NCT05685303Recruiting
Alleviant ALLAY-HF Study
Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 700 (estimated)
- First submitted
- 14 Dec 2022
- Start date
- 10 Jan 2023
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Alleviant Medical, Inc.
- Diseases
- Heart failure
- NCT number
- NCT05685303
What you commit to
- Study type: Interventional
- Planned participants: 700
- From 10 Jan 2023 to the primary completion date, 1 Dec 2027
- 93 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Advanced heart failure
- Evidence of right heart dysfunction
Other
- Presence of a pacemaker
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (93)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universität Graz Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
| Monash Health Victorian Heart Hospital Coordinator of this site? Confirm its status | Clayton | Australia | Recruiting |
| Austin Hospital Coordinator of this site? Confirm its status | Heidelberg | Australia | Recruiting |
| OLV Hospital Coordinator of this site? Confirm its status | Aalst | Belgium | Recruiting |
| ZAS Middelheim Coordinator of this site? Confirm its status | Antwerp | Belgium | Recruiting |
| Az Sint Jan Brugge Coordinator of this site? Confirm its status | Bruges | Belgium | Recruiting |
| University Hospital UMHAT Sveti Georgi Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| Centre Integre Universitaire de Sainte et de Services Scoiiaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS) Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Centre Hospitalier de l'Universite de Montreal (CHUM) Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Southlake Regional Hospital Centre Coordinator of this site? Confirm its status | Newmarket | Canada | Recruiting |
| Kardiocentrum Nemocnice AGEL Trinec-Podlesi Coordinator of this site? Confirm its status | Třinec | Czechia | Recruiting |
| Marienkrankenhaus Coordinator of this site? Confirm its status | Hamburg | Germany | Terminated |
| Universitätsklinikum Schleswig-Holstein (UKSH) Coordinator of this site? Confirm its status | Lübeck | Germany | Recruiting |
| Universitätsklinikum Kardiologie Coordinator of this site? Confirm its status | Magdeburg | Germany | Recruiting |
| Germans Trias i Pujol University Hospital Coordinator of this site? Confirm its status | Barcelona | Spain | Terminated |
| Vall d'Hebron University Hospital Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Barcelona Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Puerta del Cadíz Coordinator of this site? Confirm its status | Cadiz | Spain | Terminated |
| Hospital Universitario Puerta de Hierro Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Clinico Universitario de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Valencia Hospital Clinico Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Tbilisi Heart and Vascular Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Terminated |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Shamir Medical Center Coordinator of this site? Confirm its status | Zrifin | Israel | Recruiting |
| Instituto Auxologico Italiano Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Humanitas Research Milan Coordinator of this site? Confirm its status | Rozzano | Italy | Terminated |
| Christchurch Hospital Coordinator of this site? Confirm its status | Christchurch | New Zealand | Recruiting |
| Dunedin Hospital Coordinator of this site? Confirm its status | Dunedin | New Zealand | Recruiting |
| University Clinical Hospital in Opole Coordinator of this site? Confirm its status | Opole | Poland | Recruiting |
| Poznan University of Medical Sciences Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Kashubian Center for Heart and Vascular Diseases, Pomeranian Coordinator of this site? Confirm its status | Wejherowo | Poland | Recruiting |
| 4th Military Hospital Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Uniwesytecki Szpital Kliniczny Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Silesian Center for Heart Disease Coordinator of this site? Confirm its status | Zabrze | Poland | Recruiting |
| Hendrick Health Coordinator of this site? Confirm its status | Abilene | United States | Recruiting |
| VA Ann Arbor Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Mission Hospital Coordinator of this site? Confirm its status | Asheville | United States | Recruiting |
| Austin Heart Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Johns Hopkins Medical Institution Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Boston Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Steward St. Elizabeth's Medical Center Coordinator of this site? Confirm its status | Brighton | United States | Terminated |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Advocate Illinois Masonic Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Terminated |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Prisma Health - Midlands Coordinator of this site? Confirm its status | Colombia | United States | Recruiting |
| UT Southwestern Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Atlanta VA Health Care System Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| Ascension St. John Hospital Coordinator of this site? Confirm its status | Detroit | United States | Terminated |
| Duke University Hospital Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| St. Elizabeth Healthcare Coordinator of this site? Confirm its status | Edgewood | United States | Recruiting |
| The Cardiac and Vascular Institute (TCAVI) Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| Stern Cardiovascular Foundation Coordinator of this site? Confirm its status | Germantown | United States | Recruiting |
| Pinnacle Health Cardiovascular Institute Coordinator of this site? Confirm its status | Harrisburg | United States | Recruiting |
| Hartford Hospital Coordinator of this site? Confirm its status | Hartford | United States | Terminated |
| Cardiovascular Institute of the South Coordinator of this site? Confirm its status | Houma | United States | Recruiting |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| HCA Florida Memorial Hospital Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Tennova Healthcare-Turkey Creek Medical Center Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
| UMC of Southern Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Memorial Care Long Beach Medical Center Coordinator of this site? Confirm its status | Long Beach | United States | Recruiting |
| Advocate Aurora Health/Aurora Research Institute Coordinator of this site? Confirm its status | Milwaukee | United States | Active, not recruiting |
| Minneapolis Heart Institute Foundation Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Midwest Cardiovascular Institute Coordinator of this site? Confirm its status | Naperville | United States | Recruiting |
| NCH Research Institute Coordinator of this site? Confirm its status | Naples | United States | Recruiting |
| University Medical Center New Orleans Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| VA NY Harbor Healthcare System Coordinator of this site? Confirm its status | New York | United States | Terminated |
| New York University Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Lenox Hill Hospital Coordinator of this site? Confirm its status | New York | United States | Active, not recruiting |
| South Oklahoma Heart Research LLC Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Advent Health Orlando Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Ascension Sacred Heart Coordinator of this site? Confirm its status | Pensacola | United States | Recruiting |
| Arizona Cardiovascular Research Center Coordinator of this site? Confirm its status | Phoenix | United States | Active, not recruiting |
| Baylor Scott & White Research Institute Coordinator of this site? Confirm its status | Plano | United States | Recruiting |
| Providence St. Vincent's Medical Center Coordinator of this site? Confirm its status | Portland | United States | Terminated |
| NC Heart and Vascular Research Coordinator of this site? Confirm its status | Raleigh | United States | Recruiting |
| Monument Health Coordinator of this site? Confirm its status | Rapid City | United States | Recruiting |
| St. Francis Hospital Coordinator of this site? Confirm its status | Roslyn | United States | Terminated |
| UC Davis Medical Center Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| Scripps Clinical Research Services Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Santa Barbara Cottage Hospital Coordinator of this site? Confirm its status | Santa Barbara | United States | Recruiting |
| HonorHealth Coordinator of this site? Confirm its status | Scottsdale | United States | Terminated |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Active, not recruiting |
| Prairie Education And Research Cooperative Coordinator of this site? Confirm its status | Springfield | United States | Active, not recruiting |
| Washington University St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Stony Brook Medicine Coordinator of this site? Confirm its status | Stony Brook | United States | Recruiting |
| ProMedica Toledo Hospital Coordinator of this site? Confirm its status | Toledo | United States | Recruiting |
| PIMA Heart and Vascular Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
| Waco Cardiology Coordinator of this site? Confirm its status | Waco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.