PACE Cognition Proof-of-Concept Study

Conditions: Symptomatic Bradycardia, Cognitive Function, Pacemaker, Health Status

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: NA

Enrollment: 110

Sponsor: University of Minnesota

Location: M Health Fairview Clinics and Surgery Center Minneapolis 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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07769424). StuddyBuddy aggregates publicly available trial information.