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Trial registered on ANZCTR


Registration number
ACTRN12620001213932p
Ethics application status
Submitted, not yet approved
Date submitted
4/09/2020
Date registered
16/11/2020
Date last updated
16/11/2020
Date data sharing statement initially provided
16/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Alleviant Medical Percutaneously Created Inter-atrial Shunt on Heart Failure Symptoms in Patients with Chronic Heart Failure and Preserved or Mid-Range Left Ventricular Ejection Fraction
Scientific title
Evaluation of the Safety and Effectiveness of a Percutaneously Created Interatrial Shunt on Heart Failure Symptoms in Patients with Chronic Heart Failure and Preserved or Mid-Range Left Ventricular Ejection Fraction
Secondary ID [1] 302012 0
None
Universal Trial Number (UTN)
Trial acronym
ALLEVIATE-HF-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 318570 0
Condition category
Condition code
Cardiovascular 316585 316585 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with Heart Failure with preserved or mid range Ejection Fraction (HFpEF) fulfilling the inclusion / exclusion criteria will be treated once with the Alleviant Medical Interatrial Shunt System. This system creates a controlled size interatrial shunt via a proprietary catheter to the atrial septum during one treatment procedure. The therapy is delivered administered under general anaesthesia in a cardiac catheterisation laboratory by an structural heart / interventional cardiologist. The procedure will take approximately one to two hours. Efficacy is measured intra-procedurally by detection of the shunt determined by trans esophageal echocardiography (TEE) or Intra-Cardiac Echo (ICE).
Intervention code [1] 318299 0
Treatment: Devices
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324716 0
The composite incidence of one or more of the following through the 1-month follow-up visit: major adverse cardiac, cerebrovascular and thromboembolic events (defined as cardiovascular death, embolic stroke, embolic myocardial infarction, pulmonary or arterial embolism, device and/or procedure-related serious adverse cardiac events). This outcome will be assessed by an evaluation of patient history and medical records.
Timepoint [1] 324716 0
At one month following the shunt procedure (interventional procedure).
Primary outcome [2] 324717 0
Change in supine exercise Pulmonary Capillary Wedge Pressure at peak exercise from baseline to 1 Month post interventional procedure. This outcome is measured by the patient undertaking the Right Heart Catheter procedure.
Timepoint [2] 324717 0
At one month following the shunt procedure (interventional procedure).
Secondary outcome [1] 386508 0
Technical success (site reported Echo confirmation of shunt creation with left-to-right flow and confirmation of excised septal tissue with no procedure-related serious adverse cardiac events).
Timepoint [1] 386508 0
At conclusion of interventional procedure
Secondary outcome [2] 387736 0
All serious adverse events through to six months of follow-up based upon patient reporting of events and review of patient medical records.
Timepoint [2] 387736 0
At six months following investigational procedure.
Secondary outcome [3] 387737 0
All-cause mortality, CV mortality, and heart failure-related mortality within 12 months of investigational procedure.
Timepoint [3] 387737 0
At 12 months following investigational procedure.
Secondary outcome [4] 387738 0
Need for shunt closure through twelve months of follow-up based upon haemodynamic measurements (transesophageal echocardiography) and patient feedback regarding heart failure symptoms.
Timepoint [4] 387738 0
At twelve months following investigational procedure.
Secondary outcome [5] 387739 0
Change in NYHA Functional Class from baseline to Month one, three, six and twelve.
Timepoint [5] 387739 0
At one, three, six and twelve months following investigational procedure.
Secondary outcome [6] 387740 0
Burden of heart failure symptoms as indicated by a change in KCCQ score from baseline to month one, three, six and twelve following investigational procedure.
Timepoint [6] 387740 0
At months one, three, six and twelve following investigational procedure.
Secondary outcome [7] 387741 0
Change in activity (via actigraphy) from baseline to month one following investigational procedure.
Timepoint [7] 387741 0
At one month following investigational procedure.
Secondary outcome [8] 387742 0
Change in shunt flow via transthoracic echo from Day zero (index procedure) to month one, three, six and twelve following investigational procedure.
Timepoint [8] 387742 0
At month one, three, six and twelve following investigational procedure.

Eligibility
Key inclusion criteria
Candidates for the study must meet all of the following inclusion criteria at
screening:
1. Documented history of NYHA Class II, Class III or ambulatory Class IV at the screening visit.
2. History of at least one hospitalization for treatment of heart failure within the past 12 months.
3. LVEF greater than or equal to 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 performed during screening:
- LA diameter greater than 4 cm
- LA volume index greater than 28 mL
- Lateral e’ less than 10 cm/s
- Septal e’ less than 8 cm/s
- Lateral E/e’ greater than 10
- Septal E/e’ greater than 15
5. 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 greater than or equa. to 25 mmHg AND
(2) PCWP greater than RAP by greater than or equal to 5 mmHg, OR greater than or equal to 10 mmHg increase of end-expiratory PCWP at peak supine cycle ergometer exercise compared to resting PCWP AND PCWP greater than RAP by greater than or equal to 5 mmHg.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Candidates for the study must be free of all of the following exclusion
criteria at screening:
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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The study is not powered to show statistical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
Date of last participant enrolment
Anticipated
31/10/2021
Actual
Date of last data collection
Anticipated
30/10/2022
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 17246 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 17247 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 30957 0
3168 - Clayton
Recruitment postcode(s) [2] 30958 0
5042 - Bedford Park
Recruitment outside Australia
Country [1] 22823 0
New Zealand
State/province [1] 22823 0
Southern District Health Board

Funding & Sponsors
Funding source category [1] 306433 0
Commercial sector/Industry
Name [1] 306433 0
Alleviant Medical Inc.
Country [1] 306433 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Alleviant Medical Inc.
Address
7801 N Lamar Blvd.
Suite D-106
Austin, Texas, 78752, USA
Country
United States of America
Secondary sponsor category [1] 306948 0
None
Name [1] 306948 0
Address [1] 306948 0
Country [1] 306948 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306641 0
Monash Health
Ethics committee address [1] 306641 0
Ethics committee country [1] 306641 0
Australia
Date submitted for ethics approval [1] 306641 0
04/09/2020
Approval date [1] 306641 0
Ethics approval number [1] 306641 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104522 0
Dr Robert Gooley
Address 104522 0
Monash Health
Monash Medical Centre
Clayton Road
Clayton VIC 3168
Country 104522 0
Australia
Phone 104522 0
+61 03 9594 4507
Fax 104522 0
Email 104522 0
Robert.Gooley@monashhealth.org
Contact person for public queries
Name 104523 0
Matthew Godden
Address 104523 0
Australian Healthcare Solutions Pty Ltd.
P.O. Box 3270
The Pines
Doncaster East, VIC 3109
Country 104523 0
Australia
Phone 104523 0
+61 400 007 127
Fax 104523 0
Email 104523 0
matt@australianhealthcaresolutions.com.au
Contact person for scientific queries
Name 104524 0
Noah Bartsch
Address 104524 0
Alleviant Medical Inc.
7801 N Lamar Blvd.
Suite D-106
Austin, Texas, 78752, USA
Country 104524 0
United States of America
Phone 104524 0
+1 517 402 8200
Fax 104524 0
Email 104524 0
noah.bartsch@alleviantmedical.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual Data Not Available


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.