NCT07096544Recruiting
CALM Study: Cardiomems Assisted Lvad Management
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 22 Jul 2025
- Start date
- 8 May 2026
- Primary completion date
- 1 May 2027
- Lead sponsor
- Baylor Research Institute
- Diseases
- Heart failure
- NCT number
- NCT07096544
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 8 May 2026 to the primary completion date, 1 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Requiring dialysis or declared end stage renal disease
- 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
- 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
- Required RV assist device and has severe right heart failure post LVAD implantation
Lab values
- Bilirubin greater than 2.5µmol/L, shock liver, or biopsy-proven liver cirrhosis
- Glomerular Filtration Rate (GFR) \<25 ml/min who are non-responsive to diuretic therapy
Other
- Current/ongoing fevers or constitutional symptoms
- Inability to complete written informed consent or a quality-of-life questionnaire
- Pregnant or considering pregnancy
Who the study is looking for
- 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
Age in the registry: 21 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baylor Scott & White The Heart Hospital - Plano Coordinator of this site? Confirm its status | Plano | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.