Investigational device for patients with heart failure due to left heart disease

Trial ID:
IRB-24-8407
Rola Khedraki, MD

Inclusion Criteria

Patients must:

  • Be 18 or older with chronic symptomatic heart failure
    Be symptomatic according to NYHA functional class II, III, or ambulatory IV
    Meet all other inclusion criteria

Exclusion Criteria

Patients must not:

  • Have greater than moderate mitral, tricuspid, or aortic regurgitation
    Have known untreated carotid artery stenosis
    Be expected to undergo elective major surgery within 6 months
    Have a BMI >45

Additional Info

The investigational device being studied in this trial is the APTURE shunt, a metal device that is placed in the heart to create a channel allowing a small amount of blood to flow from a heart chamber with elevated pressure - the left atrium, to a heart chamber with lower pressure - the right atrium, via a blood vessel - the coronary sinus. This shunting of blood is intended to relieve the elevated pressure which can cause symptoms associated with HFmrEF and HFpEF.

Contact Info:

  • Clinical Research Services
  • CRSLeadership@scrippshealth.org