Alleviant ALLAY-HFrEF 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
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 350 (estimated)
- Sponsor
- Alleviant Medical, Inc. · Industry
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About This Trial
Prospective, multicenter, randomized, sham-controlled, double blind (patient and observer), study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFrEF.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* LVEF ≤ 40%
* NYHA class II, III or ambulatory IV HF
* Receiving optimal, maximally tolerated, stable GDMT
Exclusion Criteria:
* Advanced heart failure
* Life-expectancy \< 12 months
* Evidence of right heart dysfunction
Contacts