Alleviant ALLAY-HF Study
Not Applicable
- Conditions
- Heart Failure
- Registration Number
- NCT05685303
- Lead Sponsor
- Alleviant Medical, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Inclusion Criteria:<br><br> 1. Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%<br><br> 2. NYHA Class II, III or ambulatory IV<br><br> 3. Exercise right heart catheterization*<br><br> 1. Elevated left atrial pressure during exercise right heart catheterization<br> (greater than or equal to 25 mmHg)<br><br> 2. Exercise PVR < 1.8 WU<br><br> 4. Ongoing stable GDMT<br><br>Exclusion Criteria:<br><br> 1. Advanced heart failure<br><br> 2. Presence of a pacemaker<br><br> 3. Evidence of right heart dysfunction
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite Primary Endpoint
- Secondary Outcome Measures
Name Time Method