Abbott Initiates TEAM-HF Clinical Trial Using CardioMEMS HF System

November 11, 2024—Abbott recently announced plans to conduct the TEAM-HF clinical trial, which is designed to improve outcomes in patients with worsening heart failure (HF) who could benefit from advanced therapy options. The company advised that enrollment in TEAM-HF will commence shortly at sites across the United States.

The company stated that the trial seeks to establish new, objective criteria to identify patients most at risk for developing end-stage HF and potentially offer life-saving therapeutic options sooner in their disease progression.

According to Abbott, the TEAM-HF trial is planned to enroll up to 850 patients across 75 sites worldwide. It will measure pulmonary artery pressures (PAP) using Abbott’s CardioMEMS HF system to objectively identify advanced HF patients at high risk of mortality who could benefit from the company’s HeartMate 3 left ventricular assist device (LVAD) earlier in their disease progression.

The trial’s powered primary and secondary endpoints will be evaluated at 2 years, with long-term follow up through 5 years

Abbott noted in the press release that patients with end-stage HF who rely on intravenously administered HF medications have poor outcomes with a median survival of 9 months. Guideline recommendations for treating these patients include advanced therapies such as LVADs. However, patients who are not yet dependent on medication also have a poor clinical prognosis but are often not referred for these advanced options until their symptoms worsen. This delay is partly because of the lack of objective measures to identify patients who would most benefit from an LVAD, stated Abbott.

As outlined by Abbott, the TEAM-HF trial will deploy the following novel approach to assess the impact of earlier interventions in patients with worsening HF:

• Investigators will first examine PAP data securely collected from participants using the CardioMEMS HF system, which will be placed in the pulmonary artery via a minimally invasive outpatient procedure to monitor PAP changes over time.
• If pressures do not go down with guideline-directed medical therapy, the TEAM-HF trial will seek to prove that such patients will benefit from advanced therapies.
• These patients will be randomized to receive either the HeartMate 3 LVAD implant or continued treatment with their existing heart failure medications.
• Patients whose existing medications reduce their PAP levels will enter a single-arm registry where they will continue to be managed based on data from their CardioMEMS sensor.

Jennifer Cowger, MD, who is Medical Director of Mechanical Circulatory Support and the section head of the advanced heart failure program at Henry Ford Health in Detroit, Michigan, serves as one of the national Coprincipal Investigators for the TEAM-HF trial.

“The goal of the TEAM-HF trial is simple in concept but critical to the future care of patients,” commented Dr. Cowger in Abbott’s press release. “We want to break down patient care silos, offering a unified effort to not only improve the diagnosis of advanced heart failure, but also enable rapid access to life saving heart pumps.”

Dr. Cowger continued, “This study aims to take the guess work out of deciding when a patient has reached the ideal time for LVAD implementation. Too many patients are not receiving timely access to this life-saving therapy and are needlessly dying of heart failure. The importance of patient access to multidisciplinary heart failure care is embodied in the trial acronym—TEAM-HF—and we feel this study will be instrumental in helping providers identify patients who may benefit from a heart pump earlier in their care journey.”