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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/NCT04838353




Registration number
NCT04838353
Ethics application status
Date submitted
1/04/2021
Date registered
9/04/2021
Date last updated
27/07/2022

Titles & IDs
Public title
Alleviate-HF-2 Study
Scientific title
Evaluation of the Safety and Effectiveness of a Percutaneously Created Interatrial Shunt to Alleviate Heart Failure Symptoms in Patients With Chronic Heart Failure and Preserved or Mid-Range Left Ventricular Ejection Fraction
Secondary ID [1] 0 0
CIP-0002
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 - ALV1 System

Treatment: Devices: ALV1 System
The ALV1 system is designed to create a controlled size interatrial shunt via a proprietary intra-cardiac catheter. There is no temporary or permanent implant used to create or maintain the interatrial shunt. The therapy is intended to be delivered in a single procedure administered under general anesthesia in a cardiac catheterization laboratory.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The composite incidence of one or more major adverse cardiac, cerebrovascular and thromboembolic events and change in supine exercise PCWP at peak exercise.
Timepoint [1] 0 0
At 1 month and through 12 months

Eligibility
Key inclusion criteria
1. NYHA Class II at screening with a prior history of greater than NYHA Class II, OR NYHA
Class III at screening, OR ambulatory Class IV at screening: with documented medical
history of heart failure for at least 6 months prior to the screening visit.

2. Medical history within the past 12 months of at least one hospitalization with heart
failure as the primary or secondary diagnosis OR treatment with IV diuretics for heart
failure..

3. LVEF (by Echo) > 40% as measured by the study-specific transthoracic echocardiography.

4. Echocardiographic evidence of diastolic dysfunction documented by one or more of the
following as measured by the study-specific transthoracic echocardiography protocol:

1. LA diameter > 4cm

2. LA volume index >28 mL

3. Lateral e' <10 cm/s

4. Septal e' <8 cm/s

5. Lateral E/e' >10

6. Septal E/e' >15

5. As measured by the study-specific exercise hemodynamic right heart catheterization
protocol performed during screening: Elevated left atrial pressure WITH a gradient
compared to right atrial pressure (RAP) documented by: (1) end-expiratory PCWP at peak
supine cycle ergometer exercise = 25mmHg AND (2) PCWP greater than RAP by = 5 mmHg, OR
(1) = 10 mmHg increase of end-expiratory PCWP at peak supine cycle ergometer exercise
compared to resting PCWP AND (2) PCWP greater than RAP by = 5 mmHg. Patients must also
have PCWP greater than RAP by = 5 mmHg at rest.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presence of advanced heart failure defined as one or more of the following:

- ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF.

- Cardiac index less than 2.0 L/min/m2.

- Patient is on the cardiac transplant waiting list.

- Inotropic infusion (continuous or intermittent) for EF less than 40% within the
past 6 months.

2. Presence of moderate or worse valve disease, defined as one or more of the following:

- Moderate or worse mitral valve regurgitation or moderate or worse mitral
stenosis.

- Moderate or worse tricuspid valve regurgitation.

- Moderate or worse aortic valve disease defined as moderate or worse AS or AI.

3. . Presence of chronic pulmonary disease defined by one or more of the following:

- Requirement for continuous home oxygen use.

- Hospitalization within the past 12 months for treatment of pulmonary disease.

- Significant chronic pulmonary disease defined as FEV1 less than 50%.

4. Documented as currently requiring dialysis or estimated GFR less than 25ml/min/1.73m2

5. 6-minute walk distance less than 50 m or greater than 450 m performed during
screening.

6. Documented atrial fibrillation with ventricular rate greater than 100 BPM at
screening.

7. Presence of moderate or worse right heart dysfunction OR RV dysfunction defined as
TAPSE less than 14 mm or RVFAC less than or equal to 30%

8. Presence of pulmonary hypertension with PASP greater than or equal to 70 mmHg OR PVR
greater than 4 Wood units.

9. Presence of anatomic anomaly that precludes creation of interatrial shunt (including
patent foramen ovale, atrial septal defect, target septal thickness greater than 3 mm)

10. SBP greater than 170 mmHg at screening.

11. Documented left ventricular end diastolic diameter greater than 6 cm.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Montréal
Country [2] 0 0
New Zealand
State/province [2] 0 0
Dunedin
Country [3] 0 0
Sweden
State/province [3] 0 0
Stockholm

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

Ethics approval
Ethics application status

Summary
Brief summary
Patients with heart failure and preserved left ventricular ejection fraction (HFpEF, EF =
50%) or mid-range left ventricular ejection fraction (HFmrEF, 40% < EF < 50%) with mild to
moderate functional limitation will be evaluated for treatment via creation of a no-implant
interatrial shunt using clinical, echocardiographic, and invasive hemodynamic data
Trial website
https://clinicaltrials.gov/ct2/show/NCT04838353
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT04838353