CALM Study: CardioMEMS Assisted LVAD Management

This study is looking at whether using a CardioMEMS device can help reduce hospital stays for people with heart failure who have a HeartMate III Left Ventricular Assist Device (LVAD) implanted. The CardioMEMS device is a small sensor placed in your pulmonary artery (a blood vessel in your lungs) that measures pressures daily from home. Researchers want to see if monitoring these pressures helps keep patients out of the hospital compared to standard care. You may be able to join if you are between 21 and 85 years old, have a working HeartMate III LVAD, and are stable enough to go home. The main goal is to see if fewer heart failure-related hospitalizations occur over about one year.

Study design
This is a single-center pilot study that will randomly assign 40 participants to either receive the CardioMEMS device or standard care. It is an open-label study, meaning both you and your doctors will know which treatment you are receiving.
What's involved
If you participate, you would have the CardioMEMS device implanted during a right heart catheterization procedure. After implantation, you would take daily pulmonary artery pressure measurements using a home monitoring system.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, heart failure-related hospitalizations, will be measured through study completion, which is an average of one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07096544

CALM Study: Cardiomems Assisted Lvad Management

Recruiting
NAAges 21–85InterventionalSupportive care
Baylor Research Institute
~40 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:CardioMEMS Device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Heart failure related (HFR) hospitalizations
Measured over Through study completion, an average of 1 year
Heart Failure

NCT07096544

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baylor Scott & White The Heart Hospital - Plano

    Plano, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

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

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
  • Heart failure related (HFR) hospitalizationsThrough 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.