CardioMEMS HF System Post Approval Study

Condition/Intervention

  • Heart failure


Study Name

CardioMEMS HF System Post Approval Study


Phase

Phase 4


Summary

The purpose of this study is to confirm the safety and effectiveness of the CardioMEMS HF System in the commercial setting for patients with heart failure. The CardioMEMS HF System, which has been approved by the U.S. Food and Drug Administration, provides a method to measure pulmonary artery pressures by using a small wireless sensor implanted into the pulmonary artery (a vessel close to the heart). Once implanted, the sensor communicates through radio frequency to an electronic unit and then transmits this valuable information to a secure website for physicians to review.

Researchers will compare data related to the use of the CardioMEMS HF System in a commercial setting with data collected in a controlled clinical setting.


Key Inclusion Criteria

  • At least 18 years of age
  • Diagnosis of New York Heart Association Class III heart failure
  • At least one heart failure hospitalization within 12 months of baseline visit
  • Written informed consent obtained from subject or legal representative


Key Exclusion Criteria

  • Active infection
  • History of recurrent pulmonary embolism or deep vein thrombosis
  • Unable to tolerate a right heart catheterization
  • Major cardiovascular event within two months of baseline visit

Please see complete list of inclusion and exclusion criteria.


Principal Investigator

Lawrence Czer, MD


Co-Investigators Include

Michele Hamilton, MD
Timothy Henry, MD
Michelle Kittleson, MD, PhD


Study Coordinator and Contact

Maria Thottam
Phone: 310-248-7136
Email: maria.thottam@cshs.org


Status

Active


IRB No.

38355


Date Last Updated

08/15