CALM Study: Cardiomems Assisted Lvad Management

NCT ID: NCT07096544

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2027-09-01

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

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Group: CardioMEMS Device

For patients randomized to the intervention group, the CardioMEMS device will be implanted during a right heart catheterization procedure. The device will be positioned in the pulmonary artery and calibrated using a Swan-Ganz catheter. After implantation, PAP measurements will be taken daily using the home monitoring system provided to the patient. These readings will be transmitted wirelessly to the clinical team, who will review the data at least once per week. Adjustments to the patient's medical therapy and LVAD speed settings will be made based on the hemodynamic data provided by the CardioMEMS device.

Group Type: EXPERIMENTAL

CardioMEMS Device

Intervention Type: DEVICE

The CardioMEMS device will be implanted during a right heart catheterization procedure. The device will be positioned in the pulmonary artery and calibrated using a Swan-Ganz catheter. After implantation, PAP measurements will be taken daily using the home monitoring system provided to the patient. These readings will be transmitted wirelessly to the clinical team, who will review the data at least once per week. Adjustments to the patient's medical therapy and LVAD speed settings will be made based on the hemodynamic data provided by the CardioMEMS device.

Control Group: Standard of Care Monitoring

Patients in the control group will be monitored according to standard of care, which includes periodic evaluations of echocardiographic parameters (e.g., left ventricular size and function, aortic and mitral valve function, and right ventricular function), clinical assessments (e.g., NYHA classification, medication review, and physical examination), quality of life assessments using the Kansas City Cardiomyopathy Questionnaire (KCCQ), functional status evaluations with a six-minute walk test, and monitoring for adverse events such as heart failure-related hospitalizations, reoperations, and device-related complications.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CardioMEMS Device

The CardioMEMS device will be implanted during a right heart catheterization procedure. The device will be positioned in the pulmonary artery and calibrated using a Swan-Ganz catheter. After implantation, PAP measurements will be taken daily using the home monitoring system provided to the patient. These readings will be transmitted wirelessly to the clinical team, who will review the data at least once per week. Adjustments to the patient's medical therapy and LVAD speed settings will be made based on the hemodynamic data provided by the CardioMEMS device.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, United States

Countries

United States

Central Contacts

Bonnie Ostergren

Role: CONTACT

Bonnie.Ostergren@bswhealth.org

469-814-4181

Facility Contacts

Bonnie Ostergren

Role: primary

Bonnie.Ostergren@bswhealth.org

469-814-4181

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Im WB, Christensen HN, Sportes B. Amino acid stimulation of ATP cleavage by two Ehrlich cell membrane preparations in the presence of ouabain. Biochim Biophys Acta. 1976 Jun 17;436(2):424-37. doi: 10.1016/0005-2736(76)90205-4.

Reference Type: BACKGROUND

PMID: 6067 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 15767 (View on PubMed)

Other Identifiers

025-422

Identifier Type: -

Identifier Source: org_study_id