ALLAY-HF

Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure

Objective

The objective of this study is to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.

Study Arms

• Experimental: Treatment; cardiac imaging, femoral vein access receiving the Alleviant ALV1 System device procedure
• Sham Comparator: Control; cardiac imaging and sheath placement in femoral vein

Eligibility

1. Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
2. NYHA Class II, III or ambulatory IV
3. Exercise right heart catheterization*
   1. Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
   2. Exercise PVR < 1.8 WU
4. Ongoing stable GDMT

NCT ID

NCT05685303