The Abbott TEAM-HF trial, involving 850 patients across 75 sites globally, is designed to measure pulmonary artery pressure data using Abbott’s CardioMEMS HF System to identify advanced heart failure patients at high risk of mortality. These patients could potentially benefit from earlier intervention with a HeartMate 3 left ventricular assist device (LVAD). According to Jennifer Cowger, MD, co-principal investigator of the trial, this proactive approach targets patients earlier in their disease progression.
Emphasis on Patient Education and Consent
TEAM-HF distinguishes itself through its focus on patients early in their disease progression, described by Dr. Cowger as "ambulatory walkie-talkie" patients. This necessitates a strong emphasis on patient education and consent. Patients undergo thorough training on the trial's purpose, LVADs, and expected outcomes. Research coordinators conduct formal screenings and provide in-depth education on the trial's risks and benefits.
"In this trial, the term 'informed consent' becomes omnipresent, and is probably more important than many of the consents I've ever done," Dr. Cowger noted. The ongoing nature of education and consent ensures patients remain comfortable and aware throughout the trial. To mitigate bias, education is provided by VAD or research coordinators and nurses, in addition to the principal investigator.
Minimizing Patient Burden
An important aspect of the TEAM-HF trial is its effort to minimize the burden on participants. Follow-up visits largely align with the standard of care, reducing the need for additional, unnecessary appointments. "I think that's important for patients to hear these days considering there are many trials in which we're adding on unnecessary visits," Cowger stated.
Addressing Trial Complexity
When asked about the increasing complexity of clinical trials, Dr. Cowger acknowledged the need for thoroughness, especially in high-risk trials involving surgical interventions. "TEAM-HF is a trial with less-ill patients that requires a surgical intervention. So, there’s no cutting corners... it is necessary we 'dot the I’s and cross the T's' in trials that are a high enough clinical risk." While some lower-risk, non-device trials may allow for streamlining, trials like TEAM-HF demand a comprehensive approach.
