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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
CardioMEMS Device
DeviceThe 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Intervention Group: CardioMEMS DeviceExperimental treatment 1 intervention
Group B: Control Group: Standard of Care MonitoringNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Heart failure related (HFR) hospitalizations
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.
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
Emergency Visits
Number of emergency department visits
Time frame
Through study completion, an average of 1 year2
Days alive outside the hospital
Days alive outside the hospital
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov