Endotronix has obtained investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for the subsequent multicentre study to evaluate the Cordella Sensor for pulmonary artery (PA) pressure-guided therapy.
Known as PROACTIVE-HF 2, the dual-arm prospective study intends to expand access to New York Heart Association (NYHA) class II HF patients.
With a clinician-directed patient self-management strategy, the trial will also support scalable remote patient management.
The open-label, randomised, controlled clinical trial will enrol up to 1,500 patients in Europe and the US.
The design of the dual arm study has been revealed at HFSA and the first patient is anticipated to be enrolled later this year.
Using Cordella in NYHA class II patients who are at risk for congestion, the randomised arm will evaluate the efficacy and safety of PA pressure-guided therapy.
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Clinicians and patients can access daily trended telehealth data, including weight, heart rate and blood pressure, in both cohorts. The treatment cohort can also access daily PA pressure data.
The PROACTIVE-HF 2 trial will use a compositive first HF event or death rate and evaluate efficacy and safety for up to 24 months.
The single-arm trial will evaluate clinician-directed patient self-management impact at home in NYHA class III HF patients at risk for poor outcomes using a 12-month endpoint for incidence and safety of hospitalisation or death.
Both arms will gather data on secondary endpoints, comprising changes in right ventricular function in relation to PA pressure as well as patient engagement.
Endotronix CEO and co-founder Harry Rowland said: “We remain confident in the benefits Cordella brings to patients and clinicians to improve heart failure outcomes and remain on track for a mid-2024 launch.”
The multi-centre, prospective PROACTIVE-HF trial was redesigned in December 2021 from a randomised controlled trial to a single-arm study.
Patients and providers in the control arm were blinded to PA pressure values and both groups had access to patient data.