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.
Кой може да участва
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
Интервенции
Alleviant ALV1 System
DEVICE
Sham-Control
OTHER
Места на провеждане
58
Австралия (2)
Monash Health Victorian Heart Hospital
Clayton , Victoria
Alfred Hospital
Melbourne , Victoria
Белгия (3)
OLV Hospital
Aalst
ZAS Middelheim
Antwerp
AZ Sint Jan Brugge
Bruges
Канада (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
Гърция (2)
Hygeia Hospital
Athens
European Interbalken Medical Center
Thessaloniki
Израел (2)
Tel Aviv Sourasky Medical Center
Tel Aviv
Shamir Medical Center
Zrifin
New Zealand (2)
ChristChurch Hospital
Christchurch
Dunedin Hospital
Dunedin
Полша (3)
University Clinical Hospital in Opole
Opole
Narodowy Instytut Kardiologii im. Stefana kardynała Wyszyńsk
БГ
EN