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Trial registered on ANZCTR


Registration number
ACTRN12620000149965
Ethics application status
Approved
Date submitted
7/01/2020
Date registered
12/02/2020
Date last updated
2/06/2022
Date data sharing statement initially provided
12/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the performance of a novel cardiovascular implantable electronic device (CIED) capable of natural (physiological) pacing of the heart. A new cardiac ultrasound (echocardiography) analysis technique, known as Global Longitudinal Strain (GLS), will be used to assess the performance of cardiac contraction during this physiologic pacing.
Scientific title
Ventricular myocardial performance of His-purkinje Physiologic Pacing evaluated by Global Longitudinal Strain in patients with a cardiovascular implantable electronic device (CIED): The PP-GLS study
Secondary ID [1] 300035 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
PP-GLS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Pacing 315541 0
Condition category
Condition code
Cardiovascular 313821 313821 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with an implanted physiologic pacemaker will undergo programmed pacing for their device whilst a transthoracic echocardiogram (TTE) ultrasound is performed to collect data on cardiac performance. Participants will be recruited at anytime after the physiologic pacemaker has been implanted (the variable of interest is the ventricular contraction resulting from preferential pacing via programming, not the duration since implant). The A 12-lead electrocardiogram (ECG) will be recorded to monitor cardiac rhythm with ECG electrodes (3M red dots) attached to the participant as per standard ECG protocol. The continuous ECG monitoring will ensure fidelity of the pacing performed and the reliability of intrinsic rhythm.

The pacemaker will be programmed (by an accredited cardiac device specialist technician or electrophysiology cardiologist) to;
- preferential pace the physiologic pacing lead
- preferential pace the other cardiac lead
- preferentially allow intrinsic activation
This will be the same experience a patient would usually have for routine annual device checks when capture thresholds are tested. As beat to beat performance will be evaluated, no 'wash out' period will be required between pacing protocols. TTE ultrasound (performed by a registered medical sonographer) will be performed by routine standard with conventional imaging techniques. The session of data collection (ECG, CIED programming and TTE ultrasound) is expected to last less than 60 minutes and will only be performed for one session.

The ultrasound data will be analyzed after the data collection session has been completed. TTE analysis technique of global longitudinal strain (GLS) will be used to assess the ventricular contraction performance. Pooled analysis of the TTE data will be used to address the study hypothesis.
Intervention code [1] 316308 0
Treatment: Devices
Comparator / control treatment
Patients will act as their own control and their physiologic pacing will be compared to their alternate rhythm (underlying or paced rhythm) by programming of the pacemaker.
Control group
Active

Outcomes
Primary outcome [1] 322220 0
Differences in left ventricular GLS will be compared for physiological pacing compared to standard RV pacing sites. Measurement will be performed by transthoracic echocardiography using Global Longitudinal Strain analysis.
Timepoint [1] 322220 0
Analysis for each participant will be performed at the conclusion of data collection for each participant (immediately post completion of protocol). All measurements will then be pooled at study completion for analysis to answer the hypotheses listed. This will be complete by 24 months from the beginning of participant recruitment.
Secondary outcome [1] 377766 0
Differences in left ventricular GLS will be compared for physiological pacing compared to ventricular activation by normal intrinsic conduction. Measurement will be performed by transthoracic echocardiography using Global Longitudinal Strain analysis.
Timepoint [1] 377766 0
Analysis for each participant will be performed at the conclusion of data collection for each participant (immediately post completion of protocol). All measurements will then be pooled at study completion for analysis to answer the hypotheses listed. This will be complete by 24 months from the beginning of participant recruitment.
Secondary outcome [2] 377767 0
Differences in left ventricular performance will be assessed by routine 2D and 3D TTE assessment of left ventricular ejection fraction for physiological pacing compared to ventricular activation by standard RV pacing sites.
Timepoint [2] 377767 0
Analysis for each participant will be performed at the conclusion of data collection for each participant (immediately post completion of protocol). All measurements will then be pooled at study completion for analysis to answer the hypotheses listed. This will be complete by 24 months from the beginning of participant recruitment.
Secondary outcome [3] 379991 0
Differences in valvular performance will be assessed by routine Doppler evaluation of regurgitation and forward flow for physiological pacing compared to ventricular activation by standard RV pacing sites.
Timepoint [3] 379991 0
Analysis for each participant will be performed at the conclusion of data collection for each participant (immediately post completion of protocol). All measurements will then be pooled at study completion for analysis to answer the hypotheses listed. This will be complete by 24 months from the beginning of participant recruitment.

