Research Study: Alleviant ALLAY-HF Study
Condition:
Heart Failure
Study Sponsor:
Alleviant Medical, Inc.
Study Investigator:
Dr. Peter Eckman
Study Contact:
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:
Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.
Eligibility Criteria:
Inclusion Criteria:
- Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
- NYHA Class II, III or ambulatory IV
-
Exercise right heart catheterization*
- Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
- Exercise PVR < 1.8 WU
- Ongoing stable GDMT
Exclusion Criteria:
- Advanced heart failure
- Presence of a pacemaker
- Evidence of right heart dysfunction
