CClinicalTrials.gg
CompletedNCT00531037NATUREUpdated Nov 14, 2017

Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers

An observational study in Patients Implanted With a Pacemaker, sponsored by LivaNova. Completed at 129 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-14.

Sponsored by LivaNova · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,440
Ages
18 Years and older
Sex
All
01

Study summary

Observational study to assess AV block incidence and their evolution according to paroxysmal atrial arrhythmia.

02

Conditions studied

  • Patients Implanted With a Pacemaker

Keywords

  • AV block, SND, BTS, AAIsafeR, SafeR, PM implanted
03

In context

Cardiac Conduction System Disease

34 studies on the registry are indexed under Cardiac Conduction System Disease; 9 are open to participants now.

This study's enrollment of 1,440 is above the median of 705 across 18 observational studies indexed under Cardiac Conduction System Disease.

Browse Cardiac Conduction System Disease studies →

Lead sponsor

LivaNova is the lead sponsor of 39 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient primo-implanted with a pacemaker (Symphony ™ DR2550, Symphony ™ D 2450, Reply DR, Reply D or any similar or higher range) device less than three months ago, programmed in SafeR mode.

Inclusion criteria

  • Sinus Node Disease
  • Brady-Tachy Syndrome
  • Suspected or documented paroxysmal AVB

Exclusion criteria

Exclusion Criteria:

  • Permanent high degree AVB
  • Contra indication to the SafeR pacing mode
  • PR higher than 350 ms
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,440 participants (actual)
06

What researchers measure

Primary outcomes

  1. High degree AV blocks

    Time frame: 2 years

07

Study locations

129 sites
  • Baptist Princeton Birmingham
    Birmingham, Alabama, United States
  • Tennessee Valley Sheffield
    Sheffield, Alabama, United States
  • Cardiovascular Assoc. Of Mesa
    Mesa, Arizona, United States
  • O'Connor Hospital San Jose
    San Jose, California, United States
  • Piedmont hospital
    Piedmont, Georgia, United States
  • University of Mississippi Medical Center
    Mississippi, Mississippi, United States
  • St. Francis Hospital Tulsa
    Tulsa, Oklahoma, United States
  • Az St- Blasius
    Dendermonde, Belgium
  • Ch de Huy
    HUY, Belgium
  • Heilig Hart Ziekenhuis MOL
    MOL, Belgium
  • Hospital Hamilton
    Hamilton, Canada
  • Niagara Health System
    Niagara, Canada
  • Bispebjerg Hospital
    Bispebjerg, Denmark
  • HELLERUP
    Gentofte Hospital, Denmark
  • Clinique Esquirol
    Agen, France
  • CH Albi
    Albi, France
  • Clinique Claude Bernard
    Albi, France
  • CH ALES
    Ales, France
  • Clinique Bonnefond
    Ales, France
  • Cabinet Prive
    Annecy, France
  • Clinique Aressy
    Aressy, France
  • CH AUCH
    Auch, France
  • Clinique Paulmy
    Bayonne, France
  • Ch Beauvais
    Beauvais, France
  • Clinique St Vincent
    Besancon, France
  • Ch Beziers
    Beziers, France
  • Clinique Aguilera
    Biarritz, France
  • Chu Pessac
    Bordeaux, France
  • Clinique Des Pins Francs
    Bordeaux, France
  • Ch Boulogne
    Boulogne Sur Mer, France
  • Chu Brest
    Brest, France
  • CH BRIVE
    Brive, France
  • Ch Calais
    Calais, France
  • Clinique Des 2 Caps
    Calais, France
  • Ch Carcassonne
    Carcassonne, France
  • Chu Ceret
    Ceret, France
  • Ch Chalons
    Chalons En Champagne, France
  • Clinique Bon Secours
    Chatellerault, France
  • Ch Chaumont
    Chaumont, France
  • Ch Cherbourg
    Cherbourg, France
  • Ch Colmar
    Colmar, France
  • Cabinet Cardiologie Creutzwald
    Creutzwald, France
  • Polyclinique Du Parc
    Croix, France
  • CH DINAN
    Dinan, France
  • CH DOLE
    Dole, France
  • CH DOUAI
    Douai, France
  • Ch Douarnenez
    Douarnenez, France
  • Polyclinique Notre Dame
    Draguignan, France
  • Hôpital Emile Roux
    Eaubonne, France
  • Centre Cardiologique D'Evecquemont
    Evecquemont, France
  • Hôpital D'Evreux
    Evreux, France
  • Ch Firminy
    Firminy, France
  • Ch Forbach
    Forbach, France
  • Ch Freyming
    Freyming Merlebach, France
  • CH GAP
    GAP, France
  • Ch Lannion
    Lannion, France
  • Cmc Parly Ii
    Le Chesnay, France
  • Ch Le Havre
    Le Havre, France
  • Chu Le Havre
    Le Havre, France
  • Hôpital Cardiologique
    Lyon, France
  • Chu La Timone
    Marseille, France
  • Hôpital Nord
    Marseille, France
  • Chg Martigues
    Martigues, France
  • Institut Hospitalier Jacques Cartier
    Massy, France
  • Hôpital Ste Blandine
    Metz, France
  • Clinique Pont Chaume
    Montauban, France
  • Hôpital Le Raincy Monfermeil
    Montfermeil, France
  • Chu Montpellier
    Montpellier, France
  • Clinique Plein Ciel
    Mougins, France
  • Ch Moulins
    Moulins, France
  • Clinique Du Diaconnat
    Mulhouse, France
  • Centre Chirurgical Ambroise Pare
    Neuilly Sur Seine, France
  • Ch Nevers
    Nevers, France
  • Clinique Des Fleurs
    Ollioules, France
  • Ch Orange
    Orange, France
  • Clinique Bizet
    Paris, France
  • Clinique Parc Monceau
    Paris, France
  • Hôpital Val de Grâce
    Paris, France
  • CHU PAU
    PAU, France
  • Ch Perpignan
    Perpignan, France
  • Chu Poitiers
    Poitiers, France
  • Centre Medico Chirurgical de L'Europe
    PORT Marly, France
  • Hôpital Prive Claude Galien
    Quincy Sous Senart, France
  • Clinique Pasteur
    Ris Orangis, France
  • CH RODEZ
    Rodez, France
  • Clinique St Hilaire Rouen
    Rouen, France
  • Polyclinique de Montier La Celle
    Saint André Les Vergers, France
  • Clinique Notre Dame
    Saint Die Des Vosges, France
  • Hôpital Prive Nord Parisien
    Sarcelles, France
  • Centre Cardiologique Du Nord
    St Denis, France
  • Ch St Malo
    St Malo, France
  • Cmc Ste Feyre
    STE Feyre, France
  • Clinique St Gatien
    Tours, France
  • Clinique Vauban
    Valenciennes, France
  • Erzgebirgsklinikum ANNABERG
    Annaberg, Germany
  • Schade Stolz Rötech
    Berlin, Germany
  • Klinikum Bogenhausen
    Bogenhausen, Germany
  • Klinikum Dresden
    Dresden, Germany
  • PRAXIS Dr Subin und Lutter
    Hamburg, Germany
  • Hospital Montebelluna
    Montebelluna, Italy

Showing the first 100 of 129 sites across 11 countries.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00531037
Lead sponsor
LivaNova
Responsible party
Sponsor
First posted
Sep 18, 2007
Start date
Jun 2007
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Nov 14, 2017

Study contacts

DEHARO Jean Claude, MD
principal investigator · CHU la Timone - Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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