CALM Study: Cardiomems Assisted Lvad Management

Not Applicable

Not yet recruiting

• Conditions: Heart Failure

• Registration Number: NCT07096544
• Lead Sponsor: Baylor Research Institute

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.

Detailed Description

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.

Secondary objectives:

* Number of emergency department visits

* Days alive outside the hospital

* Rate of all cause rehospitalizations

* Change in NYHA functional class

* Impact on quality of life as determined by utilizing the Kansas City Cardiomyopathy Questionnaire (KCCQ).

* Impact on functional status as determined by a six-minute walk test

* Rate of LVAD and CardioMEMS device malfunctions

* Change in baseline pulmonary pressures

* Rate and method of mortality

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-22
• Study First Submitted QC: 2025-07-24
• Study First Posted: 2025-07-31
• Last Update Submitted: 2025-08-05
• Last Update Posted: 2025-08-07
• Study Start: 2025-09-01
• Primary Completion: 2026-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Heart failure related (HFR) hospitalizations	Through 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.

Secondary Outcome Measures

Name	Time	Method
Emergency Visits	Through study completion, an average of 1 year	Number of emergency department visits
Days alive outside the hospital	Through study completion, an average of 1 year	Days alive outside the hospital

Trial Locations

Locations (1)

Baylor Scott & White The Heart Hospital - Plano; 🇺🇸 Plano, Texas, United States