N/A
Completed N=101
Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™
Source: ClinicalTrials.gov NCT03247829 ↗Enrolled (actual)
101
Serious AEs
35.6%
Results posted
Apr 2024
Primary outcomePrimary: Six Minute Hall Walk (6MHW) Distance — -44.9; 69.7 meters — p=0.001
Summary
This observational post market study is intended to characterize hemodynamic-guided management of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional status, quality of life, and readmissions
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Six Minute Hall Walk (6MHW) Distance |
-44.9; 69.7 | 0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Subject has CardioMEMS HF PA Sensor and a commercially-approved HeartMate LVAD (Group A) OR Subject has commercially-approved HeartMate LVAD, is experiencing NYHA class III symptoms, and has had a previous HF hospitalization and meets FDA indications for CardioMEMS. The CardioMEMS PA Sensor must be implanted within 72 hours of consent (Group B)
- Signed an informed consent form and agreed to provide access to patient and device data (including CardioMEMS Merlin.net data)
- No connectivity or transmission problems with CardioMEMS
- On HeartMate LVAD support for at least 3 months
- Age ≥ 18 years
Exclusion Criteria
- Current participation in an investigation that is likely to confound study results or affect study outcome
- Current participation in the MOMENTUM3 IDE Clinical trial and has not completed the two year follow-up for that trial
- Inability to perform 6MHW test due to conditions other than heart failure (e.g. severe arthritis, orthopedic issues, amputation etc.)
Data sourced from ClinicalTrials.gov (NCT03247829). 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.