Endotronix Secures IDE Approval for the Expansion of the PROACTIVE-HF 2 Clinical Trial
Tuesday, October 10, 2023
Endotronix, Inc., a leading digital health and medical technology company focused on advancing heart failure (HF) treatment, has recently obtained FDA approval for Investigational Device Exemption (IDE) for its upcoming multicenter study, PROACTIVE-HF 2. This study will evaluate the effectiveness of the Cordella Sensor in guiding therapy based on pulmonary artery (PA) pressure.
PROACTIVE-HF 2 encompasses two arms and is designed to extend its scope to include New York Heart Association (NYHA) class II HF patients. It seeks to enable efficient and scalable remote patient management through a combination of clinician-directed care and patient self-management.
In the randomized arm of PROACTIVE-HF 2, it represents the inaugural attempt to compare PA pressure-guided therapy with a telehealth-based control arm. Meanwhile, the single-arm cohort focuses on comprehending the impact of engaged patients on outcomes. These parallel studies offer valuable insights into the long-term effects of pulmonary hypertension on right ventricular function and provide guidance on expanding this crucial therapy while promoting patient involvement.
The PROACTIVE-HF 2 trial, an open-label, prospective, randomized controlled clinical trial, aims to enroll up to 1,500 patients in the United States and Europe. Remarkably, this pivotal multi-center trial has transitioned from a randomized controlled trial where both patients and providers in the control arm were unaware of PA pressure values to a single-arm study where both groups have access to patient data.