N/A
Completed N=234
CardioMEMS European Monitoring Study for Heart Failure
Source: ClinicalTrials.gov NCT02693691 ↗Enrolled (actual)
234
Serious AEs
77.0%
Results posted
Aug 2020
Primary outcomePrimary: Freedom From Device/System Related Complications — 98.3 percentage of patients
Summary
The purpose of this study is to characterize the use of the CardioMEMS™ HF System when used in a real-world setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Device/System Related Complications |
98.3 | — |
| PRIMARY Freedom From Pressure Sensor Failure |
99.6 | — |
| PRIMARY Percent of Successful Pulmonary Artery Pressure Data Transmissions |
91.7 | — |
| SECONDARY Heart Failure Hospitalization (HFH) Rate |
0.38 | — |
Eligibility Criteria
Inclusion Criteria
- Indicated to receive a CardioMEMS sensor implant per the CardioMEMS™ HF System User's Manual
- ≥ 18 years of age
- Diagnosis of New York Heart Association (NYHA) Class III Heart Failure at the time of sensor implantation
- Hospitalization for worsening HF, as defined in the protocol, within 12 months prior to the CardioMEMS HF System implant
- Subjects with reduced Left Ventricular Ejection Fraction (LVEF) must be on stable Guideline Directed Medical Therapy (GDMT) as tolerated
- 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
Data sourced from ClinicalTrials.gov (NCT02693691). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.