NCT06944405

Implementation for Heart Failure Therapies Post-discharge Followed by CardiOSIgnal at HOME

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Precordior Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

CardioSignal technology (mechanocardiography) could enable home follow-up after admission for acute heart failure, thus improving guidline-directed medical therapies for heart failure dose escalation while reducing the logistical constraints and stress associated with frequent hospital visits. The intended purpose is to detect signs of HF in adults (aged 18 years or older and \< 85 years)

Detailed description

CardioSignal is a smartphone-based innovation using the smartphone's built-in motion sensors (accelerometer and gyroscope) for measuring heart mechanical motion (seismocardiography and gyrocardiography) when placing the phone on the chest for one minute. Innovation also includes cloud-based data analysis for heart motion signals. CardioSignal is a class IIa medical device (software as a medical device) for detecting atrial fibrillation (Afib) and measuring heart rate and soon detecting heart failure. CardioSignal provides accurate and actionable insights of heart health without the need for additional hardware for everyone and everywhere using their smartphone. Relevant disease areas include atrial fibrillation, heart failure, and related conditions such as stroke and transient ischemic attack (TIA). The innovation supports long-term monitoring and prevention efforts for high-risk populations, including patients with hypertension, diabetes, sleep apnea, cancer, and those with a history of cardiovascular disease as well as patients discharged after a surgical operation. The primary user groups are patients at home and healthcare providers at point-of-care. CardioSignal empowers patients to self-monitor heart health easily and affordably, enabling proactive care and improved outcomes across diverse populations, including elderly patients, chronic disease sufferers, and those awaiting specialist care or surgical procedures.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Mechanocardiography	Using mechanocardiography for the detection of signs of heart failure.

Timeline

• Start date: 2025-05-10
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2025-04-25
• Last updated: 2025-04-25

Locations

2 sites across 1 country: Tunisia