CALM Study: Cardiomems Assisted Lvad Management

Recruiting now · Not applicable

Conditions studied: Heart Failure

In brief

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 facts

Study ID

NCT07096544

Run by

Baylor Research Institute

People needed

40

Starts

2026-05-08

Expected to finish

2027-09-01

Last updated by the study team

2026-06-03

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Baylor Scott & White The Heart Hospital - Plano — Plano, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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