CALM Study: Cardiomems Assisted Lvad Management
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-85
SponsorBaylor Research Institute
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- CardioMEMS Device
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov