NCT05766462

Allometric-Pace Study

Utilization of Personalized Pacing to Improve Quality of Life in Sinus Node Dysfunction Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 73 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sinus Node Dysfunction

Interventions

Type	Name	Description
OTHER	Pacemaker lower rate setting	Pacemaker lower rate is set by physician and may be adjusted according to the physician diagnosis.

Timeline

• Start date: 2023-03-20
• Primary completion: 2024-11-04
• Completion: 2025-01-31
• First posted: 2023-03-13
• Last updated: 2025-02-07

Locations

3 sites across 1 country: China