An interventional study of Physiologic Pacemaker Programming and Standard Pacemaker Programming in Symptomatic Bradycardia, Cognitive Function and Pacemaker, sponsored by University of Minnesota. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment
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 bradycardia will be screened before device implantation. Interested and eligible patients will provide written informed consent before any study-specific procedures are performed.
Baseline cognitive and health-status assessments will be completed before pacemaker implantation. Cognitive function will be assessed using the Montreal Cognitive Assessment, a brief standardized screening instrument that evaluates multiple cognitive domains, including memory, attention, language, visuospatial ability, executive function, and orientation. Health status and functional well-being will be assessed using the SF-36 questionnaire, including the mental component summary score.
Participants will be randomized to either standard pacing at 60 beats per minute or individualized physiologic rate pacing between 60 and 90 beats per minute using the myPACE algorithm. Follow-up Montreal Cognitive Assessment and SF-36 assessments will be repeated at the routine 3-month pacemaker clinic visit to evaluate changes in cognitive performance and health status between the pacing strategies.
317 studies on the registry are indexed under Bradycardia; 71 are open to participants now.
This study's planned enrollment of 110 is close to the median of 100 across 187 interventional studies indexed under Bradycardia.
Browse Bradycardia studies →University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
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- Patient requiring a pacemaker for bradycardia
Exclusion Criteria:
Participants randomized to this arm will receive standard pacemaker programming with a lower pacing rate of 60 beats per minute after permanent pacemaker implantation for bradycardia.
Device: Standard Pacemaker Programming
Participants randomized to this arm will receive individualized physiologic pacemaker programming between 60 and 90 beats per minute using the myPACE algorithm after permanent pacemaker implantation for bradycardia.
Device: Physiologic Pacemaker Programming
Individualized physiologic pacemaker programming between 60 and 90 beats per minute will be performed using the myPACE algorithm.
Also known as: myPACE Algorithm
Standard pacemaker programming with a lower pacing rate of 60 beats per minute will be used after permanent pacemaker implantation.
Change in Montreal Cognitive Assessment Total Score
Change in Montreal Cognitive Assessment total score from baseline to 3 months after pacemaker implantation will be compared between participants randomized to standard pacemaker programming at 60 beats per minute and participants randomized to physiologic pacemaker programming between 60 and 90 beats per minute using the myPACE algorithm. The Montreal Cognitive Assessment is scored from 0 to 30, with higher scores indicating better cognitive function.
Time frame: Baseline to 3 months after pacemaker implantation
Change in Short Form 36 Health Survey Mental Component Summary Score
Change in Short Form 36 Health Survey Mental Component Summary score from baseline to 3 months after pacemaker implantation will be compared between participants randomized to standard pacemaker programming at 60 beats per minute and participants randomized to physiologic pacemaker programming between 60 and 90 beats per minute using the myPACE algorithm. The Short Form 36 Health Survey Mental Component Summary score ranges from 0 to 100, with higher scores indicating better mental health and psychological well-being.
Time frame: Baseline to 3 months after pacemaker implantation
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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