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Trial registered on ANZCTR


Registration number
ACTRN12621000203853
Ethics application status
Approved
Date submitted
12/11/2020
Date registered
26/02/2021
Date last updated
26/02/2021
Date data sharing statement initially provided
26/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot Study of an Extra Aortic Counterpulsation Device acutely attached to the ascending aorta in the open chest for patients with hypertensive heart failure
Scientific title
Pilot Study assessing blood flow changes in patients with hypertensive heart failure fitted with an Extra Aortic Counterpulsation Device (BioQ CA) acutely attached to the ascending aorta in the open chest
Secondary ID [1] 297749 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular 312085 0
Hypertensive heart failure 312086 0
Hypertension 312087 0
aortic stiffness 320148 0
Condition category
Condition code
Cardiovascular 310647 310647 0 0
Hypertension
Cardiovascular 317658 317658 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The BIOQ CA is a passive recoil extra aortic balloon that is strapped to the ascending aorta using a vessel cuff that wraps around the vessel. The device is then inflated up to the blood pressure of the patient and active for 30 minutes of testing. The BioQ CA device dampens the pressure pulse when the heart ejects blood charging the device, and discharges pushing back on the vessel when the heart is filling. This is achieved by the compression and expansion of the balloon and the air contained within it. The device is implanted by the treating cardiac surgeon prior to performing the scheduled procedure while the patient in under general anaesthesia.

Patients will be grouped into 2 groups as follows:
Group 1 will consist of up to 20 patients with hypertensive HF with low ejection fraction (30% - 45% EF).
Group 2 will consist of up to 20 patients with hypertensive HF with preserved ejection fraction (>50% EF).
Intervention code [1] 313990 0
Treatment: Devices
Comparator / control treatment
Each study participant is measured without the investigational treatment (control group) and compared to the measures with the treatment of the device (treatment group).

Control assessments without the device are taken for 30 minutes prior to the device being applied,
Control group
Active

Outcomes
Primary outcome [1] 319492 0
Measure the heart's blood flow and pressure changes with the use of the device to determine the device's ability to provide a therapeutic treatment for heart failure and drug resistant hypertension.
Measurements will be made using the operating theatre monitoring equipment including a cardiac output catheter and echocardiography.
Timepoint [1] 319492 0
Measurements will be made during a 30 minute period before applying the device and during a 30 minute period after implantation of the device.
Primary outcome [2] 325984 0
Any adverse events with the use of the device will be investigated by the surgical investigators during device use and after removal by examination of the aorta by visual examination and echocardiography.
The aorta will be later examined using echocardiography during a scheduled follow up examination.
Timepoint [2] 325984 0
Device adverse events will be monitored during the 30 minutes of use and for a minimum of 30 minutes after device removal during the scheduled procedure time. Echocardiography will be used to examine the patient's aorta during a scheduled follow up examination 8 weeks after the scheduled surgery.
Secondary outcome [1] 390060 0
Device features for successful surgical attachment and removal.
The time for attaching and adjusting and then removal as well as surgeon feedback will be used to determine the difficulty and ease of use.
Device attachment and adjustment times will be recorded in case report forms and reviewed. Surgeon feedback in the case report form section and via interview will be conducted for review.
Timepoint [1] 390060 0
After 30 minutes of control measurements (no device), the device will be attached for 30 minutes and removed.

Eligibility
Key inclusion criteria
Inclusion criteria will include
• Adults of 18 years or over
• Patient has read and signed the informed consent prior to study related procedures
• Willing and able to comply with all required follow-up evaluations and assessments
• Patients scheduled for Coronary Artery Bypass Grafting (CABG) will be assessed for:
1) hypertension and ejection fraction (EF) cut-offs defined below,
2) Presence of heart failure ( Class I to IV),
3) coronary artery disease,
4) aortic stiffness,
5) stroke risk,
6) valve dysfunction,
7) aortic calcification and atherosclerosis
8) ischemia/non-ischemia classification.

