CALM Study: Cardiomems Assisted Lvad Management

NCT07096544 | Recruiting FDA Device

• 1 other identifier: 025-422
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Heart failure related (HFR) hospitalizations

  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.

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Emergency Visits

  Through study completion, an average of 1 year

• Days alive outside the hospital

  Through study completion, an average of 1 year

Study Arms (2)

Intervention Group: CardioMEMS Device

EXPERIMENTAL

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.

Device: CardioMEMS Device

Control Group: Standard of Care Monitoring

NO INTERVENTION

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.

Interventions

CardioMEMS Device 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 Group: CardioMEMS Device

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, 75093, United States

RECRUITING

Related Publications (4)

• Leff JP. Assessment of drugs in schizophrenia. Br J Clin Pharmacol. 1976 Feb;3(1 Suppl 1):75-8. doi: 10.1111/j.1365-2125.1976.tb03718.x. No abstract available.

  PMID: 9960 BACKGROUND

• Hamar J, Ligeti L, Kovach AG. Intestinal O2 consumption under low flow conditions in anaesthetized cats. Adv Exp Med Biol. 1977 Jul 4-7;94:573-8. doi: 10.1007/978-1-4684-8890-6_77. No abstract available.

  PMID: 26184 BACKGROUND

• 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.

  PMID: 6067 BACKGROUND

• Collins MW, French MR, Hirom PC, Idle JR, Bassir O, Williams RT. The conjugation of benzoic acid in the African bat, Epomops franqueti. Comp Biochem Physiol C Comp Pharmacol. 1977;56(2):103-4. doi: 10.1016/0306-4492(77)90021-1. No abstract available.

  PMID: 15767 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Bonnie Ostergren

CONTACT

469-814-4181; Bonnie.Ostergren@bswhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 31, 2025
• Study Start: May 8, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-06

Locations

US (1)