Device trial for patients diagnosed with left heart failure
Study ID: ALT-FLOW
This is an early feasibility study of the Edwards transcatheter atrial shunt system. This trial is for patients who have been diagnosed with symptomatic, clinically significant, left heart failure despite medical therapy. Participants will undergo close follow-up for five years.
This is a multi-center, prospective, early feasibility study of the safety and efficacy of the Edwards transcatheter atrial shunt system.
Eligible patients must have chronic symptomatic heart failure (HF) documented by the following:
- NYHA class II with a history NYHA class > II; NYHA class III; or ambulatory NYHA class IV; and at least one hospital admission for HF in the past 12 months or elevated BNP
- Elevated left atrial (or wedge) pressure
Patients must have no significant valve disease, such as mitral valve regurgitation (>3+ MR), tricuspid valve regurgitation (>2+ TR), or aortic valve disease (>2+ AR or > moderate AS). Additionally, patients must be stable on guideline-directed medical therapy for HF and expected to be maintained on such therapy without change for six months.
Other inclusion/exclusion criteria apply.
- Must have been diagnosed with significant heart failure and elevated left atrial pressure
- Must be willing to have the atrial shunt implanted in their heart
- Must be willing to undergo follow-up care for up to five years