Transcatheter Atrial Shunt for Heart Failure (ALT-FLOW US Trial)

Recruiting in Palo Alto (17 mi)

+17 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Edwards Lifesciences

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a new device to help patients with heart problems by creating a small passageway between the upper chambers of their heart. This can make it easier for blood to flow and reduce the heart's workload. Since the initial description of a device for heart issues in the mid-1970s by King and Mills, a number of devices have been developed.

Eligibility Criteria

This trial is for adults over 18 with chronic heart failure who are on stable heart medication and can attend follow-ups for up to 5 years. It's not for those with severe heart issues, valve diseases, certain cardiomyopathies, renal insufficiency, metal allergies, or life expectancy less than a year due to non-heart conditions.

Inclusion Criteria

I have been diagnosed with chronic heart failure.

My pulmonary hypertension improved with a specific test.

I am 18 years old or older.

Exclusion Criteria

My body or any device in it is not suitable for the Edwards heart shunt system.

My heart's right side is not working properly.

My kidneys are not working properly.

I cannot take certain blood thinners or have a bleeding disorder.

I am under legal guardianship.

I have had a stroke, TIA, or started cardiac therapy in the last 6 months.

I have not had unstable blood pressure or heart issues in the last 30 days.

I do not have severe heart failure.

I have been diagnosed with a specific type of heart muscle disease.

I can walk less than 50 meters or more than 600 meters in 6 minutes.

My heart's right side is not working properly.

My liver is not working well.

Participant Groups

The study tests the Edwards Transcatheter Atrial Shunt System's safety and effectiveness in patients with heart failure. The device aims to relieve symptoms by creating a small passage between the left and right atria of the heart.

1Treatment groups

Experimental Treatment

Group I: Edwards Transcatheter Atrial Shunt SystemExperimental Treatment1 Intervention