Reduce LAP-HF II

STUDY IDENTIFIER:

REDUCE LAP-HF II

CONDITION:

HFpEF

CONTACT INFO:

Jane Fox, RN   |   jane.fox@allina.com   |   612-863-6289

DESCRIPTION:

The Corvia Medical InterAtrial Shunt Device (IASD®) System II is indicated for the improvement in quality of life and reduction of heart failure related symptoms and events in patients with heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF) with elevated left atrial pressures, who remain symptomatic despite standard Guideline Directed Medical Therapy. The implant is supplied preloaded onto a delivery system consisting of a delivery catheter with an integrated handle. The implant is placed across the interatrial septum using a percutaneous trans-catheter approach. The procedure is performed in the cardiac catheterization laboratory by an interventional cardiologist. In the setting of high left atrial pressure, the center barrel section allows L→R flow to decompress the left atrium.

CRITERIA LIST/ QUALIFICATIONS:

  • > 40 years  ​NYHA class II with prior history of >NYHA II, ambulatory class IV within past 12 months AND > 1 HF hospital admission, or treatment with IV diuretics or intensification of oral diuresis for HF in a healthcare facility; or NT-pro BNP elevation (per specific guidelines)
  • Ongoing stable GDMT HF management with no significant changes
  • LV EF > 40% within past 6 months, without documented EF < 30% in the past 5 years
  • Elevated PCWP as determined during supine ergometer exercise > 25mm Hg and > RAP by > 5 mm Hg
  • Must be able to perform a 6 minute walk test
 

INVESTIGATORS:

Michael Samara, MD

SPONSORS:

Corvia Medical, Inc.

STATUS:

Hasn't started

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