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NCT Number: NCT07096544

CALM Study: Cardiomems Assisted Lvad Management

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.

Recruiting

Interested in participating?

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, 75093, United States

Location status: Recruiting

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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 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

Treatment and study plan

CardioMEMS Device

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.

Primary outcomes

  1. Heart failure related (HFR) hospitalizations

    Time frame: Through study completion, an average of 1 year

    Rate of heart failure related (HFR) hospitalizations in LVAD patients whose PAP is monitored with the CardioMEMS device vs the control patients receiving standard of care treatment.

Secondary outcomes

  1. Emergency Visits

    Time frame: Through study completion, an average of 1 year

    Number of emergency department visits

  2. Days alive outside the hospital

    Time frame: Through study completion, an average of 1 year

    Days alive outside the hospital

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Acronym: CALM

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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