RecruitingNot ApplicableNCT07096544

CALM Study: Cardiomems Assisted Lvad Management

Sponsor

Baylor Research Institute

Enrollment

40 participants

Start Date

May 8, 2026

Study Type

INTERVENTIONAL

Conditions

Heart Failure

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

Min Age: 21 YearsMax Age: 85 Years

Inclusion Criteria6

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
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 Criteria15

Current/ongoing fevers or constitutional symptoms
Bilirubin greater than 2.5µmol/L, shock liver, or biopsy-proven liver cirrhosis
Requiring dialysis or declared end stage renal disease
Inability to complete written informed consent or a quality-of-life questionnaire
Known active malignancy
History of recurrent (> 1) pulmonary embolism or deep vein thrombosis
Unable to tolerate a right heart catheterization
Major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of CardioMEMS implant
Glomerular Filtration Rate (GFR) <25 ml/min who are non-responsive to diuretic therapy
Patients likely to undergo heart transplantation within 6 months of Screening Visit
Congenital heart disease or mechanical right heart valve(s)
Known coagulation disorders
Hypersensitivity or allergy to aspirin, and/or clopidogrel
Pregnant or considering pregnancy
Required RV assist device and has severe right heart failure post LVAD implantation

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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.