CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 123 enrolled
Drug / intervention
Adjustment of lower rate limit +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04721314
NCT04721314N/ACompleted

Personalized Pacing: A New Paradigm for Patients With Diastolic Dysfunction or Heart Failure With Preserved Ejection Fraction

University of Vermont·interventional·Posted Jan 22, 2021·Updated Feb 9, 2022

In Brief

A clinical study evaluating Adjustment of lower rate limit and Maintenance of lower rate limit for Pacemaker and 2 related conditions. Completed, enrolled 123 participants across 1 site.

Detailed Summary

Recent exploratory studies suggest that pacemaker patients with diastolic dysfunction (DD) or heart failure with preserved ejection fraction (HFpEF) may benefit from a higher backup heart rate (HR) setting than the factory setting of 60 beats per minute (bpm). In this prospective double-blinded randomized controlled study, pacemaker patients with DD or overt HFpEF and either 1) intrinsic ventricular conduction or 2) conduction system or biventricular pacing will be enrolled and randomized to either a personalized lower HR setting (myPACE group, based on a height-based HR algorithm) or to the standard 60bpm backup setting (control group) for 1 year.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 22, 2021
Enrollment StartJul 17, 2019
Primary CompletionOct 30, 2021
Study CompletionDec 5, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.4 years ago

Interventions

Adjustment of lower rate limitdevice

Patients with preserved ejection fraction (EF \>50%) and implanted pacemakers will have the lower rate limit adjusted to a personalized heart rate based on a heart rate algorithm.

Maintenance of lower rate limitdevice

Lower rate limit will be maintained at 60 beats-per-minute