Alleviant ALLAY-HF 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 40 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, Austria, Belgium, Bulgaria +10
- 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 System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure
Overview
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.
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
- Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
- NYHA Class II, III or ambulatory IV
- Exercise right heart catheterization\*
- Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
- Exercise PVR < 1.8 WU
- Ongoing stable GDMT
Exclusion criteria
- Advanced heart failure
- Presence of a pacemaker
- 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 · 53 centers
- University of Alabama — Birmingham
- Arizona Cardiovascular Research Center — Phoenix
- Pima Heart and Vascular — Tucson
- Memorial Care Long Beach Medical Center — Long Beach
- UC Davis Medical Center — Sacramento
- Scripps Clinical Research Services — San Diego
- San Francisco VA — San Francisco
- University of California San Francisco — San Francisco
- … and 45 more centers
Germany · 9 centers
- Heart and Vascular Center-Bad Bevensen — Bad Bevensen
- Herz- und Gefasszentrum Bad Bevensen — Bad Bevensen
- University of Gießen — Giessen
- Marienkrankenhaus — Hamburg
- Askelepios Klinik Altona — Hamburg
- St. Vincentius Kliniken — Karlsruhe
- Universitatsklinikum Schleswig-Holstein (UKSH) — Lübeck
- Universitätsklinikum Kardiologie — Magdeburg
- … and 1 more center
Spain · 7 centers
Center list to be confirmed — check the primary protocol.
Poland · 6 centers
Center list to be confirmed — check the primary protocol.
Belgium · 3 centers
- OLV Hospital — Aalst
- ZAS Middelheim — Antwerp
- AZ Sint Jan Brugge — Bruges
Bulgaria · 3 centers
- University Hospital UMHAT Sveti Georgi — Plovdiv
- Acibadem City Clinic University Tokuda Hospital — Sofia
- Acibadem City Clinic Cardiovascular Center Sofia — Sofia
Canada · 3 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
Israel · 3 centers
- Shaare Zedek Medical Center — Jerusalem
- Tel Aviv Sourasky Medical Center — Tel Aviv
- Shamir Medical Center — Zrifin
Australia · 2 centers
- Monash Health Victorian Heart Hospital — Clayton
- Austin Hospital — Heidelberg
Italy · 2 centers
Center list to be confirmed — check the primary protocol.
New Zealand · 2 centers
Center list to be confirmed — check the primary protocol.
Austria · 1 center
- Medizinische Universität Graz — Graz
Czechia · 1 center
- Kardiocentrum Nemocnice AGEL Trinec-Podlesi — Třinec
Georgia · 1 center
- Tbilisi Heart and Vascular — Tbilisi
Greece · 1 center
- European Interbalken Medical Center — Thessaloniki
Identifiers
NCT: NCT05685303 · CIP-0003