NCT07096544 · Baylor Research Institute
CALM Study: Cardiomems Assisted Lvad Management
(CALM)
What this study is about
This forward-looking, open label, randomly assigned, 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 the usual treatment treatment.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Plano, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations