Endotronix has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for a subsequent multicentre study, PROACTIVE-HF 2, which will evaluate the company’s Cordella sensor for pulmonary artery (PA) pressure-guided therapy.
The prospective, dual-arm trial aims to expand access to New York Heart Association (NYHA) class II HF patients and support efficient and scalable remote patient management with a clinician-directed, patient self-management strategy.
“The evidence in favour of PA pressure-guided therapy for NYHA class III HF patients has been consistently validated over the last 15 years. However, questions remain as to the therapy benefit in NYHA class II patients and how to best scale effective remote HF management,” stated Lynne W Stevenson (Vanderbilt University Medical Center, Nashville, USA) global principal investigator (PI) of the PROACTIVE-HF 2 clinical trial. “The randomised arm of PROACTIVE-HF 2 will be the first study to compare PA pressure-guided therapy to a telehealth control arm. The single-arm cohort evaluates the power of engaged patients and subsequent impact on outcomes. Together these studies help us better understand the impact of pulmonary hypertension on right ventricular function over time and provide guidance on how to scale this important therapy with patient engagement.”
The PROACTIVE-HF 2 prospective, open-label randomised controlled clinical trial will enrol up to 1,500 patients in the USA and Europe. The dual arm study design was presented at the Heart Failure Society of America (HFSA) annual meeting (6–9 October, Cleveland, USA) and the first patient is expected to be enrolled later this year.
The randomised arm will assess the safety and efficacy of PA pressure-guided therapy using Cordella in NYHA class II patients at risk for congestion. In both cohorts, patients and clinicians will have access to daily trended telehealth data (i.e. blood pressure, heart rate, and weight) and the treatment cohort will also have access to daily PA pressure data.
The study will evaluate safety and efficacy, using a compositive first HF event or death rate, for up to 24 months. The single-arm study will assess the impact of clinician-directed patient self-management at home in NYHA class III HF patients who are at risk for poor outcomes using a 12-month endpoint for safety and incidence of HF hospitalisation or death. Both arms will collect data on secondary endpoints including changes in right ventricular function in relation to PA pressure, and patient engagement.