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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational [Patient Registry]

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

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

Detailed Summary: 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.
Sponsor: LivaNova

Current Primary Outcome: Prolonged PR interval (> 200ms) in patients without AVB I at baseline (Incidence of "clinical" AVB1) [ Time Frame: at 12 months ]

This incidence will be measured using PR/AR histograms stored in the device memory


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: LivaNova

Dates:
Date Received: October 23, 2015
Date Started: April 2012
Date Completion: December 2015
Last Updated: October 23, 2015
Last Verified: October 2015