Heart Failure
Conditions
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
Interventions
DEVICECardioMEMS Device
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.
Sponsors
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart failure related (HFR) hospitalizations | 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
| Measure | Time frame | Description |
|---|---|---|
| Emergency Visits | Through study completion, an average of 1 year | Number of emergency department visits |
| Days alive outside the hospital | Through study completion, an average of 1 year | Days alive outside the hospital |
Countries
United States
Contacts
CONTACTBonnie Ostergren
Outcome results
None listed