Status:
COMPLETED
Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief 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 an...
Detailed Description
The study is an observational, single group study where all participants receive the same intervention. The study plans to enroll up to 100 patients at 25 US sites. All patients will have a HeartMate ...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
August 24 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT03247829
Start Date
August 24 2017
End Date
June 30 2020
Last Update
April 26 2024
Active Locations (23)
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1
Scripps Health
La Jolla, California, United States, 92037
2
USC University Hospital
Los Angeles, California, United States, 90033
3
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
4
San Diego Cardiac
San Diego, California, United States, 92123