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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 is a NA study that has completed, run by University of Vermont. The registered enrollment target is 123 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04721314
The ClinicalTrials.gov registry entry for NCT04721314 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Vermont, which has 162 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Adjustment of lower rate limit is the first listed.
NCT04721314 reports 0 study locations.
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.
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