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NOT YET RECRUITING
NCT07096544
NA

CALM Study: Cardiomems Assisted Lvad Management

Sponsor: Baylor Research Institute

View on ClinicalTrials.gov

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

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.

Locations (1)

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, United States