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.
Who can participate
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
Interventions
Alleviant ALV1 System
DEVICE
Sham-Control
OTHER
Locations
58
Australia (2)
Monash Health Victorian Heart Hospital
Clayton , Victoria
Alfred Hospital
Melbourne , Victoria
Belgium (3)
OLV Hospital
Aalst
ZAS Middelheim
Antwerp
AZ Sint Jan Brugge
Bruges
Canada (4)
Centre hospitalier de l'Universite de Montreal (CHUM)
Montreal , Quebec
Centre Integre Universitaire de Sainte et de Services Scoiiaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)
Montreal , Quebec
Southlake Regional Hospital Centre
Newmarket , Ontario
IUCPQ - Université Laval (Quebec)
Québec
Georgia (1)
Tbilisi Heart and Vascular
Tbilisi
Greece (2)
Hygeia Hospital
Athens
European Interbalken Medical Center
Thessaloniki
Israel (2)
Tel Aviv Sourasky Medical Center
Tel Aviv
Shamir Medical Center
Zrifin
New Zealand (2)
ChristChurch Hospital
Christchurch
Dunedin Hospital
Dunedin
Poland (3)
University Clinical Hospital in Opole
Opole
Narodowy Instytut Kardiologii im. Stefana kardynała Wyszyńsk
БГ