Endotronix Receives IDE Approval for the Market Expanding PROACTIVE-HF 2 Clinical Trial USA - English USA - Français USA - Deutsch USA - español USA - English
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* The PROACTIVE ~ Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), has received Investigational Device Exemption (IDE) approval from the FDA for a subsequent multicenter study, PROACTIVE-HF 2. 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 PROACTIVE-HF 2 trial will evaluate the company's Cordella Sensor for pulmonary artery (PA) pressure-guided therapy. The randomized arm of the study will compare PA pressure-guided therapy to a telehealth control arm 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.

Lynne W. Stevenson M.D., Heart Failure Specialist at Vanderbilt University Medical Center in Nashville, TN, and Global Principal Investigator (PI) of the PROACTIVE-HF 2 clinical trial stated: "The evidence in favor 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."

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The Company presented 12-month sub-study data from its initial pivotal PROACTIVE-HF trial at the HFSA conference which demonstrated a low HF hospitalization rate of 0.34 at 12 months in NYHA class III HF patients. In December 2021, the prospective multi-center pivotal PROACTIVE-HF trial was redesigned from a randomized controlled trial with patients and providers in a control arm blinded to PA pressure values to a single arm study where both groups had access to patient data. The data for 63 former control arm patients was evaluated before and during the 12 month period following unblinding which demonstrated significant improvements in mean PA pressure (mPAP) and outcomes as well as strong patient interest in having access to PA pressure data.

The PROACTIVE-HF 2 clinical trial is expected to enroll up 1,500 patients in both U.S. and Europe with first patient enrollment later this year. Endotronix plans on sharing full results from their pivotal PROACTIVE-HF trial next year which could provide guidance on how best scale effective remote HF management with patient engagement while also assessing safety and efficacy of PA pressure guided therapy using Cordella Sensor in NYHA class II patients at risk for congestion

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