CALM Study: Cardiomems Assisted Lvad Management
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 85
Healthy Volunteers: f
View:
• 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
Locations
United States
Texas
Baylor Scott & White The Heart Hospital - Plano
RECRUITING
Plano
Contact Information
Primary
Bonnie Ostergren
Bonnie.Ostergren@bswhealth.org
469-814-4181
Time Frame
Start Date: 2026-05-08
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 40
Treatments
Experimental: Intervention Group: CardioMEMS Device
For patients randomized to the intervention group, 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.
No_intervention: Control Group: Standard of Care Monitoring
Patients in the control group will be monitored according to standard of care, which includes periodic evaluations of echocardiographic parameters (e.g., left ventricular size and function, aortic and mitral valve function, and right ventricular function), clinical assessments (e.g., NYHA classification, medication review, and physical examination), quality of life assessments using the Kansas City Cardiomyopathy Questionnaire (KCCQ), functional status evaluations with a six-minute walk test, and monitoring for adverse events such as heart failure-related hospitalizations, reoperations, and device-related complications.
Related Therapeutic Areas
Sponsors
Leads: Baylor Research Institute