CALM Study: Cardiomems Assisted Lvad Management

Baylor Research Institute40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

CardioMEMS DeviceDEVICE

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Through study completion, an average of 1 year

Secondary Outcomes

Emergency Visits

Number of emergency department visits

Time frame: Through study completion, an average of 1 year

Days alive outside the hospital

Time frame: Through study completion, an average of 1 year

Central Contacts

Bonnie Ostergren

CONTACT

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

Data from ClinicalTrials.gov

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