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.

Not Applicable

Recruiting

• Conditions: Cardiac Pacing; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12620000149965
• Lead Sponsor: Dennis Lau

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-12
• Last Update Posted: 6 June 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 35

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[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.]