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.
| Condition(s) | Heart Failure |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 21 Years to 85 Years |
| Sex | All |
| Lead sponsor | Baylor Research Institute |
| Locations | Plano, Texas, United States |
| Start date | 2026-05-08 |
| NCT ID | NCT07096544 |
| Official listing | https://clinicaltrials.gov/study/NCT07096544 |