CALM Study: Cardiomems Assisted Lvad Management

Last updated: June 1, 2026
Sponsor: Baylor Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Congestive Heart Failure

Heart Failure

Treatment

CardioMEMS Device

Clinical Study ID

NCT07096544
025-422
  • Ages 21-85
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Age 21-85

  • Status post HeartMate III Left Ventricular Assist Device Implantation

  • Normally functioning left ventricular assist device as determined by deviceparameters

  • 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 thisclinical investigation

Exclusion

Exclusion Criteria:

  • 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 ofCardioMEMS implant

  • Glomerular Filtration Rate (GFR) <25 ml/min who are non-responsive to diuretictherapy

  • 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

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: CardioMEMS Device
Phase:
Study Start date:
May 08, 2026
Estimated Completion Date:
September 01, 2027

Study 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

Connect with a study center

  • Baylor Scott & White The Heart Hospital - Plano

    Plano, Texas 75093
    United States

    Active - Recruiting

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