Alleviant ALLAY-HFrEF Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Alleviant ALV1 System, Sham-Control.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Belgium, Canada, Georgia +5
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction
Overview
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.
Interventions
- Device Alleviant ALV1 System
Creation of interatrial shunt - Other Sham-Control
Cardiac imaging
Primary outcome measures
- Composite Primary Endpoint [Time frame: 12-Month]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 35 centers
- Keck Medical Center of USC — Los Angeles
- UC Davis Medical Center — Sacramento
- Scripps Clinical Research Services — San Diego
- University of California San Francisco — San Francisco
- Delray Medical Center — Delray Beach
- Ascension Sacred Heart — Pensacola
- Tampa General Hospital — Tampa
- Atlanta VA Health Care System — Decatur
- … and 27 more centers
Spain · 7 centers
- Hospital Universitario A Coruna — A Coruña
- Hospital de la Santa Creu i Sant Pau — Barcelona
- Vall d'Hebron University Hospital Barcelona — Barcelona
- Hospital Universitario 12 de Octubre — Madrid
- Hospital Universitario Puerta de Hierro — Madrid
- Hospital Clínico Universitario de Salamanca — Salamanca
- Valencia Hospital Clinico — Valencia
Canada · 4 centers
- Southlake Regional Hospital Centre — Newmarket
- Centre hospitalier de l'Universite de Montreal (CHUM) — Montreal
- Centre Integre Universitaire de Sainte et de Services Scoiiaux de l'Estrie - Centre Hospit — Montreal
- IUCPQ - Université Laval (Quebec) — Québec
Belgium · 3 centers
- OLV Hospital — Aalst
- ZAS Middelheim — Antwerp
- AZ Sint Jan Brugge — Bruges
Poland · 3 centers
- University Clinical Hospital in Opole — Opole
- Narodowy Instytut Kardiologii im. Stefana kardynała Wyszyńsk — Warsaw
- Uniwesytecki Szpital Kliniczny — Wroclaw
Australia · 2 centers
- Monash Health Victorian Heart Hospital — Clayton
- Alfred Hospital — Melbourne
Greece · 2 centers
- Hygeia Hospital — Athens
- European Interbalken Medical Center — Thessaloniki
Israel · 2 centers
- Tel Aviv Sourasky Medical Center — Tel Aviv
- Shamir Medical Center — Zrifin
New Zealand · 2 centers
- ChristChurch Hospital — Christchurch
- Dunedin Hospital — Dunedin
Georgia · 1 center
- Tbilisi Heart and Vascular — Tbilisi
Identifiers
NCT: NCT06812533 · CIP-0006