NCT07096544

CALM Study: Cardiomems Assisted Lvad Management

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 determined by a six-minute walk test * Rate of LVAD and CardioMEMS device malfunctions * Change in baseline pulmonary pressures * Rate and method of mortality

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-03-01
• Completion: 2027-09-01
• First posted: 2025-07-31
• Last updated: 2026-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study