CALM Study: Cardiomems Assisted Lvad Management
Recruiting · NCT07096544 · Interventional (participants receive a specific treatment) · Lead sponsor: Baylor Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
CardioMEMS Device
What this trial is about
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 take part
Age range
21 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Baylor Scott & White The Heart Hospital - Plano - Plano, Texas, United States