HVP_CIP-10035 CardioMEMS

CardioMEMS HF System Post Approval Study

The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting.

Key Inclusion Criteria:

1. Diagnosis of NYHA class III heart failure
2. At least 1 heart failure hospitalization within previous 12 months
3. Patients with reduced LVEF heart failure should be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the patient is intolerant to beta blockers, ACE-I or ARB
4. BMI ≤ 35. Patients with BMI >35 will require their chest circumference to be measured at the axillary level. If > 65 inches the patient will not be eligible for the study.
5. Pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the right heart catheterization)

See clinicaltrials.gov for full details
N/A
NCT02279888
Heart and Vascular, All Other
Heart Failure
Jacob Abraham MD
St Jude Medical
Ellen Muir
  • Providence St. Vincent Medical Center