Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-04 @ 2:53 AM
Study NCT ID:
NCT05405504
Status:
UNKNOWN
Last Update Posted:
2022-06-14
First Post:
2022-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of ReDS Pro System V2.7 and ReDS ICU in Patients With Heart Failure
Sponsor:
Christian Hassager
Organization:
Study Overview
Official Title:
Evaluation of ReDS Pro System V2.7 and ReDS ICU in Patients With Heart Failure
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: