Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04721314
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2021-01-16
Brief Title:
Personalized Pacing A New Paradigm for Patients With Diastolic Dysfunction or Heart Failure With Preserved Ejection Fraction
Sponsor:
University of Vermont
Organization:
University of Vermont
Study Overview
Official Title:
Personalized Pacing A New Paradigm for Patients With Diastolic Dysfunction or Heart Failure With Preserved Ejection Fraction
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
myPACE
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None