Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05766462
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2023-02-20
Brief Title:
Allometric-Pace Study
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
Utilization of Personalized Pacing to Improve Quality of Life in Sinus Node Dysfunction Patients
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
The goal of this observational study is to improve quality of life in sinus node dysfunction patients by utilizing allometric lower rate pacing or called personalized lower rate PLR in standard commercially available dual-chamber pacemakers
The primary objective is to achieve a significant improvement in patients quality of life with use of PLR pacing in comparison with the control group with nominal lower rate in patients with implanted dual-chamber pacemaker
The secondary objectives are to assess cardiac functional changes in echocardiography of ventricular mechanical performance with a PLR pacing in comparison with the control group with nominal lower rate and to assess the viability of using elevated blood pressure as a marker for undetected bradycardia and providing allometric rate to correct bradycardia-related increase in arterial systolic blood pressure
The primary objective is to achieve a significant improvement in patients quality of life with use of PLR pacing in comparison with the control group with nominal lower rate in patients with implanted dual-chamber pacemaker
The secondary objectives are to assess cardiac functional changes in echocardiography of ventricular mechanical performance with a PLR pacing in comparison with the control group with nominal lower rate and to assess the viability of using elevated blood pressure as a marker for undetected bradycardia and providing allometric rate to correct bradycardia-related increase in arterial systolic blood pressure
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None