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Alleviant ALLAY-HF Study

Primary Purpose

Heart Failure

Status
Enrolling by invitation
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Alleviant ALV1 System
Sham-Control
Sponsored by
Alleviant Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: Advanced heart failure Presence of a pacemaker Evidence of right heart dysfunction

Sites / Locations

  • University of Alabama
  • Arizona Cardiovascular Research Center
  • Honor Health
  • Pima Heart and Vascular
  • Scripps Clinical Research Services
  • San Francisco VA
  • University of California San Francisco
  • Santa Barbara Cottage Hospital
  • The Cardiac and Vascular Institute (TCAVI)
  • University of Florida Jacksonville
  • HCA Florida Memorial Hospital
  • NCH Research Institute
  • Advent Health Orlando
  • Ascension Sacred Heart
  • Atlanta VA Health Care System
  • Midwest Cardiovascular Institute
  • Prairie Education and Research Cooperative
  • St. Elizabeth Healthcare
  • Cardiovascular Institute of the South
  • University Medical Center New Orleans
  • Boston Medical Center
  • Steward St. Elizabeth's Medical Center
  • VA Ann Arbor
  • Ascension St. John Hospital
  • Minneapolis Heart Institute Foundation
  • The Valley Hospital
  • VA NY Harbor Healthcare System
  • New York University
  • Lenox Hill Hospital
  • St. Francis Hospital
  • Mission Hospital
  • Duke University Hospital
  • The MetroHealth System
  • Cleveland Clinic
  • Mount Carmel Health System
  • ProMedica Toledo Hospital
  • South Oklahoma Heart Research, LLC.
  • Providence St. Vincent's Medical Center
  • Pinnacle Health Cardiovascular Institute
  • Prisma Health - Midlands
  • Monument Health
  • Stern Cardiovascular Foundation
  • Hendrick Health
  • Austin Heart
  • UT Southwestern
  • Texas Tech University Health Sciences Center
  • Baylor Scott & White Research Institute
  • NextStage Clinical Research
  • Medizinische Universität Graz
  • OLV Hospital
  • AZ Sint Jan Brugge
  • Centre hospitalier de l'Universite de Montreal (CHUM)
  • Centre Integre Universitaire de Sainte et de Services Scoiiaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)
  • Tbilisi Heart and Vascular
  • Heart and Vascular Center-Bad Bevensen
  • St. Johannes Hospital
  • University of Gießen
  • Marienkrankenhaus
  • Askelepios Klinik Altona
  • St. Vincentius Kliniken
  • Universitatsklinikum Schleswig-Holstein (UKSH)
  • Universitätsklinikum Kardiologie
  • Universitatsmedizin Rostock
  • European Interbalken Medical Center
  • Shaare Zedek Medical Center
  • Tel Aviv Sourasky Medical Center
  • Shamir Medical Center
  • Instituto Auxologico Italiano
  • Poznan University of Medical Sciences
  • 4th Military Hospital
  • Uniwesytecki Szpital Kliniczny
  • Silesian Center for Heart Disease
  • Hospital de la Santa Creu i Sant Pau
  • Barcelona Hospital del Mar
  • Hospital Clinic de Barcelona
  • Germans Trias i Pujol
  • Cadiz Hospital Universitario Puerta del Mar
  • Hospital Universitario Puerta de Hierro
  • Valencia Hospital Clinico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment

Control

Arm Description

Subjects randomized to the treatment arm will undergo cardiac imaging, femoral vein access and receive the Alleviant ALV1 System device procedure.

Subjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 14, 2022
Last Updated
September 29, 2023
Sponsor
Alleviant Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05685303
Brief Title
Alleviant ALLAY-HF Study
Official Title
Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
April 1, 2026 (Anticipated)
Study Completion Date
July 31, 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alleviant Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Subjects randomized to the treatment arm will undergo cardiac imaging, femoral vein access and receive the Alleviant ALV1 System device procedure.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Subjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein.
Intervention Type
Device
Intervention Name(s)
Alleviant ALV1 System
Intervention Description
Creation of interatrial shunt
Intervention Type
Other
Intervention Name(s)
Sham-Control
Intervention Description
Cardiac imaging
Primary Outcome Measure Information:
Title
Composite Primary Endpoint
Description
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.
Time Frame
12-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Advanced heart failure Presence of a pacemaker Evidence of right heart dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Udelson, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Arizona Cardiovascular Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Honor Health
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Pima Heart and Vascular
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Facility Name
Scripps Clinical Research Services
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
San Francisco VA
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Santa Barbara Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
The Cardiac and Vascular Institute (TCAVI)
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
University of Florida Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States
Facility Name
HCA Florida Memorial Hospital
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
NCH Research Institute
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Advent Health Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Ascension Sacred Heart
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Atlanta VA Health Care System
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30032
Country
United States
Facility Name
Midwest Cardiovascular Institute
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
Prairie Education and Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62769
Country
United States
Facility Name
St. Elizabeth Healthcare
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
University Medical Center New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Steward St. Elizabeth's Medical Center
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
VA Ann Arbor
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Ascension St. John Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
VA NY Harbor Healthcare System
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
Mission Hospital
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
The MetroHealth System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Mount Carmel Health System
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
ProMedica Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
South Oklahoma Heart Research, LLC.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73135
Country
United States
Facility Name
Providence St. Vincent's Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Pinnacle Health Cardiovascular Institute
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Facility Name
Prisma Health - Midlands
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Monument Health
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Stern Cardiovascular Foundation
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Hendrick Health
City
Abilene
State/Province
Texas
ZIP/Postal Code
79601
Country
United States
Facility Name
Austin Heart
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
UT Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75930
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Facility Name
Baylor Scott & White Research Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
NextStage Clinical Research
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Medizinische Universität Graz
City
Graz
Country
Austria
Facility Name
OLV Hospital
City
Aalst
Country
Belgium
Facility Name
AZ Sint Jan Brugge
City
Bruges
Country
Belgium
Facility Name
Centre hospitalier de l'Universite de Montreal (CHUM)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0C1
Country
Canada
Facility Name
Centre Integre Universitaire de Sainte et de Services Scoiiaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0C1
Country
Canada
Facility Name
Tbilisi Heart and Vascular
City
Tbilisi
Country
Georgia
Facility Name
Heart and Vascular Center-Bad Bevensen
City
Bad Bevensen
ZIP/Postal Code
29549
Country
Germany
Facility Name
St. Johannes Hospital
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
University of Gießen
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Marienkrankenhaus
City
Hamburg
ZIP/Postal Code
22087
Country
Germany
Facility Name
Askelepios Klinik Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
St. Vincentius Kliniken
City
Karlsruhe
ZIP/Postal Code
76137
Country
Germany
Facility Name
Universitatsklinikum Schleswig-Holstein (UKSH)
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Universitätsklinikum Kardiologie
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Universitatsmedizin Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
European Interbalken Medical Center
City
Thessaloníki
Country
Greece
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Shamir Medical Center
City
Zrifin
Country
Israel
Facility Name
Instituto Auxologico Italiano
City
Milan
ZIP/Postal Code
20149
Country
Italy
Facility Name
Poznan University of Medical Sciences
City
Poznań
Country
Poland
Facility Name
4th Military Hospital
City
Wrocław
Country
Poland
Facility Name
Uniwesytecki Szpital Kliniczny
City
Wrocław
Country
Poland
Facility Name
Silesian Center for Heart Disease
City
Zabrze
Country
Poland
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Barcelona Hospital del Mar
City
Barcelona
ZIP/Postal Code
08033
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Cadiz Hospital Universitario Puerta del Mar
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Valencia Hospital Clinico
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Alleviant ALLAY-HF Study

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