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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02586480

Acronym

PRECISE

Enrollment

848

Registered

2015-10-26

Start date

2012-04-30

Completion date

2015-12-31

Last updated

2017-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrioventricular Block, Sinus Node Dysfunction

Keywords

bradycardia

Brief 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.

Interventions

DEVICEdual 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient implanted (primo-implant, replacement, upgrade) with a Sorin Group™ dual chamber pacemaker according to current available guidelines and IFU from less than three months. * Since implantation, the device is programmed in SafeR mode * Patient agreed to participate, after having received the appropriate and mandatory information

Exclusion criteria

* Patient contraindicated for cardiac pacing, according to current available guidelines * Permanent atrial fibrillation * Permanent high-degree AV block * Patient not available for routine follow-up visits * Patient already included in another clinical study * Inability to understand the purpose of the study / refusal to cooperate * minor age * Pregnancy * Life expectancy less than 12 months * Under guardianship

Design outcomes

Primary

Measure	Time frame	Description
Prolonged PR interval (> 200ms) in patients without AVB I at baseline (Incidence of clinical AVB1)	at 12 months	This incidence will be measured using PR/AR histograms stored in the device memory

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026