Alleviant ALLAY-HF Study
Purpose
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.
Condition
- Heart Failure
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- Advanced heart failure 2. Presence of a pacemaker 3. Evidence of right heart dysfunction
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment |
Subjects randomized to the treatment arm will undergo cardiac imaging, femoral vein access and receive the Alleviant ALV1 System device procedure. |
|
|
Sham Comparator Control |
Subjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein. |
|
Recruiting Locations
Boston Medical Center
Boston, Massachusetts 02118
Boston, Massachusetts 02118
More Details
- Status
- Recruiting
- Sponsor
- Alleviant Medical, Inc.