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PACE Cognition Proof-of-Concept Study
Sponsor: University of Minnesota
Summary
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.
Official title: Impact of Physiologic Pacemaker Programming on Cognitive Function and Health Status in Patients With Symptomatic Bradycardia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2026-10-01
Completion Date
2028-10-01
Last Updated
2026-08-18
Healthy Volunteers
No
Interventions
Physiologic Pacemaker Programming
Individualized physiologic pacemaker programming between 60 and 90 beats per minute will be performed using the myPACE algorithm.
Standard Pacemaker Programming
Standard pacemaker programming with a lower pacing rate of 60 beats per minute will be used after permanent pacemaker implantation.
Locations (2)
M Health Fairview Clinics and Surgery Center
Minneapolis, Minnesota, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States