Tests a pressure sensor in heart failure patients with a heart pump
Tests whether a pressure sensor lowers heart failure hospital stays in people with heart pumps.
Plain-language title generated from the registry record
Registry title: CALM Study: Cardiomems Assisted Lvad Management
Key facts
- Where
- Plano, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 85 years old?
Source: NCT07096544, who can take part
Where in United States
- Baylor Scott & White The Heart Hospital - PlanoPlano, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Baylor Research Institute
- Trial code
- NCT07096544
- Record updated
- 3 June 2026
- Original 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.Read full original descriptionShow less
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.
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: Requiring dialysis or declared end stage renal disease; 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; 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; Required RV assist device and has severe right heart failure post LVAD implantation; Bilirubin greater than 2.5µmol/L, shock liver, or biopsy-proven liver cirrhosis; Glomerular Filtration Rate (GFR) <25 ml/min who are non-responsive to diuretic therapy; Current/ongoing fevers or constitutional symptoms; Inability to complete written informed consent or a quality-of-life questionnaire; Pregnant or considering pregnancy.