NCT02586480

Evolution of the PR Interval in Patients Implanted With a Pacemaker Using the SafeR Mode

Evolution of the PR Interval in Patients Implanted With a Dual Chamber Pacemaker With Algorithm for Spontaneous AV Conduction Preservation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 848 (actual)
• Sponsor: LivaNova · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Observational study on long PR interval using the SafeR mode in bradycardia patients.

Detailed description

This observational trial aims to study the evolution of the PR interval in patients implanted with a dual chamber pacemaker with the SafeR mode. The investigators will assess the prevalence and the incidence of PR lengthening and the investigators will study the long PR interval management by physicians, depending on the data embedded in the pacemaker.

Conditions

• Sinus Node Dysfunction
• Atrioventricular Block

Interventions

Type	Name	Description
DEVICE	dual chamber pacemaker with SafeR algorithm	SafeR is an AVB management algorithm: it provides AAI pacing while continuously monitoring AV conduction, it switches to DDD when detecting AVB I, II or III, according to the following criteria: (1) AVB I: 6 long PR intervals, (2) AVB II: 3 blocked atrial events/12 cycles, (3) AVB III: 2 consecutive blocked atrial events. It switches back to AAI mode when needed.

Timeline

• Start date: 2012-04-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2015-10-26
• Last updated: 2017-10-18

Locations

58 sites across 1 country: France