PACE Cognition Proof-of-Concept Study

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT07769424
Status
Not Yet Recruiting

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Conditions

  • Cognitive Function
  • Health Status
  • Pacemaker
  • Symptomatic Bradycardia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Physiologic Pacemaker Programming — DEVICE
    Individualized physiologic pacemaker programming between 60 and 90 beats per minute will be performed using the myPACE algorithm.
  • Standard Pacemaker Programming — DEVICE
    Standard pacemaker programming with a lower pacing rate of 60 beats per minute will be used after permanent pacemaker implantation.

Study Details

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.

Key Dates

First listed
Aug 18, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Oct 1, 2028
Completion
Oct 1, 2028

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Pacemaker Programming
    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.
  • Experimental: Physiologic 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.

Primary Outcome Measure

Change in Montreal Cognitive Assessment Total Score(MoCA) [ Time Frame: Baseline to 3 months after pacemaker implantation ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
M Health Fairview Clinics and Surgery CenterMinneapolisMinnesota55455
Markus Meyer, MD
[email protected]
612-625-9538
Samantha Wansing
[email protected]
Markus Meyer, MD (PRINCIPAL_INVESTIGATOR)
University of Minnesota Medical CenterMinneapolisMinnesota55455
Markus Meyer, MD
[email protected]
612-625-9538
Markus Meyer, MD (PRINCIPAL_INVESTIGATOR)

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By research site
M Health Fairview Clinics and Surgery Center· Minneapolis, MNUniversity of Minnesota Medical Center· Minneapolis, MN

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