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Trial registered on ANZCTR


Registration number
ACTRN12619001613190p
Ethics application status
Not yet submitted
Date submitted
28/10/2019
Date registered
22/11/2019
Date last updated
22/11/2019
Date data sharing statement initially provided
22/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial Comparing Conventional and Newer, Physiological Pacing Techniques
Scientific title
HISPACE: A Randomised Controlled Trial Comparing Right Ventricular Pacing with Physiological Pacing
Secondary ID [1] 299661 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arrhythmia 314996 0
Atrioventricular conduction disease 314997 0
Condition category
Condition code
Cardiovascular 313333 313333 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in the interventional arm will undergo implantation of pacemaker using the His-lead instead of conventional 5076 lead, via standard of care venous (subclavian or axillary) access. This procedure will be performed by electrophysiologist, and is a once off procedure (not recurring). This procedure will be performed in fully-functional cardiac catheterisation laboratory, where pacemakers are routinely inserted. The procedure takes approximately 30 minutes. The implanted pacemakers are permanent systems (lifelong), however depending on clinical circumstances an upgrade to biventricular pacemaker may be performed if a clinical indication is met.
Intervention code [1] 315923 0
Treatment: Devices
Comparator / control treatment
Patients in the control arm will undergo implantation of conventional 5076 lead in the right ventricle, via standard of care venous (subclavian or axillary) access. This procedure will be performed by electrophysiologist, and is a once off procedure (not recurring). This procedure will be performed in fully-functional cardiac catheterisation laboratory, where pacemakers are routinely inserted.
Control group
Active

Outcomes
Primary outcome [1] 321814 0
Composite outcome of all-cause mortality, hospitalisation rate for heart failure (HFH), left ventricular ejection fraction (LVEF), and need for upgrade to biventricular pacing systems. Specifically, mortality and hospitalisation rates will be audited through follow-up visits, assessment of left ventricular ejection function through assessment using cardiac echocardiography, and need for upgrade to biventricular pacing systems through clinical assessment of patient at each follow-up visit.
Timepoint [1] 321814 0
Outcomes will be assessed on Day 1 post-pacemaker implantation, and thereafter in month 3, 6, and 12, with a window period of 2-4 weeks, as described in the study protocol.
Secondary outcome [1] 376292 0
Acute His-lead dislodgement assessed by loss of function of the implanted pacemaker lead
Timepoint [1] 376292 0
30-day, 3-month, 6-month and 12-month post-pacemaker implantation
Secondary outcome [2] 376293 0
Device-related wound infection assessed by local wound inspection, or presentation to hospital with infective symptoms
Timepoint [2] 376293 0
30-day, 3-month, 6-month and 12-month post-pacemaker implantation

Eligibility
Key inclusion criteria
Above 18 years of age
Has an indication for pacemaker device for atrioventricular conduction abnormality.
Minimum age
19 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Presence of co-morbidities limiting life expectancy <1 year (eg incurable malignancy in the last 5 years, severe COPD)
- Patients perceived to have a reversible cause for cardiomyopathy or conduction defect (eg viral cardiomyopathy, Takotsubo cardiomyopathy)
- Renal impairment eGFR <20
- Patients with previous TAVI or aortic valve or root surgery
- Patients currently involved in a concurrent drug or device trial
- Patients with an existing cardiac device
- Patients with past history of infected cardiac device, or infective endocarditis

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 304129 0
Hospital
Name [1] 304129 0
Northern Health
Address [1] 304129 0
185 Cooper Street Epping VIC 3076
Country [1] 304129 0
Australia
Primary sponsor type
Hospital
Name
Northern Health
Address
185 Cooper Street Epping 3076 VIC
Country
Australia
Secondary sponsor category [1] 304365 0
None
Name [1] 304365 0
Address [1] 304365 0
Country [1] 304365 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 304615 0
St Vincent's Human Research and Ethics Committee
Ethics committee address [1] 304615 0
St. Vincent’s Hospital Melbourne
Research Governance Unit (RGU), PO Box 2900
Fitzroy, 3065 VIC
Ethics committee country [1] 304615 0
Australia
Date submitted for ethics approval [1] 304615 0
27/11/2019
Approval date [1] 304615 0
Ethics approval number [1] 304615 0

Summary
Brief summary
This study examines the difference between implanting a conventional pacemaker and a novel technique in pacemaker implantation where the pacing lead is implanted in the His-bundle region of the heart. This novel technique could circumvent the known adverse effects of conventional pacemakers, and result in improved patient outcomes. His-bundle pacemaker is hypothesised to result in improved cardiac function compared to conventional pacemakers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97594 0
A/Prof Uwais Mohamed
Address 97594 0
Department of Cardiology, Northern Hospital, 185 Cooper Street Epping VIC 3076
Country 97594 0
Australia
Phone 97594 0
+61 3 8405 8000
Fax 97594 0
Email 97594 0
uwais.mohamed@nh.org.au
Contact person for public queries
Name 97595 0
Dr Dominic Chow
Address 97595 0
Department of Cardiology, Northern Hospital, 185 Cooper Street Epping VIC 3076
Country 97595 0
Australia
Phone 97595 0
+61 3 8405 8000
Fax 97595 0
Email 97595 0
cl.chow@unimelb.edu.au
Contact person for scientific queries
Name 97596 0
Dr Dominic Chow
Address 97596 0
Department of Cardiology, Northern Hospital, 185 Cooper Street Epping VIC 3076
Country 97596 0
Australia
Phone 97596 0
+61 3 8405 8000
Fax 97596 0
Email 97596 0
cl.chow@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will only be provided to scientific/ ethical reviewing bodies upon request to maintain anonymity and privacy of enrolled subjects. IPD will not be made publicly available.
What supporting documents are/will be available?
No other documents available
Summary results
No Results