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CardioMEMS HF System Post Approval Study

COVID-19 update:

In response to the COVID pandemic, Scripps Health has temporarily suspended enrollment for all clinical trials. Exceptions will exist for trials with curative intent, life-saving treatment or when no standard of care exists. For questions, please call Scripps Office for the Protection of Research Subjects at 858-678-6402.

Trial ID:
Thomas Heywood
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.

Inclusion Criteria:

  • Diagnosis of NYHA class III heart failure
  • At least 1 heart failure hospitalization within previous 12 months
  • 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
  • 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.
  • Pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the right heart catheterization)

Exclusion Criteria:

  • Active infection
  • History of recurrent (> 1) pulmonary embolism or deep vein thrombosis
  • Inability to tolerate a right heart catheterization
  • A major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within previous 2 months
  • Cardiac resynchronization device (CRT) implanted within previous 3 months
  • Glomerular Filtration Rate (GFR) < 25 ml/min (obtained within 2 weeks of implant) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
  • Congenital heart disease or mechanical right heart valve
  • Likely to undergo heart transplantation or VAD within the next 6 months
  • Known coagulation disorders
  • Hypersensitivity or allergy to aspirin, and/or clopidogrel

Why isn't this trial accepting new patients?

The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting

How else can Scripps help me?

We have a broad range of physician expertise and specialized medical services available. You can find a doctor online, call 1-800-SCRIPPS (1-800-727-4777) for personal help, or see related Scripps services.

How can I find trials that are accepting new participants?

For more information, see a list of trials that are recruiting, or call the clinical research office at 858-648-6402 for help.