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.
Who can participate
Inclusion Criteria:
1. Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
2. NYHA Class II, III or ambulatory IV
3. Exercise right heart catheterization\*
1. Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
2. Exercise PVR \< 1.8 WU
4. Ongoing stable GDMT
Exclusion Criteria:
1. Advanced heart failure
2. Presence of a pacemaker
3. Evidence of right heart dysfunction
Interventions
Alleviant ALV1 System
DEVICE
Sham-Control
OTHER
Locations
97
Australia (2)
Monash Health Victorian Heart Hospital
Clayton , Victoria
Austin Hospital
Heidelberg , Victoria
Austria (1)
Medizinische Universität Graz
Graz
Belgium (3)
OLV Hospital
Aalst
ZAS Middelheim
Antwerp
AZ Sint Jan Brugge
Bruges
Bulgaria (3)
University Hospital UMHAT Sveti Georgi
Plovdiv
Acibadem City Clinic University Tokuda Hospital
Sofia
Acibadem City Clinic Cardiovascular Center Sofia
Sofia
Canada (3)
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
Czech Republic (1)
Kardiocentrum Nemocnice AGEL Trinec-Podlesi
Třinec
Georgia (1)
Tbilisi Heart and Vascular
Tbilisi
Germany (9)
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
Universitatsmedizin Rostock
Rostock
Greece (1)
European Interbalken Medical Center
Thessaloniki
Israel (3)
Shaare Zedek Medical Center
Jerusalem
Tel Aviv Sourasky Medical Center
Tel Aviv
Shamir Medical Center
Zrifin
Italy (2)
Instituto Auxologico Italiano
Milan
Humanitas Research Milan
Rozzano , MI
New Zealand (2)
ChristChurch Hospital
Christchurch
Dunedin Hospital
Dunedin
Poland (6)
University Clinical Hospital in Opole
Opole
Poznan University of Medical Sciences
Poznan
Kashubian Center for Heart and Vascular Diseases, Pomeranian
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