o Group 1 will consist of up to 20 patients with hypertensive heart failure PLUS low ejection fraction (30% - 45% EF).
o Group 2 will consist of up to 20 patients with hypertensive heart failure PLUS preserved ejection fraction (>50% EF).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include:
• history of previous stroke,
• significant mitral and or aortic valve disease/dysfunction,
• ascending aortic disease calcification or atherosclerosis or aneurysm.
• intraoperative echo or epi-aortic ultrasound will be used during the surgical procedures to exclude or confirm presence of severe aortic disease before applying the device as a final precautionary measure prior to placement. Patients will be excluded at this point if they are confirmed in the exclusion criteria.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/02/2021
Date of last participant enrolment
Anticipated
8/02/2022
Actual
Date of last data collection
Anticipated
8/04/2022
Actual
Sample size
Target
40
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17957 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 31830 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 302273 0
Commercial sector/Industry
Name [1] 302273 0
BIOQ DEVICES PTY LTD
Country [1] 302273 0
Australia
Funding source category [2] 302275 0
Government body
Name [2] 302275 0
Australia India Strategic Research Fund (Department of Science)
Country [2] 302275 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
BIOQ DEVICES PTY LTD
Address
Suite 3, 52 High street, Toowong, QLD 4066
Country
Australia
Secondary sponsor category [1] 302149 0
None
Name [1] 302149 0
Address [1] 302149 0
Country [1] 302149 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302950 0
Monash Health
Ethics committee address [1] 302950 0
Research Support Services
Level 2, i Block,
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [1] 302950 0
Australia
Date submitted for ethics approval [1] 302950 0
20/03/2019
Approval date [1] 302950 0
03/06/2020
Ethics approval number [1] 302950 0
RES-19-0000-218A

Summary
Brief summary
We propose treating hypertensive moderate heart failure by directly treating aortic stiffness (increasing aortic distensibility; increasing expansion and contraction). Our passive recoil extra aortic balloon counterpulsation device, the BioQ Cardiac Assist device (BioQ CA), reduces aortic stiffness leading to a reduction in afterload, achieving reduced pulse and mean aortic pressures in pilot animal testing by 27% and 10% respectively, and improved left coronary artery (LCA) blood flow by 39%. The device is minimally invasive, non-blood contacting, failure mode safe, and requires no pump, leads, or ECG timing, and is a cost effective approach. Additionally, the device offers the ability to adjust its performance post implantation (for future chronic studies) by changing balloon pressure via a subcutaneous inflation port. Device proof-of-principle has been established where the BioQ CA device has shown to operate as a counterpulsation device by decreasing heart load, reducing pulse and mean pressures, and improving left coronary artery blood flow. These changes are within the range of improvement achieved with pump powered Intra-Aortic Balloon Pump (IABP) and extra-aortic balloon (EAB) systems, and the blood pressure reduction achieved with renal denervation and barostim modulation, demonstrating our passive recoil counterpulsation device is competitive on performance yet with the advantages of being a simple self-powered, stand alone device, offering superior cost savings compared to other technology approaches. More recently the device was implanted in two patients in India prior to scheduled coronary artery bypass grafting (CABG). Devices were attached around the ascending aorta for approx. 30 minutes with increases in left coronary artery (LCA) blood flow of 30% to 100% measured, cardiac output improvements of up to 18%, and heart rate decreased by 8%. Patients recovered normally and were released from hospital with no adverse events. This data is very competitive and justifies further acute studies before considering a chronic human study.
In this pilot study, we propose to test up to 40 patients with the device for 30 minutes on consenting patients who are scheduled for CABG. Testing will be done during vessel harvesting to minimise procedure time. We aim to measure LCA blood flow, arterial blood pressures, and cardiac output.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91950 0
Prof Julian Smith
Address 91950 0
Monash Medical Centre
246 Clayton rd, Clayton Vic 3168
Country 91950 0
Australia
Phone 91950 0
+61 3 9594 5500
Fax 91950 0
Email 91950 0
Julian.Smith@monash.edu
Contact person for public queries
Name 91951 0
Madhu Neeli
Address 91951 0
QHeart Medical (BioQ Devices Pty Ltd)
Suite 3, 52 High street, Toowong, QLD 4066
Country 91951 0
Australia
Phone 91951 0
+61403546511
Fax 91951 0
Email 91951 0
madhu@qheartmedical.com
Contact person for scientific queries
Name 91952 0
Peter Walsh
Address 91952 0
QHeart Medical (BioQ Devices Pty Ltd)
Suite 3, 52 High street, Toowong, QLD 4066
Country 91952 0
Australia
Phone 91952 0
+61405173832
Fax 91952 0
Email 91952 0
peter@qheartmedical.com

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


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.