CardioMEMS European Monitoring Study for Heart Failure

Completed

• Conditions: decompensation; Heat failure; 10019280

• Registration Number: NL-OMON45748
• Lead Sponsor: St. Jude Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 35

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

* 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified