Clinical trial NCT00531037: Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers
Official title: Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Implanted With a Pacemaker
Keywords: AV block, SND, BTS, AAIsafeR, SafeR, PM implanted
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2007-09-18
Enrollment: 1440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: High degree AV blocks
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Baptist Princeton Birmingham
state: Alabama
city: Sheffield
country: United States
facility: Tennessee Valley Sheffield
state: Alabama
city: Mesa
country: United States
facility: Cardiovascular Assoc. Of Mesa
state: Arizona
city: San Jose
country: United States
facility: O'Connor Hospital San Jose
state: California
city: Piedmont
country: United States
facility: Piedmont hospital
state: Georgia
city: Mississippi
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Tulsa
country: United States
facility: St. Francis Hospital Tulsa
state: Oklahoma
city: Dendermonde
country: Belgium
facility: Az St- Blasius
city: HUY
country: Belgium
facility: Ch de Huy
city: MOL
country: Belgium
facility: Heilig Hart Ziekenhuis MOL
city: Hamilton
country: Canada
facility: Hospital Hamilton
city: Niagara
country: Canada
facility: Niagara Health System
city: Bispebjerg
country: Denmark
facility: Bispebjerg Hospital
city: Gentofte Hospital
country: Denmark
facility: HELLERUP
city: Agen
country: France
facility: Clinique Esquirol
city: Albi
country: France
facility: CH Albi
city: Albi
country: France
facility: Clinique Claude Bernard
city: Ales
country: France
facility: CH ALES
city: Ales
country: France
facility: Clinique Bonnefond
city: Annecy
country: France
facility: Cabinet Prive
city: Aressy
country: France
facility: Clinique Aressy
city: Auch
country: France
facility: CH AUCH
city: Bayonne
country: France
facility: Clinique Paulmy
city: Beauvais
country: France
facility: Ch Beauvais
city: Besancon
country: France
facility: Clinique St Vincent
city: Beziers
country: France
facility: Ch Beziers
city: Biarritz
country: France
facility: Clinique Aguilera
city: Bordeaux
country: France
facility: Chu Pessac
city: Bordeaux
country: France
facility: Clinique Des Pins Francs
city: Boulogne Sur Mer
country: France
facility: Ch Boulogne
city: Brest
country: France
facility: Chu Brest
city: Brive
country: France
facility: CH BRIVE
city: Calais
country: France
facility: Ch Calais
city: Calais
country: France
facility: Clinique Des 2 Caps
city: Carcassonne
country: France
facility: Ch Carcassonne
city: Ceret
country: France
facility: Chu Ceret
city: Chalons En Champagne
country: France
facility: Ch Chalons
city: Chatellerault
country: France
facility: Clinique Bon Secours
city: Chaumont
country: France
facility: Ch Chaumont
city: Cherbourg
country: France
facility: Ch Cherbourg
city: Colmar
country: France
facility: Ch Colmar
city: Creutzwald
country: France
facility: Cabinet Cardiologie Creutzwald
city: Croix
country: France
facility: Polyclinique Du Parc
city: Dinan
country: France
facility: CH DINAN
city: Dole
country: France
facility: CH DOLE
city: Douai
country: France
facility: CH DOUAI
city: Douarnenez
country: France
facility: Ch Douarnenez
city: Draguignan
country: France
facility: Polyclinique Notre Dame
city: Eaubonne
country: France
facility: Hôpital Emile Roux
city: Evecquemont
country: France
facility: Centre Cardiologique D'Evecquemont
city: Evreux
country: France
facility: Hôpital D'Evreux
city: Firminy
country: France
facility: Ch Firminy
city: Forbach
country: France
facility: Ch Forbach
city: Freyming Merlebach
country: France
facility: Ch Freyming
city: GAP
country: France
facility: CH GAP
city: Lannion
country: France
facility: Ch Lannion
city: Le Chesnay
country: France
facility: Cmc Parly Ii
city: Le Havre
country: France
facility: Ch Le Havre
city: Le Havre
country: France
facility: Chu Le Havre
city: Lyon
country: France
facility: Hôpital Cardiologique
city: Marseille
country: France
facility: Chu La Timone
city: Marseille
country: France
facility: Hôpital Nord
city: Martigues
country: France
facility: Chg Martigues
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier
