University of Minnesota
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.
Cardiac pacing may improve cognition by restoring physiologic heart rates, enhancing cerebral perfusion, and improving overall cardiovascular function in patients with symptomatic bradycardia who require permanent pacemaker implantation. In current clinical practice, the lower pacing rate is commonly programmed to 60 beats per minute, which is below the normal resting heart rate in many adults. PACE Cognition is a proof-of-concept study evaluating the impact of physiologic pacemaker programming on cognitive function and health status. Patients requiring permanent pacemaker implantation for br…
Inclusion Criteria: \- Patient requiring a pacemaker for bradycardia Exclusion Criteria: * Vulnerable adult unable to give consent * Unable to answer questionnaire * Children * Pregnant women/persons * Prisoners * Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent * Non-English speakers * Individuals unable to read * Employees or students of the researcher * Active members of the military or DoD personnel
Individualized physiologic pacemaker programming between 60 and 90 beats per minute will be performed using the myPACE algorithm.
Standard pacemaker programming with a lower pacing rate of 60 beats per minute will be used after permanent pacemaker implantation.
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