RecruitingACTRN12620000149965

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.

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


Sponsor

Dennis Lau

Enrollment

35 participants

Start Date

Mar 12, 2020

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Some people with heart rhythm problems need a pacemaker to help their heart beat properly. Traditional pacemakers stimulate the heart from the right ventricle — a location that does not perfectly mimic the heart's natural electrical pathway, which can sometimes cause the heart muscle to work less efficiently over time. Newer pacemakers can place the lead at a site called the His-Purkinje system, which is closer to the heart's natural wiring, producing what is called 'physiological pacing'. This study is using a specialised ultrasound technique called Global Longitudinal Strain (GLS) to measure how well the heart muscle contracts under physiological pacing. GLS is more sensitive than standard echocardiography and can detect subtle differences in heart function that might otherwise be missed. You may be eligible if you already have a cardiac implant device with a lead placed in the His-Purkinje system, and that lead is working and programmable. You must also be able to have a standard echocardiogram. People with severe valvular heart disease, significant heart failure, or pregnancy are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 performa

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.


Locations(1)

The Royal Adelaide Hospital - Adelaide

SA, Australia

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