CALM Study: Cardiomems Assisted Lvad Management
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Baylor Research Institute
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Heart failure related (HFR) hospitalizations
Study Overview
Brief 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.
Detailed 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.
Secondary objectives:
- Number of emergency department visits
- Days alive outside the hospital
- Rate of all cause rehospitalizations
- Change in NYHA functional class
- Impact on quality of life as determined by utilizing the Kansas City Cardiomyopathy Questionnaire (KCCQ).
- Impact on functional status as determined by a six-minute walk test
- Rate of LVAD and CardioMEMS device malfunctions
- Change in baseline pulmonary pressures
- Rate and method of mortality
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 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
Arms & Interventions
Intervention Group: CardioMEMS Device
For patients randomized to the intervention group, the 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.
Intervention: CardioMEMS Device (Device)
Control Group: Standard of Care Monitoring
Patients in the control group will be monitored according to standard of care, which includes periodic evaluations of echocardiographic parameters (e.g., left ventricular size and function, aortic and mitral valve function, and right ventricular function), clinical assessments (e.g., NYHA classification, medication review, and physical examination), quality of life assessments using the Kansas City Cardiomyopathy Questionnaire (KCCQ), functional status evaluations with a six-minute walk test, and monitoring for adverse events such as heart failure-related hospitalizations, reoperations, and device-related complications.
Outcomes
Primary Outcomes
Heart failure related (HFR) hospitalizations
Time Frame: Through 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.
Heart failure related (HFR) hospitalizations
Time Frame: Through 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.
Secondary Outcomes
- Emergency Visits(Through study completion, an average of 1 year)
- Emergency Visits(Through study completion, an average of 1 year)
- Days alive outside the hospital(Through study completion, an average of 1 year)
- Days alive outside the hospital(Through study completion, an average of 1 year)