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PACE Cognition Proof-of-Concept Study

NCT07769424 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-08-19

No results posted yet for this study

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.

Conditions

  • Symptomatic Bradycardia
  • Cognitive Function
  • Pacemaker
  • Health Status

Interventions

DEVICE

Physiologic Pacemaker Programming

Individualized physiologic pacemaker programming between 60 and 90 beats per minute will be performed using the myPACE algorithm.

DEVICE

Standard Pacemaker Programming

Standard pacemaker programming with a lower pacing rate of 60 beats per minute will be used after permanent pacemaker implantation.

Sponsors & Collaborators

Principal Investigators

  • Selma Carlson, MD · University of Minnesota

  • Markus Meyer, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2028-10-01
Completion
2028-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07769424 on ClinicalTrials.gov