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Registry of Patients With CardioMEMS

NCT02729922 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-09-10

No results posted yet for this study

Summary

CardioMEMS is an implantable wireless hemodynamic monitoring system which can transmit the pulmonary artery pressure. This device is FDA approved to be used as a diagnostic tool to help management of selected heart failure patients. Heart failure patients with NYHA class III heart failure, irrespective of the left ventricular ejection fraction, and a previous hospital admission for heart failure in the past 12 months, without stage IV or V chronic kidney disease are candidates to receive a CardioMEMS device. Our goal is to create a registry of all patients that receive a CardioMEMS device and monitor outcomes, primarily heart failure hospitalizations, heart failure related quality of life and re-admissions.

Conditions

  • Heart Failure, Congestive

Interventions

DEVICE

Cardiomems

Eligible patients will undergo implantation of a pulmonary artery sensor (CardioMEMS), a wireless implantable hemodynamic monitoring system in the cardiac catheterization laboratory. This system has a passive wireless, radiofrequency sensor without batteries or leads. Patients transmit data through a device in their home that interacts wirelessly with the sensor. Clinicians retrieve this data via a web interface to use in making management decisions for patients.

Sponsors & Collaborators

Principal Investigators

  • Lee R Goldberg, MD, MPH · University of Pennsylvania

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02729922 on ClinicalTrials.gov