Health TrialsbyHealthPanel

PACE Cognition Proof-of-Concept Study

ConditionsSymptomatic BradycardiaCognitive FunctionPacemakerHealth Status
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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Vulnerable adult unable to give consent

Unable to answer questionnaire

Children

Pregnant women/persons

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Standard Pacemaker ProgrammingActive comparator 1 intervention
Group B: Physiologic Pacemaker ProgrammingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Montreal Cognitive Assessment Total Score

Change in Montreal Cognitive Assessment total score from baseline to 3 months after pacemaker implantation will be compared between participants randomized to standard pacemaker programming at 60 beats per minute and participants randomized to physiologic pacemaker programming between 60 and 90 beats per minute using the myPACE algorithm. The Montreal Cognitive Assessment is scored from 0 to 30, with higher scores indicating better cognitive function.

Time frame
Baseline to 3 months after pacemaker implantation

Secondary outcomes

1

Change in Short Form 36 Health Survey Mental Component Summary Score

Change in Short Form 36 Health Survey Mental Component Summary score from baseline to 3 months after pacemaker implantation will be compared between participants randomized to standard pacemaker programming at 60 beats per minute and participants randomized to physiologic pacemaker programming between 60 and 90 beats per minute using the myPACE algorithm. The Short Form 36 Health Survey Mental Component Summary score ranges from 0 to 100, with higher scores indicating better mental health and psychological well-being.

Time frame
Baseline to 3 months after pacemaker implantation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Medtronic

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: