None listed
Conditions
Brief summary
For many years the standard approach to lead placement has been the right ventricular apex (RVA). However, early evidence suggests that right ventricular high septum (RVHS) pacing may be more beneficial compared to RVA pacing. Patients with complete heart block requiring more than 90% ventricular pacing will be randomised into two groups; RVA vs RVHS pacing. The two pacing modalities will be compared to assess left ventricular function as measured by the left ventricular ejection fraction.
Interventions
Implant of pacemaker and lead system. Results after a follow-up period of 24 months will be compared between right ventricular apex (RVA) vs right ventricular high septum (RVHS) lead placement. At the end of the study the treatment continues.
Right ventricular apex: Area at the base of the right ventricle in the heart.
Right ventricular high septum: Area near the top of the right ventricle closer to the middle of the heart.
Sponsors
Medtronic Australasia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to -2147483648 No limit
Healthy volunteers
No
Inclusion criteria
Patients diagnosed with high-grade A-V block scheduled to undergo pacemaker implantation.
Exclusion criteria
Patient with intermittent AV block or scheduled for Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy.
Outcome results
None listed