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NCT04721314 · ClinicalTrials.gov registry record · NA
Personalized Pacing: A New Paradigm for Patients With Diastolic Dysfunction or Heart Failure With Preserved Ejection Fraction
A NA study, sponsored by University of Vermont.
- Completed
- Registry status
- NA
- Development phase
- 123
- Enrollment target
NCT04721314: Completed NA study, sponsored by University of Vermont.
NCT04721314 is a NA study that has completed, run by University of Vermont. The registered enrollment target is 123 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04721314, a NA study, has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- NA
- Development phase
- 123 participants
- Enrollment target
Study 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.
Primary Outcome
Change in score from baseline (at enrollment) to 1 month and 12 months after enrollment.
Interventions
- DEVICE Adjustment of lower rate limit
- DEVICE Maintenance of lower rate limit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2019-07-17 |
| Est. Completion | 2021-12-05 |
| Phase | NA |
What the finished NCT04721314 record still lists
NCT04721314 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Adjustment of lower rate limit is the first listed.
NCT04721314 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04721314 about?
NCT04721314 is a clinical study titled "Personalized Pacing: A New Paradigm for Patients With Diastolic Dysfunction or Heart Failure With Preserved Ejection Fraction". 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 rand...
What is the current status of trial NCT04721314?
This trial is currently completed. It is a NA study. The enrollment target is 123 participants. The study started on 2019-07-17. Estimated completion is 2021-12-05.
What interventions are being tested in trial NCT04721314?
The interventions under investigation include: Adjustment of lower rate limit (DEVICE), Maintenance of lower rate limit (DEVICE).
Who is sponsoring clinical trial NCT04721314?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04721314's enrollment target sits among peer trials
123 762nd of 2000 higher than 1,239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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