Alleviant ALLAY-HF Study

Heart Failure Clinical Trial

Official title:

Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05685303
• Other study ID #: CIP-0003
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: July 31, 2032

Study information

• Verified date: June 2024
• Source: Alleviant Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: July 31, 2032
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Alleviant ALV1 System
Creation of interatrial shunt

Other:
• Sham-Control
Cardiac imaging

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
Australia	Monash Health Victorian Heart Hospital	Clayton	Victoria
Austria	Medizinische Universität Graz	Graz
Belgium	OLV Hospital	Aalst
Belgium	AZ Sint Jan Brugge	Bruges
Canada	Centre hospitalier de l'Universite de Montreal (CHUM)	Montréal	Quebec
Canada	Centre Integre Universitaire de Sainte et de Services Scoiiaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)	Montréal	Quebec
Canada	Southlake Regional Hospital Centre	Newmarket	Ontario
Georgia	Tbilisi Heart and Vascular	Tbilisi
Germany	Heart and Vascular Center-Bad Bevensen	Bad Bevensen
Germany	St. Johannes Hospital	Dortmund
Germany	University of Gießen	Gießen
Germany	Askelepios Klinik Altona	Hamburg
Germany	Marienkrankenhaus	Hamburg
Germany	St. Vincentius Kliniken	Karlsruhe
Germany	Universitatsklinikum Schleswig-Holstein (UKSH)	Luebeck
Germany	Universitätsklinikum Kardiologie	Magdeburg
Germany	Universitatsmedizin Rostock	Rostock
Greece	European Interbalken Medical Center	Thessaloníki
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	Shamir Medical Center	Zrifin
Italy	Instituto Auxologico Italiano	Milan
New Zealand	ChristChurch Hospital	Christchurch
New Zealand	Dunedin Hospital	Dunedin
Poland	Poznan University of Medical Sciences	Poznan
Poland	4th Military Hospital	Wroclaw
Poland	Uniwesytecki Szpital Kliniczny	Wroclaw
Poland	Silesian Center for Heart Disease	Zabrze
Spain	Barcelona Hospital del Mar	Barcelona
Spain	Germans Trias i Pujol	Barcelona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Cadiz Hospital Universitario Puerta del Mar	Cadiz
Spain	Hospital Universitario Puerta de Hierro	Madrid
Spain	Valencia Hospital Clinico	Valencia
United States	Hendrick Health	Abilene	Texas
United States	VA Ann Arbor	Ann Arbor	Michigan
United States	Mission Hospital	Asheville	North Carolina
United States	Austin Heart	Austin	Texas
United States	Johns Hopkins Medical Institution	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Steward St. Elizabeth's Medical Center	Brighton	Massachusetts
United States	Advocate Illinois Masonic Medical Center	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	The MetroHealth System	Cleveland	Ohio
United States	Prisma Health - Midlands	Columbia	South Carolina
United States	Mount Carmel Health System	Columbus	Ohio
United States	UT Southwestern	Dallas	Texas
United States	Atlanta VA Health Care System	Decatur	Georgia
United States	Ascension St. John Hospital	Detroit	Michigan
United States	Duke University Hospital	Durham	North Carolina
United States	St. Elizabeth Healthcare	Edgewood	Kentucky
United States	The Cardiac and Vascular Institute (TCAVI)	Gainesville	Florida
United States	Stern Cardiovascular Foundation	Germantown	Tennessee
United States	Pinnacle Health Cardiovascular Institute	Harrisburg	Pennsylvania
United States	Hartford Hospital	Hartford	Connecticut
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	HCA Florida Memorial Hospital	Jacksonville	Florida
United States	University of Florida Jacksonville	Jacksonville	Florida
United States	Tennova Healthcare - Turkey Creek Medical Center	Knoxville	Tennessee
United States	Memorial Care Long Beach Medical Center	Long Beach	California
United States	Baptist Health Louisville Cardiology Research	Louisville	Kentucky
United States	Advocate Aurora Health/Aurora Research Institute	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	Midwest Cardiovascular Institute	Naperville	Illinois
United States	NCH Research Institute	Naples	Florida
United States	University Medical Center New Orleans	New Orleans	Louisiana
United States	Lenox Hill Hospital	New York	New York
United States	New York University	New York	New York
United States	VA NY Harbor Healthcare System	New York	New York
United States	South Oklahoma Heart Research, LLC.	Oklahoma City	Oklahoma
United States	Advent Health Orlando	Orlando	Florida
United States	Ascension Sacred Heart	Pensacola	Florida
United States	Arizona Cardiovascular Research Center	Phoenix	Arizona
United States	Baylor Scott & White Research Institute	Plano	Texas
United States	Providence St. Vincent's Medical Center	Portland	Oregon
United States	Monument Health	Rapid City	South Dakota
United States	The Valley Hospital	Ridgewood	New Jersey
United States	St. Francis Hospital	Roslyn	New York
United States	Scripps Clinical Research Services	San Diego	California
United States	San Francisco VA	San Francisco	California
United States	University of California San Francisco	San Francisco	California
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	Honor Health	Scottsdale	Arizona
United States	University of Washington	Seattle	Washington
United States	Prairie Education and Research Cooperative	Springfield	Illinois
United States	Stony Brook Medicine	Stony Brook	New York
United States	ProMedica Toledo Hospital	Toledo	Ohio
United States	Pima Heart and Vascular	Tucson	Arizona
United States	NextStage Clinical Research	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alleviant Medical, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Georgia,  Germany,  Greece,  Israel,  Italy,  New Zealand,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Primary Endpoint	The primary endpoint is a composite of mortality, heart failure events and quality of life based on Kansas City Cardiomyopathy Questionnaire (KCCQ) calculated at 12 months. KCCQ responses are provided along a rating scale from 0-100 with a higher score indicating better health.	12-month