N/A
N=101
Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03247829 ↗Enrolled (actual)
101
Serious AEs
35.6%
Results posted
Apr 2024
Primary outcome: Primary: Six Minute Hall Walk (6MHW) Distance — -44.9; 69.7 meters — p=0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Hemodynamic management using CardioMEMS HF System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Six Minute Hall Walk (6MHW) Distance |
-44.9; 69.7 | 0.001 sig |
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
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.