Physiologic Pacemaker Programming for Slow Heart Rate
What You Need to Know Before You Apply
What is the purpose of 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.
Who Is on the Research Team?
Selma Carlson, MD
Principal Investigator
University of Minnesota
Markus Meyer, MD
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for adults with symptoms from a slow heart rate (bradycardia) who need a permanent pacemaker. Participants should be able to complete cognitive and health assessments before and after getting the pacemaker.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline cognitive and health-status assessments are completed before pacemaker implantation
Treatment
Participants receive pacemaker implantation and are randomized to either standard or physiologic pacemaker programming
Follow-up
Follow-up assessments of cognitive function and health status at the 3-month pacemaker clinic visit
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares two ways of setting up pacemakers: standard programming at a steady 60 beats per minute versus personalized pacing that adjusts between 60–90 beats per minute using an algorithm. People are randomly assigned to one group or the other.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
Medtronic
Industry Sponsor
Geoff Martha
Medtronic
Chief Executive Officer since 2020
Finance degree from Penn State University
Dr. Richard Kuntz
Medtronic
Chief Medical Officer since 2023
MD, MSc
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