Abbott has launched the TEAM-HF ( терапии с помощью расширенных методов при сердечной недостаточности) trial, a first-of-its-kind clinical study designed to improve outcomes for heart failure patients through earlier intervention with advanced therapies. The trial aims to identify patients at high risk of mortality who could benefit from the HeartMate 3 left ventricular assist device (LVAD) earlier in their disease progression.
Utilizing CardioMEMS for Early Detection
The TEAM-HF trial will utilize Abbott's CardioMEMS HF system to remotely monitor pulmonary artery pressure (PAP) changes in heart failure patients. Implanted via a catheter-based procedure, CardioMEMS provides early warnings of worsening heart failure, allowing for timely intervention. The goal is to objectively identify patients who are not responding adequately to guideline-directed medical therapy and may be candidates for LVAD implantation.
Trial Design and Patient Enrollment
The trial plans to enroll 850 patients across 75 sites worldwide. Patients whose PAP levels remain elevated despite medical therapy will be randomized to receive either the HeartMate 3 LVAD or continued treatment with their existing medications. Patients whose PAP levels decrease with medication will be enrolled in a single-arm registry and managed based on CardioMEMS data.
Primary and Secondary Endpoints
Abbott plans to evaluate the powered primary and secondary endpoints at two years, with long-term follow-up through five years. The primary endpoint is a composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure. Secondary endpoints include changes in quality of life, functional capacity, and healthcare resource utilization.
Expert Perspectives
"The goal of the TEAM-HF trial is simple in concept but critical to the future care of patients... This study aims to take the guesswork out of deciding when a patient has reached the ideal time for LVAD implementation," said Dr. Jennifer Cowger, medical director of mechanical circulatory support and section head of the advanced heart failure program at Henry Ford Health, and one of the national co-principal investigators for the TEAM-HF trial.
Potential Impact on Heart Failure Care
Heart failure affects millions worldwide, and despite advances in medical therapy, many patients progress to advanced stages requiring more intensive interventions. The TEAM-HF trial seeks to demonstrate that earlier intervention with HeartMate 3, guided by CardioMEMS monitoring, can improve survival rates and quality of life for these patients. "By having more objective methods to accurately gauge heart failure progression and refer people to receive this life-saving therapy faster, healthcare experts will be able to provide patients with improved survival rates and quality of life based on the anticipated results of the TEAM-HF study," said Keith Boettiger, VP of Abbott’s heart failure business.
