Tests a no-implant heart shunt device in adults with heart failure
Tests a heart shunt device against a sham procedure in adults with heart failure.
Plain-language title generated from the registry record
Registry title: Alleviant ALLAY-HFrEF Study
Key facts
- Where
- Christchurch and Dunedin, New ZealandSee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with heart failure and a weak heart pump (reduced ejection fraction) who are already on stable heart failure medicines.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Heart failure with LVEF ≤ 40%, NYHA class II, III or ambulatory IV.
- Earlier treatment
- Must be on optimal, maximally tolerated, stable guideline-directed medical therapy (GDMT).
Main reasons for not taking part
- Advanced heart failure
- Life expectancy under 12 months
- Signs of right heart dysfunction
Read by machine on 9 November 2026.
Where in New Zealand
- Christchurch HospitalChristchurch, New ZealandTaking people
- Dunedin HospitalDunedin, New ZealandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alleviant Medical, Inc.
- Trial code
- NCT06812533
- Record updated
- 6 October 2026
- Original description
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.Read full original descriptionShow less
Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction
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.
Inclusion: LVEF ≤ 40%; NYHA class II, III or ambulatory IV HF; Receiving optimal, maximally tolerated, stable GDMT.
Exclusion: Advanced heart failure; Evidence of right heart dysfunction; Life-expectancy < 12 months.