NCT07096544 CALM Study: Cardiomems Assisted Lvad Management
| NCT ID | NCT07096544 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baylor Research Institute |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-05-08 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-05-08 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07096544 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 85 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07096544 currently recruiting?
Yes, NCT07096544 is actively recruiting participants. Contact the research team at Bonnie.Ostergren@bswhealth.org for enrollment information.
Where is the NCT07096544 trial being conducted?
This trial is being conducted at Plano, United States.
Who is sponsoring the NCT07096544 clinical trial?
NCT07096544 is sponsored by Baylor Research Institute. The trial plans to enroll 40 participants.
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