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

October 16, 2017 updated by: LivaNova

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

848

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix-en-Provence, France
        • CH du Pays d'Aix
      • Alençon, France
        • CH Alençon
      • Alès, France
        • Cabinet Alès
      • Amiens, France
        • Hopital Sud
      • Annecy, France
        • CH Annecy
      • Antony, France
        • Hopital Prive Antony
      • Argenteuil, France
        • Hopital d'Argenteuil
      • Bordeaux, France
        • Hopital St André
      • Bourges, France
        • CH Bourges
      • Brest, France
        • Chu Brest
      • Brest, France
        • Clinique Keraudren
      • Caen, France
        • CHU Caen
      • Calais, France
        • Clinique Des 2 Caps
      • Chartres, France
        • CH Chartres
      • Chaumont, France
        • Ch Chaumont
      • Cherbourg, France
        • Cabinet Cherbourg
      • Clamart, France
        • HIA Percy
      • Colmar, France
        • Hôpital L. Pasteur
      • Corbeil Essonnes, France
        • CH Corbeil Essonnes
      • Creutzwald, France
        • Cabinet Creutzwald
      • Créteil, France
        • Hôpital Henri Mondor
      • Dinan, France
        • CH DINAN
      • Douarnenez, France
        • Ch Douarnenez
      • Evreux, France
        • CH Evreux
      • Evry, France
        • CMCO Evry
      • Forbach, France
        • Cabinet Forbach
      • Forbach, France
        • Ch Forbach
      • Haguenau, France
        • CH Haguenau
      • Helfaut, France
        • CH Helfaut
      • Lannion, France
        • Ch Lannion
      • Le Havre, France
        • CH Le Havre
      • Le Mans, France
        • CMCM Le Mans
      • Le Port-Marly, France
        • CMC Port Marly
      • Lomme, France
        • CH Lomme
      • Lorient, France
        • CH Lorient
      • Marseille, France
        • CHU La Timone
      • Marseille, France
        • Hôpital Nord
      • Melun, France
        • Clinique Melun
      • Metz, France
        • CH Privé Metz
      • Montfermeil, France
        • Ch Montfermeil
      • Montpellier, France
        • Clinique Montpellier
      • Nancy, France
        • Clinique A. Paré
      • Nantes, France
        • NCN Nantes
      • Orléans, France
        • CH Orleans
      • Paris, France
        • Cabinet Paris
      • Paris, France
        • CH St Joseph
      • Poissy, France
        • CH Poissy st Germain
      • Poitiers, France
        • CHU Poitiers
      • Rouen, France
        • Clinique St Hilaire
      • Saint Denis, France
        • CCN St Denis
      • Saint Nazaire, France
        • CH ST Nazaire
      • Sens, France
        • CH Sens
      • St Malo, France
        • Ch St Malo
      • Thionville, France
        • CH Thionville
      • Valenciennes, France
        • CH Valenciennes
      • Valognes, France
        • Cabinet Valognes
      • Villefranche Sur Saone, France
        • CH Villefrance
    • Guadeloupe
      • Terre Basse, Guadeloupe, France
        • CH Basse Terre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Bradycardia patients eligible for dual chamber pacemaker implantation for SND, AVBI or AVBII

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LivaNova

Investigators

  • Principal Investigator: Jérôme TAIEB, MD, CH du Pays d'Aix - Aix en Provence

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

October 23, 2015

First Posted (Estimate)

October 26, 2015

Study Record Updates

Last Update Posted (Actual)

October 18, 2017

Last Update Submitted That Met QC Criteria

October 16, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBSY02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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