NCT04721314

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: University of Vermont · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pacemaker
• Diastolic Dysfunction
• Diastolic Heart Failure

Interventions

Type	Name	Description
DEVICE	Adjustment of lower rate limit	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.
DEVICE	Maintenance of lower rate limit	Lower rate limit will be maintained at 60 beats-per-minute

Timeline

• Start date: 2019-07-17
• Primary completion: 2021-10-30
• Completion: 2021-12-05
• First posted: 2021-01-22
• Last updated: 2022-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study