city: Metz
country: France
facility: Hôpital Ste Blandine
city: Montauban
country: France
facility: Clinique Pont Chaume
city: Montfermeil
country: France
facility: Hôpital Le Raincy Monfermeil
city: Montpellier
country: France
facility: Chu Montpellier
city: Mougins
country: France
facility: Clinique Plein Ciel
city: Moulins
country: France
facility: Ch Moulins
city: Mulhouse
country: France
facility: Clinique Du Diaconnat
city: Neuilly Sur Seine
country: France
facility: Centre Chirurgical Ambroise Pare
city: Nevers
country: France
facility: Ch Nevers
city: Ollioules
country: France
facility: Clinique Des Fleurs
city: Orange
country: France
facility: Ch Orange
city: Paris
country: France
facility: Clinique Bizet
city: Paris
country: France
facility: Clinique Parc Monceau
city: Paris
country: France
facility: Hôpital Val de Grâce
city: PAU
country: France
facility: CHU PAU
city: Perpignan
country: France
facility: Ch Perpignan
city: Poitiers
country: France
facility: Chu Poitiers
city: PORT Marly
country: France
facility: Centre Medico Chirurgical de L'Europe
city: Quincy Sous Senart
country: France
facility: Hôpital Prive Claude Galien
city: Ris Orangis
country: France
facility: Clinique Pasteur
city: Rodez
country: France
facility: CH RODEZ
city: Rouen
country: France
facility: Clinique St Hilaire Rouen
city: Saint André Les Vergers
country: France
facility: Polyclinique de Montier La Celle
city: Saint Die Des Vosges
country: France
facility: Clinique Notre Dame
city: Sarcelles
country: France
facility: Hôpital Prive Nord Parisien
city: St Denis
country: France
facility: Centre Cardiologique Du Nord
city: St Malo
country: France
facility: Ch St Malo
city: STE Feyre
country: France
facility: Cmc Ste Feyre
city: Tours
country: France
facility: Clinique St Gatien
city: Valenciennes
country: France
facility: Clinique Vauban
city: Annaberg
country: Germany
facility: Erzgebirgsklinikum ANNABERG
city: Berlin
country: Germany
facility: Schade Stolz Rötech
city: Bogenhausen
country: Germany
facility: Klinikum Bogenhausen
city: Dresden
country: Germany
facility: Klinikum Dresden
city: Hamburg
country: Germany
facility: PRAXIS Dr Subin und Lutter
city: Montebelluna
country: Italy
facility: Hospital Montebelluna
city: Negrar
country: Italy
facility: Hospital Negrar
city: Peschiera del Garda
country: Italy
facility: Casa di Cura Pederzoli
city: Kanagawa
country: Japan
facility: Kanagawa Cardiov. and Respiratory Center
city: Kokura
country: Japan
facility: Kokura Memorial Hospital
city: Konan
country: Japan
facility: Konan St Hill Hospital
city: Kyosai
country: Japan
facility: Yokosuka Kyosai General Hospital
city: MIE
country: Japan
facility: Mie University Hospital
city: Nara
country: Japan
facility: Nara Hospital, Kinki University School of Medicine
city: Ogikubo
country: Japan
facility: Ogikubo Hospital
city: Saiseikai NOE
country: Japan
facility: Saiseikai Noe Hospital
city: Tokai
country: Japan
facility: Tokai University School of Medicine
city: Tokio
country: Japan
facility: Tokio Metropolitan Geriatric Hospital
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Carnaxide
country: Portugal
facility: Hospital de Santa Cruz
state: Lisboa
city: Almada
country: Portugal
facility: Hospital Garcia Orta
city: Faro
country: Portugal
facility: Hospital Central Faro
city: Lisboa
country: Portugal
facility: Hospital Egas Moniz
city: Lisboa
country: Portugal
facility: Hospital Santa Maria
city: Lisboa
country: Portugal
facility: Hospital Santa Marta
city: Lisboa
country: Portugal
facility: Hospital São Francisco Xavier
city: Santarem
country: Portugal
facility: Hospital Distrital de Santarém
city: Denia
country: Spain
facility: Hospital Marina Alta
city: Elda
country: Spain
facility: Hospital General de Elda
city: Gijon
country: Spain
facility: Hospital de Cabuenes
city: Orihuela
country: Spain
facility: Hospital Vega Baja
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valencia
country: Spain
facility: Hospital La Fe
city: Vigo
country: Spain
facility: Meixoeiro
Study officials:
affiliation: CHU la Timone - Marseille
name: DEHARO Jean Claude, MD
role: PRINCIPAL_INVESTIGATOR
References: