Research Study: ALt FLOW
Condition:
heart failure
Study Sponsor: Edwards Lifesciences
Study Investigator: Paul Sorajja, MD
Study Contact: Karen Meyer, RN
karen.meyer2@allina.com
612-863-5855
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:

The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.
Eligibility Criteria:

  • Signed and dated IRB approved study consent form prior to study related procedures
  • ≥ 18 years old
  • Chronic symptomatic Heart Failure (HF) documented by the following:
    • NYHA class II with a history of NYHA class > II; NYHA class III; or ambulatory NYHA class IV AND
    • ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV) or intensification of oral diuresis for HF in a healthcare facility (emergency department/acute care facility) within the 12 months prior to study entry; OR an NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months.
  • In the judgment of the investigator, subject is on stable Guideline Directed Medical Therapy (GDMT) for heart failure and management of potential comorbidities according to current ACCF/AHA Guidelines and that is expected to be maintained without change for 3 months
  • Elevated LA (or PCWP) pressure of > 15 mmHg at rest or > 25 mmHg during supine ergometer exercise stress test, as measured at end-expiration; AND the LA (or PCWP) exceeds right atrial pressure (RAP) by > 5 mmHg at rest or > 10 mmHg during supine ergometer exercise stress test as measured at end-expiration
  • Willing to attend study follow-up assessments for up to 5 years

Interested in participating in this study?

Reach out to the study contact directly, or fill out this form and we will contact you and assess whether you are an eligible candidate!