Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05685303
Ethics application status
Date submitted
14/12/2022
Date registered
17/01/2023
Date last updated
21/08/2024

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
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Oregon
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
South Dakota
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
United States of America
State/province [25] 0 0
Wisconsin
Country [26] 0 0
Austria
State/province [26] 0 0
Graz
Country [27] 0 0
Belgium
State/province [27] 0 0
Aalst
Country [28] 0 0
Belgium
State/province [28] 0 0
Bruges
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Georgia
State/province [31] 0 0
Tbilisi
Country [32] 0 0
Germany
State/province [32] 0 0
Bad Bevensen
Country [33] 0 0
Germany
State/province [33] 0 0
Dortmund
Country [34] 0 0
Germany
State/province [34] 0 0
Gießen
Country [35] 0 0
Germany
State/province [35] 0 0
Hamburg
Country [36] 0 0
Germany
State/province [36] 0 0
Karlsruhe
Country [37] 0 0
Germany
State/province [37] 0 0
Luebeck
Country [38] 0 0
Germany
State/province [38] 0 0
Magdeburg
Country [39] 0 0
Germany
State/province [39] 0 0
Rostock
Country [40] 0 0
Greece
State/province [40] 0 0
Thessaloníki
Country [41] 0 0
Israel
State/province [41] 0 0
Jerusalem
Country [42] 0 0
Israel
State/province [42] 0 0
Tel Aviv
Country [43] 0 0
Israel
State/province [43] 0 0
Zrifin
Country [44] 0 0
Italy
State/province [44] 0 0
Milan
Country [45] 0 0
New Zealand
State/province [45] 0 0
Christchurch
Country [46] 0 0
New Zealand
State/province [46] 0 0
Dunedin
Country [47] 0 0
Poland
State/province [47] 0 0
Poznan
Country [48] 0 0
Poland
State/province [48] 0 0
Wroclaw
Country [49] 0 0
Poland
State/province [49] 0 0
Zabrze
Country [50] 0 0
Spain
State/province [50] 0 0
Barcelona
Country [51] 0 0
Spain
State/province [51] 0 0
Cadiz
Country [52] 0 0
Spain
State/province [52] 0 0
Madrid
Country [53] 0 0
Spain
State/province [53] 0 0
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/study/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/study/NCT05685303