About this trial
This proof-of-concept study will evaluate whether physiologic pacemaker programming improves cognitive function and health status in patients with symptomatic bradycardia who require permanent pacemaker implantation.
Participants will be randomized to either standard pacemaker programming at 60 beats per minute or individualized physiologic rate pacing between 60 and 90 beats per minute using the myPACE algorithm. Cognitive function and health status will be assessed before pacemaker implantation and again at the routine 3-month pacemaker clinic visit.
The primary outcome is change in Montreal Cognitive Assessment total score. The secondary outcome is change in SF-36 mental component summary score.
Eligibility criteria
Qualifiers
None
Disqualifiers
Vulnerable adult unable to give consent
Unable to answer questionnaire
Children
Pregnant women/persons
Trial design
Treatments tested in this trial
- Physiologic Pacemaker Programming
- Standard Pacemaker Programming
Treatment groups
Sponsors and collaborators
University of Minnesota
Lead sponsor
Medtronic
Collaborator