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Trial registered on ANZCTR


Registration number
ACTRN12619000602123
Ethics application status
Approved
Date submitted
20/02/2019
Date registered
18/04/2019
Date last updated
18/04/2019
Date data sharing statement initially provided
18/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Study to Assess the Safety, Hemodynamic and Electrophysiologic Effect of Left Atrial Decompression by an InterAtrial Shunt Device (IASD) in Patients Undergoing Pulmonary Vein Isolation.
Scientific title
A Pilot Study to Assess the Safety, Hemodynamic and Electrophysiologic Effect of Left Atrial Decompression by an InterAtrial Shunt Device (IASD) in Patients Undergoing Pulmonary Vein Isolation with atrial fibrillation
Secondary ID [1] 297475 0
NIL KNOWN
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiology 311647 0
Heart Failure 311648 0
Atrial Fibrillation 311650 0
Condition category
Condition code
Cardiovascular 310271 310271 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study device: The name of the device is the IASD System II. It is called an investigational or study device because it has not yet been proven to be safe or effective by The Therapeutic Goods Administration (TGA). The device has two main parts. The first part is a permanent implant that is placed inside the heart. The second part is a tube called a delivery catheter that puts the implant in the heart and then is removed.
The implant is made of the same metal that has been used for over 20 years in other heart devices. The implant shape is two disks with a small open tunnel in the middle. The implant can be folded into the delivery catheter so the study doctor can place it inside the heart. This is done during a procedure called a cardiac catheterisation. The implant stays in the heart for the rest of the subject's lifespan.

The intervention administered for this current study is using an IASD device to improve hemodynamic and electrophysiologic outcomes in patients undergoing repeat pulmonary vein isolation for AF treatment. This study is a pilot study to assess safety and feasibility, together with exploratory hemodynamic and electrophysiologic end-points.

All of the study candidates will be assessed by the a trained cardiologist. If the study participants proceed to the implant stage, the study device will be implanted by a highly trained intervention cardiologist in a 1-2 hour cath lab session.
Intervention code [1] 313716 0
Treatment: Devices
Comparator / control treatment
Standard of care - medication and device intervention to achieve rate and rhythm control
Device intervention may be an AF ablation or pacemakers.
Control group
Active

Outcomes
Primary outcome [1] 319166 0
This study is a pilot study to assess safety and feasibility,
These tools include:
post procedure details - source documentation.
Assessment of Atrial Fibrillation: ECG and holter
Assessment of pulmonary pressures: exercise right heart cath
Assessment of ejection fraction: MRIs and Echocardiograms
Assessment of pt condition: NYHA and physical assessment
cardiac bio markers - bloods (eg BNP, NT-pro-BNP, Troponin)
heart failure questionnaires - KCCQ +/- EQ-5D-3L

Clinical Data will be collected periodically (including pre and post procedure) and be reviewed to determine the safety and feasibility.
Timepoint [1] 319166 0
12 months post intervention (study device implanted)
Secondary outcome [1] 367160 0
Exploratory hemodynamic end-points.
Hemodynamic end points: examining the results from an exercise right heart catheter including measuring various pressures in the heart and lungs at rest and under exertion and assessing the changes pre and post device (ex RHC will be done pre-procedure and at 3 months post)

Timepoint [1] 367160 0
12 months post intervention (study device implant)
Secondary outcome [2] 368561 0
Exploring electrophysiologic endpoints.

Exploratory analyses of the change in electrophysiology: ECGs will be conducted to examine any rhythm changes in the subject and a holter monitor will be used to record the same at baseline, post device, 6 month and 12 month follow up.
Timepoint [2] 368561 0
12 months post intervention

