CALM Study: CardioMEMS Assisted LVAD Management
This study is looking at whether using a CardioMEMS device can help reduce hospital stays for people with heart failure who have a HeartMate III Left Ventricular Assist Device (LVAD) implanted. The CardioMEMS device is a small sensor placed in your pulmonary artery (a blood vessel in your lungs) that measures pressures daily from home. Researchers want to see if monitoring these pressures helps keep patients out of the hospital compared to standard care. You may be able to join if you are between 21 and 85 years old, have a working HeartMate III LVAD, and are stable enough to go home. The main goal is to see if fewer heart failure-related hospitalizations occur over about one year.
- Study design
- This is a single-center pilot study that will randomly assign 40 participants to either receive the CardioMEMS device or standard care. It is an open-label study, meaning both you and your doctors will know which treatment you are receiving.
- What's involved
- If you participate, you would have the CardioMEMS device implanted during a right heart catheterization procedure. After implantation, you would take daily pulmonary artery pressure measurements using a home monitoring system.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, heart failure-related hospitalizations, will be measured through study completion, which is an average of one year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CALM Study: Cardiomems Assisted Lvad Management
At a glance
Conditions
NCT07096544
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Baylor Scott & White The Heart Hospital - Plano
Plano, Texasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Heart failure related (HFR) hospitalizationsThrough 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.