Study detail
RecruitingObservational
Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure
Alleviant Medical, Inc.
Summary
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
- Age range
- 40+ years
- Sex
- All
- Healthy volunteers
- No
Detailed criteria
Inclusion Criteria: 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 Exclusion Criteria: 1. Advanced heart failure 2. Presence of a pacemaker 3. Evidence of right heart dysfunction