None listed
Conditions
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.
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 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 mo
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.
Sponsors
Dennis Lau
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed