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Taking people in SpainNo phase

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
A Coruña, Barcelona, Madrid, Salamanca, and Valencia, SpainSee the 8 sites

Where in Spain

  • Hospital Universitario A CoruñaA Coruña, SpainTaking people
  • Hospital Clinic de BarcelonaBarcelona, SpainTaking people
  • Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
  • Vall d'Hebron University Hospital BarcelonaBarcelona, SpainTaking people
  • Hospital Universitario Puerta de HierroMadrid, SpainTaking people
  • Hospital Universitario 12 de OctubreMadrid, SpainNo longer taking part
  • Hospital Clinico Universitario de SalamancaSalamanca, SpainTaking people
  • Valencia Hospital ClinicoValencia, SpainTaking people

Questions to ask the study team

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  2. Are travel costs paid?
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  4. What happens if I want to stop?
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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.

ClinicalTrials.gov NCT06812533