mean PAP \<30 mmHg) and are enrolled in the single arm will continue their medical therapy per established heart failure guidelines.

Primary Outcome Measure

Survival at 2 years free of disabling stroke, reoperation to replace the device, or worsening HF requiring listing for urgent heart transplantation or mechanical circulatory support, enrollment into hospice, or dependence on IV inotropes [ Time Frame: 2 years ]

Central Contacts

• Nourdine Chakouri, PhD
  925-989-5982
  [email protected]

Locations (57)

Find similar trials in Phoenix, AZ

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