Eligibility
Key inclusion criteria
• The patient must have a Cardiac Implanted Electronic Device (CIED) with a functioning lead implanted in the His-purkinje system.
• The lead implanted in the His-purkinje system must be programmable and capturing.
• The patient must be suitable for Transthoracic Echocardiography (TTE).
• Able to provide consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to provide written informed consent to participate in this study.
• Participating in another clinical research trial where programming adjustments to the CIED would be unacceptable.
• CIED that does not have a functioning lead implanted in the His-purkinje system.
• Pacing from the CIED is known to cause the patient to become haemodynamically unstable.
• Valvular stenosis or regurgitation of >moderate severity
• Significant cardiomyopathy or advanced heart failure.
• Inability to acquire interpretable echocardiographic images.
• Pregnancy.
• Any medical condition that results in belief (deemed by the Chief Investigators) that it is not appropriate for the patient to participate.

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
Crossover
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
21/02/2020
Actual
12/03/2020
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
31/01/2023
Actual
Sample size
Target
35
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 15574 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 28958 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 304627 0
Self funded/Unfunded
Name [1] 304627 0
Unfunded
Country [1] 304627 0
Primary sponsor type
Individual
Name
Dennis Lau
Address
Royal Adelaide Hospital, Port Rd, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 305141 0
None
Name [1] 305141 0
Address [1] 305141 0
Country [1] 305141 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304920 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 304920 0
Royal Adelaide Hospital
Port Road,
Adelaide SA 5000
Ethics committee country [1] 304920 0
Australia
Date submitted for ethics approval [1] 304920 0
27/10/2019
Approval date [1] 304920 0
01/11/2019
Ethics approval number [1] 304920 0
12198

Summary
Brief summary
The purpose of this study is to investigate the performance of the novel physiologic pacing cardiac implant. Patients with cardiac rhythm disorders may require implantation of a permanent pacemaker (PPM) to stimulate myocardial contraction by leads implanted into the heart. Technology now allows lead implantation at more physiological sites for ventricular activation. The performance of myocardial contraction can be evaluated using transthoracic echocardiography (TTE) with the analysis technique of global longitudinal strain (GLS) which we will utilize to assess patients with physiologic pacing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98646 0
A/Prof Dennis H. Lau
Address 98646 0
Centre for Heart Rhythm Disorders, Royal Adelaide Hospital, Port Rd, Adelaide SA 5000
Country 98646 0
Australia
Phone 98646 0
+61 8 8313 9000
Fax 98646 0
Email 98646 0
[email protected]
Contact person for public queries
Name 98647 0
Dennis H. Lau
Address 98647 0
Centre for Heart Rhythm Disorders, Royal Adelaide Hospital, Port Rd, Adelaide SA 5000
Country 98647 0
Australia
Phone 98647 0
+61 8 8313 9000
Fax 98647 0
Email 98647 0
[email protected]
Contact person for scientific queries
Name 98648 0
Dennis H. Lau
Address 98648 0
Centre for Heart Rhythm Disorders, Royal Adelaide Hospital, Port Rd, Adelaide SA 5000
Country 98648 0
Australia
Phone 98648 0
+61 8 8313 9000
Fax 98648 0
Email 98648 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
Not included in ethics approval


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.