CALM Study: Cardiomems Assisted Lvad Management
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.
Description
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. Secondary objectives: * Number of emergency department visits * Days alive outside the hospital * Rate of all cause rehospitalizations * Change in NYHA functional class * Impact on quality of life as determined by utilizing the Kansas City Cardiomyopathy Questionnaire (KCCQ). * Impact on functional status as…
Eligibility
- Age range
- 21–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 21-85 * Status post HeartMate III Left Ventricular Assist Device Implantation * Normally functioning left ventricular assist device as determined by device parameters * Stable and ready to be discharged home * 18 years of age or older at the time of left ventricular device implantation * The patient provides written informed consent before starting any component of this clinical investigation Exclusion Criteria: * Current/ongoing fevers or constitutional symptoms * Bilirubin greater than 2.5µmol/L, shock liver, or biopsy-proven liver cirrhosis * Requiring dialysis…
Interventions
- DeviceCardioMEMS 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.
Location
- Baylor Scott & White The Heart Hospital - PlanoPlano, Texas