Recruiting

CardioMEMS

Sponsor:

Baylor Research Institute

Code:

NCT07096544

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

CardioMEMS Device

Study Details

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

Study ID

NCT07096544

Start date

May 8, 2026

Status verified date

Jun, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: 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.

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.

Primary outcome measure

  • Heart failure related (HFR) hospitalizations [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Bonnie Ostergren

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

Locations

Baylor Scott & White The Heart Hospital - Plano

Recruiting

Plano, Texas, United States, 75093

Contacts

Bonnie Ostergren

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

More Information

Sponsor

Baylor Research Institute

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor Research Institute on 2026-06-03.