Key result
Redesigned single-arm PROACTIVE-HF trial evaluates Cordella PAP sensor safety and effectiveness in NYHA class III HF.
Why the study?
Optimizing GDMT and monitoring congestion are key in HF, and a PAP-guided HF management system integrating vital signs and symptoms may offer new insights into patient engagement, remote GDMT titration, and congestion management.
Does the Cordella PAP Sensor and Heart Failure System improve safety and effectiveness endpoints in patients with NYHA class III heart failure?
Population
Patients with HF and NYHA functional class III symptoms
Comparison
Cordella PAP Sensor and Cordella HF System single-arm evaluation
Design
Prospective multicenter single-arm trial
Authors
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Single-arm redesign of PROACTIVE-HF precludes causal efficacy claims; leaves open Cordella PAP Sensor role in NYHA III HF pending randomized data.
RCT
Single-blind
Yes
Does the Cordella PAP Sensor and Heart Failure System improve safety and effectiveness endpoints in patients with NYHA class III heart failure?
The PROACTIVE-HF trial is designed to evaluate the safety and effectiveness of the Cordella PAP Sensor in a single-arm study for patients with NYHA class III heart failure.
Guichard et al. (2022) conducted an RCT in Heart failure. Cordella Pulmonary Artery Sensor and Cordella Heart Failure System vs. Standard-of-care was evaluated on Safety and effectiveness. The PROACTIVE-HF trial was redesigned as a single-arm study to evaluate the safety and effectiveness of the Cordella PAP Sensor in patients with NYHA class III heart failure.
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