Eligibility
Key inclusion criteria
Patients undergoing repeat pulmonary vein isolation for atrial fibrillation (as directed by the Electrophysiology Service in the Alfred Hospital, Cardiology Department)
2. Subject aged above 40 years
3. Symptoms of exertional breathlessness (NYHA III-III)
4. Echocardiographic or MRI evidence for LV ejection fraction equals 40% within the past 6 months
5. Echocardiographic or MRI evidence for left atrial enlargement (Left Atrial Volume Index >34 mL/m sq)
6. Qualifying hemodynamics (performed within 60 days prior to PVI), including:
a. End-expiratory resting PCWP equals 18 mm Hg, and greater than RAP by and electrophysiologic 5 mm Hg; OR
b. End-expiratory exercise PCWP above 25mm Hg, and greater than RAP by and electrophysiologic 5 mm Hg.
7. Anticoagulation
8. Subject provides written informed consent
The IASD will be implanted if all inclusion/exclusion criteria have been met AND the PVI procedure has been completed successfully and without complication
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Candidates for this study will be excluded if any of the following are present:
1. Cardiac surgery (including CABG, valve replacement) in the past 12 months
2. Acute coronary syndrome or MI in the past 3 months
3. NYHA Class IV heart failure symptoms
4. Significant valvular heart disease:
a. Mitral valve disease defined as grade equals 3+ MR or above mild MS
b. Tricuspid valve regurgitation defined as grade equals 2+ TR;
c. Aortic valve disease defined as equals 2+ AR or above moderate AS
5. Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or other infiltrative cardiomyopathy (e.g. hemochromatosis, sarcoidosis)
6. Evidence of right ventricular dysfunction including one or more of: >mild RV dysfunction (visually), RV FAC<35% or TAPSE <1.4cm
7. Any life limiting condition with a life expectancy of <2 years
8. Evidence of significant renal or hepatic dysfunction defined as eGFR<30 umol/L or hepatic transaminase 3x ULN.
9. Resting right atrial pressure > 14 mmHg
10. Evidence of significant pulmonary hypertension defined as PVR > 3.5 Wood units
11. Chronic pulmonary disease requiring continuous home oxygen, OR significant chronic pulmonary disease defined as FEV1 above 1L.
12. Hemoglobin above 10 g/dl
13. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
14. Known or suspected allergy to nickel
15. Fertile women
16. Systolic blood pressure above 170 mm Hg.
17. Subjects on significant immunosuppressive treatment or on systemic steroid treatment (above 10 mg prednisone per day).

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)
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
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The current study is a pilot safety and feasibility study. Up to 20 patients will be recruited with an interim analyses at n=10. Exploratory analyses of the change in hemodynamic and electrophysiology (ECG, Holter) will be conducted at the interim and final analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2019
Actual
Date of last participant enrolment
Anticipated
30/12/2020
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 302032 0
Commercial sector/Industry
Name [1] 302032 0
Corvia medical
Country [1] 302032 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Corvia Medical
Address
Suite 300, Corvia Medical INC 1 Highwood Drive Tewksbury MA 01876 USA.
Country
United States of America
Secondary sponsor category [1] 301831 0
None
Name [1] 301831 0
NA
Address [1] 301831 0
NA
Country [1] 301831 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302713 0
Alfred Hospital Ethics Commitee
Ethics committee address [1] 302713 0
Ethics committee country [1] 302713 0
Australia
Date submitted for ethics approval [1] 302713 0
04/12/2018
Approval date [1] 302713 0
11/02/2019
Ethics approval number [1] 302713 0
615/18

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

Contacts
Principal investigator
Name 40778 0
Prof David Kaye
Address 40778 0
Alfred Hospital
Commercial Road, Victoria
Melbourne 3004
Country 40778 0
Australia
Phone 40778 0
+61 3 90762948
Fax 40778 0
+61 3 90762948
Email 40778 0
[email protected]
Contact person for public queries
Name 40779 0
Vivian Mak
Address 40779 0
Alfred Hospital
Commercial Road, Victoria
Melbourne 3004
Country 40779 0
Australia
Phone 40779 0
+61 03 90762948
Fax 40779 0
+61 03 90762948
Email 40779 0
[email protected]
Contact person for scientific queries
Name 40780 0
Vivian Mak
Address 40780 0
Alfred Hospital
Commercial Road, Victoria
Melbourne 3004
Country 40780 0
Australia
Phone 40780 0
+61 03 90762948
Fax 40780 0
+61 03 90762948
Email 40780 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Undecided at this point


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.