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CALM Study: Cardiomems Assisted Lvad Management

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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

Study sites (1)

TX