CardioMEMS-assisted LVAD management in heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open-label, randomized, single-center pilot trial evaluating CardioMEMS-guided management for adults with an LVAD. Participants will be randomly assigned to monitor pulmonary artery pressures with CardioMEMS versus receiving standard treatment. The study looks at heart failure–related hospitalizations as the primary outcome and also measures ED visits, days alive outside the hospital, total rehospitalizations, NYHA class, quality of life via the KCCQ, functional status via a six-minute walk, device malfunctions, changes in pulmonary pressures, and mortality. Eligible participants are adults 21–85 with a functioning HeartMate III LVAD and ability to consent and complete assessments. Exclusions include active infection, liver or kidney failure, active cancer, prior major CV events recently, and other conditions that limit participation.

Why it matters

Who can join: the full rules

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's running

• Baylor Scott & White The Heart Hospital - Plano
  Plano, Texas, United States Recruiting

Study contacts

• Study coordinator: Bonnie Ostergren
• Email: Bonnie.Ostergren@bswhealth.org
• Phone: 469-814-4181

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.