decompensation Heat failure
Conditions
Interventions
Implantation of CardioMEMS sensor
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Indicated to receive a CardioMEMS sensor implant per the CardioMEMS* HF System User*s Manual o > 18 years of age o Diagnosis of NYHA Class III Heart Failure at the time of sensor implantation o Hospitalization for worsening HF within 12 months prior to the CardioMEMS HF System implant. For the purposes of this study, a HF hospitalization is defined as an overnight stay in the hospital with signs and symptoms of congestion requiring intensification of treatment for HF o Subjects with reduced Left Ventricular Ejection Fraction (LVEF) must be on stable Guideline Directed Medical Therapy (GDMT) as tolerated o Written informed consent obtained from subject
Exclusion criteria
Exclusion criteria: * Known coagulation disorders or inability to take two types of blood thinning medications for one month after the sensor is implanted * Subjects deemed a candidate for transplant, Ventricular Assist Device, or hospice care in the next 12 months or are otherwise not expected to be able to complete the study follow up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoints: The primary safety endpoints are freedom from device/system related complications (Serious Adverse Device Effects) and freedom from pressure sensor failure at 12 months post-implant. * A device/system related complication (Serious Adverse Device Effects) is an adverse event that is, or is possibly, related to the device/system (wireless pressure sensor or external electronics) and has at least one of the following characteristics: o is treated with invasive means (other than intramuscular medication or right heart catheterization which is used for diagnostic purposes) o results in death of the subject o results in the explant of the device * A pressure sensor failure occurs when no readings can be obtained after troubleshooting the system to rule out any problems with the external electronics. Primary Clinical Performance Endpoint: The primary clinical performance endpoint is patient data transmission success at 12 months post implant. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is the annualized HF hospitalization rate at 12 months compared to the annualized HF hospitalization rate for the 12 months prior to implant. | — |
Countries
Netherlands
Outcome results
None listed