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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05685303




Registration number
NCT05685303
Ethics application status
Date submitted
14/12/2022
Date registered
17/01/2023
Date last updated
10/06/2024

Titles & IDs
Public title
Alleviant ALLAY-HF Study
Scientific title
Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure
Secondary ID [1] 0 0
CIP-0003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Alleviant ALV1 System
Other interventions - Sham-Control

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

Sham Comparator: Control - Subjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein.


Treatment: Devices: Alleviant ALV1 System
Creation of interatrial shunt

Other interventions: Sham-Control
Cardiac imaging
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite Primary Endpoint
Timepoint [1] 0 0
12-month

Eligibility
Key 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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Advanced heart failure

2. Presence of a pacemaker

3. Evidence of right heart dysfunction

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2032
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Health Victorian Heart Hospital - Clayton
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
3068 - Clayton
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Kentucky
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United States of America
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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South Dakota
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Tennessee
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Texas
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Washington
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Wisconsin
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Austria
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Graz
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Belgium
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Aalst
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Belgium
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Bruges
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Canada
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Ontario
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Canada
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Quebec
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Georgia
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Tbilisi
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Germany
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Bad Bevensen
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Germany
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Dortmund
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Germany
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Gießen
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Germany
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Hamburg
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Germany
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Karlsruhe
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Germany
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Luebeck
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Germany
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Magdeburg
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Germany
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Rostock
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Greece
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Thessaloníki
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Israel
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Jerusalem
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Israel
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Tel Aviv
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Israel
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Zrifin
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Italy
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Milan
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New Zealand
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Christchurch
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New Zealand
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Dunedin
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Poland
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Poznan
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Poland
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Wroclaw
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Poland
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Zabrze
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Spain
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Barcelona
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Spain
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Cadiz
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Spain
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Madrid
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Spain
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Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alleviant Medical, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05685303
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James Udelson, MD
Address 0 0
Tufts Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05685303