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CALM Study: Cardiomems Assisted Lvad Management
Sponsor: Baylor Research Institute
Summary
This prospective, open label, randomized, single-center pilot clinical trial will determine if the rate of heart failure related (HFR) hospitalizations is less in LVAD patients whose PAP is monitored with the CardioMEMS device vs the control patients receiving standard of care treatment.
Key Details
Gender
All
Age Range
21 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-03-01
Completion Date
2027-09-01
Last Updated
2026-01-13
Healthy Volunteers
No
Conditions
Interventions
CardioMEMS Device
The CardioMEMS device will be implanted during a right heart catheterization procedure. The device will be positioned in the pulmonary artery and calibrated using a Swan-Ganz catheter. After implantation, PAP measurements will be taken daily using the home monitoring system provided to the patient. These readings will be transmitted wirelessly to the clinical team, who will review the data at least once per week. Adjustments to the patient's medical therapy and LVAD speed settings will be made based on the hemodynamic data provided by the CardioMEMS device.
Locations (1)
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, United States