NCT05405504

Evaluation of ReDS Pro System V2.7 and ReDS ICU in Patients With Heart Failure

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Christian Hassager · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is an investigator-initiated, prospective cohort trial. The trial aims to evaluate ReDS Pro System V2.7 and ReDS ICU in patients with heart failure (HF).

Detailed description

The study is an investigator-initiated, prospective cohort trial. The trial aims to evaluate ReDS Pro System V2.7 and ReDS ICU in patients with heart failure (HF). The overall purposes are: * to evaluate the ReDS efficacy measurements of lung fluid compared to pulmonary artery pressure guided therapy with CardioMEMS in out-patients with HF. * to describe the feasibility of ReDS ICU in patients admitted to an ICU with HF For the out-patient part, the patients will be recruited from the outpatient clinic at Rigshospitalet. The patient must be at least 18 years, have a history of chronic HF, and already monitored using CardioMEMS and must not fulfill any of the exclusion criteria. For the ICU part, the patients will be recruited at the ICU department at the Heart Center at Rigshospitalet. The patient must be at least 18 years, intubated, and unconscious or sedated (Glasgow Coma Score \<8), and already monitored using Swan-Ganz and arterial catherization and must not fulfill any of the exclusion criteria.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Remote Dielectric Sensing (ReDS)	Non-invasive device designed for the measurement of lung fluid using extremely low power electromagnetic waves. The ReDS Pro System V2.7 system has CE approval (3900874CE01) and FDA clearance.

Timeline

• Start date: 2022-06-13
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2022-06-06
• Last updated: 2022-06-14

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated device study