Health Condition 1: null- Congestive Heart Failure (CHF)
Conditions
Interventions
Intervention1: Investigational non invasive monitoring device: Not Applicable
Control Intervention1: Nil: Nil
Sponsors
Corventis Inc
Eligibility
Inclusion criteria
Inclusion criteria: Potential patients must meet all of the following criteria: 1. Is female or male, 18 years of age or older 2. Has an ejection fraction of 40% reported within 12 months of enrollment 3. Have acute decompensated heart failure and receiving treatment for fluid overload 4. Is willing to provide written informed consent and comply with study guidelines
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria 1. Has an implantable device with an active minute ventilation sensor 2. Has a known allergy or hypersensitivity to adhesives or hydrogel 3. Has received the first treatment for this episode of acute heart failure decompensation more than 24 hours ago 4. Is participating in another clinical study that may confound the results of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To gather data to correlate physiological signals with the patient?s fluid status and heart failure symptoms during recovery from acute heart failure decompensation.Timepoint: Analyses in addition to the primary endpoint analysis will include: ii) Summarizing the incidence and frequency of all adverse events reported during the study. Events will be classified by the study sites into adverse events, serious adverse events (SAEs), and/or unanticipated adverse device effects (UADEs). Severity of each event will be classified as mild, moderate or severe. The relationship to the investigational device will be determined using a classification of Definite, Probable, Possible or None. The number and percent of patients experiencing each event will be presented with the number and percent of the following: SAE, UADE, moderate events, severe events, definitely related events, probably related events and possibly related events. | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
Max Neeman Medical International
Outcome results
None listed