MedTrace Logo

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

NCT02586480 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 848

Last updated 2017-10-18

No results posted yet for this study

Summary

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

Conditions

  • Sinus Node Dysfunction
  • Atrioventricular Block

Interventions

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.

Sponsors & Collaborators

  • LivaNova

    lead INDUSTRY

Principal Investigators

  • Jérôme TAIEB, MD · CH du Pays d'Aix - Aix en Provence

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-11-30
Completion
2015-12-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02586480 on ClinicalTrials.gov