PACE Cognition Proof-of-Concept Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota

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

110 Participants
are divided into 2 treatment groups

Sponsors and collaborators