Alleviant ALLAY-HF Study
Recruiting
N/A
Interventional Study
Heart Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 40 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 700 (estimated)
- Sponsor
- Alleviant Medical, Inc. · Industry
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About This Trial
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.
Trial Locations
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Eligibility 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 …
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