Device for Heart failure patients with preserved Ejection fraction

Trial ID:
IRB-17-7009
Rajeev Mohan, MD
Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.

Inclusion Criteria

Patients must:

  • Have a diagnosis of Heart failure
    Have been treated with diuretics for at least 30 days
    Have ejection Fraction of over 40%
    Be over 40 years old
    Meet all other eligibility criteria

Exclusion Criteria

Patients must not:

  • Have had a major heart procedure in last 3- 12 months
    Be unable to walk
    Be on the cardiac transplant waiting list
    Have had a stroke, transient ischemic attack, deep vein thrombosis, or pulmonary emboli within the past 6 months
    Meet any other exclusion criteria

Additional Info

The Corvia shunt is designed to be permanently implanted in the atrial septum to allow left to right flow between the left atrium and right atrium to reduce the elevated left atrial pressure.

Patients will be randomized, like the flip of a coin, to get the Corvia device or a sham (no device) procedure. Patients that are randomized to the “sham” group may have the option to cross over and get the Corvia device after 24 months.

Contact Info:

  • Heather Catchpole
  • catchpole.heather@scrippshealth.org
  • 858-824-4248

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

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