None listed
Conditions
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 and deep septal region of the heart. This novel technique could circumvent the known adverse effects of conventional pacemakers, and result in improved patient outcomes. Conduction system pacemaker is hypothesised to result in improved cardiac function compared to conventional pacemakers.
Interventions
Patients in the interventional arm will undergo implantation of pacemaker using the 3830 lead to capture the conduction system instead 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. The procedure takes ap
Patients in the interventional arm will undergo implantation of pacemaker using the 3830 lead to capture the conduction system instead 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. 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.
Sponsors
Northern Health
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Above 18 years of age Has an indication for pacemaker device for atrioventricular conduction abnormality.
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 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
Outcome results
None listed