Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers (NATURE)
November 10, 2017 updated by: LivaNova
Observational study to assess AV block incidence and their evolution according to paroxysmal atrial arrhythmia.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1440
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
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Dendermonde, Belgium
- Az St- Blasius
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HUY, Belgium
- Ch de Huy
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MOL, Belgium
- Heilig Hart Ziekenhuis MOL
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Hamilton, Canada
- Hospital Hamilton
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Niagara, Canada
- Niagara Health System
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Bispebjerg, Denmark
- Bispebjerg hospital
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Gentofte Hospital, Denmark
- HELLERUP
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Agen, France
- Clinique Esquirol
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Albi, France
- CH Albi
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Albi, France
- Clinique Claude Bernard
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Ales, France
- CH ALES
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Ales, France
- Clinique Bonnefond
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Annecy, France
- Cabinet privé
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Aressy, France
- Clinique Aressy
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Auch, France
- CH Auch
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Bayonne, France
- Clinique Paulmy
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Beauvais, France
- CH Beauvais
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Besancon, France
- Clinique St Vincent
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Beziers, France
- CH Béziers
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Biarritz, France
- Clinique Aguilera
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Bordeaux, France
- Chu Pessac
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Bordeaux, France
- Clinique Des Pins Francs
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Boulogne Sur Mer, France
- CH Boulogne
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Brest, France
- CHU Brest
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Brive, France
- CH Brive
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Calais, France
- Clinique Des 2 Caps
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Calais, France
- CH Calais
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Carcassonne, France
- CH Carcassonne
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Ceret, France
- Chu Ceret
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Chalons En Champagne, France
- Ch Chalons
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Chatellerault, France
- Clinique Bon Secours
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Chaumont, France
- Ch Chaumont
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Cherbourg, France
- CH Cherbourg
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Colmar, France
- CH Colmar
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Creutzwald, France
- Cabinet Cardiologie Creutzwald
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Croix, France
- Polyclinique du Parc
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Dinan, France
- CH DINAN
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Dole, France
- CH DOLE
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Douai, France
- CH DOUAI
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Douarnenez, France
- Ch Douarnenez
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Draguignan, France
- Polyclinique Notre Dame
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Eaubonne, France
- Hôpital Emile Roux
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Evecquemont, France
- Centre Cardiologique d'Evecquemont
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Evreux, France
- Hôpital D'Evreux
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Firminy, France
- Ch Firminy
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Forbach, France
- Ch Forbach
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Freyming Merlebach, France
- Ch Freyming
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GAP, France
- CH Gap
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Lannion, France
- Ch Lannion
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Le Chesnay, France
- CMC Parly II
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Le Havre, France
- CH Le Havre
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Le Havre, France
- CHU Le Havre
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Lyon, France
- Hôpital Cardiologique
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Marseille, France
- CHU La Timone
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Marseille, France
- Hôpital Nord
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Martigues, France
- Chg Martigues
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Massy, France
- Institut Hospitalier Jacques Cartier
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Metz, France
- Hôpital Ste Blandine
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Montauban, France
- Clinique Pont Chaume
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Montfermeil, France
- Hôpital Le Raincy Monfermeil
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Montpellier, France
- CHU Montpellier
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Mougins, France
- Clinique Plein Ciel
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Moulins, France
- Ch Moulins
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Mulhouse, France
- Clinique Du Diaconnat
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Neuilly Sur Seine, France
- Centre Chirurgical Ambroise Paré
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Nevers, France
- CH Nevers
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Ollioules, France
- Clinique des Fleurs
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Orange, France
- Ch Orange
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PAU, France
- CHU PAU
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PORT Marly, France
- Centre Medico Chirurgical de L'Europe
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Paris, France
- Clinique BIZET
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Paris, France
- Clinique Parc Monceau
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Paris, France
- Hopital Val de GRACE
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Perpignan, France
- CH Perpignan
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Poitiers, France
- CHU Poitiers
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Quincy Sous Senart, France
- Hôpital Privé Claude Galien
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Ris Orangis, France
- Clinique Pasteur
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Rodez, France
- CH Rodez
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Rouen, France
- Clinique St Hilaire Rouen
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STE Feyre, France
- Cmc Ste Feyre
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Saint André Les Vergers, France
- Polyclinique de Montier La Celle
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Saint Die Des Vosges, France
- Clinique Notre Dame
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Sarcelles, France
- Hôpital Prive Nord Parisien
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St Denis, France
- Centre Cardiologique du Nord
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St Malo, France
- CH St Malo
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Tours, France
- Clinique St Gatien
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Valenciennes, France
- Clinique Vauban
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Annaberg, Germany
- Erzgebirgsklinikum ANNABERG
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Berlin, Germany
- Schade Stolz Rötech
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Bogenhausen, Germany
- Klinikum Bogenhausen
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Dresden, Germany
- Klinikum Dresden
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Hamburg, Germany
- PRAXIS Dr Subin und Lutter
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Montebelluna, Italy
- Hospital Montebelluna
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Negrar, Italy
- Hospital Negrar
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Peschiera del Garda, Italy
- Casa di cura Pederzoli
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Kanagawa, Japan
- Kanagawa Cardiov. and Respiratory Center
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Kokura, Japan
- Kokura Memorial Hospital
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Konan, Japan
- Konan St Hill Hospital
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Kyosai, Japan
- Yokosuka Kyosai General Hospital
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MIE, Japan
- Mie University Hospital
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Nara, Japan
- Nara Hospital, Kinki University School of Medicine
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Ogikubo, Japan
- Ogikubo Hospital
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Saiseikai NOE, Japan
- Saiseikai Noe Hospital
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Tokai, Japan
- Tokai University School of Medicine
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Tokio, Japan
- Tokio Metropolitan Geriatric Hospital
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Yokohama, Japan
- Yokohama City University Hospital
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Seoul, Korea, Republic of
- Seoul National University Hospital
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Almada, Portugal
- Hospital Garcia Orta
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Faro, Portugal
- Hospital Central Faro
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Lisboa, Portugal
- Hospital Santa Maria
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Lisboa, Portugal
- Hospital Santa Marta
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Lisboa, Portugal
- Hospital Egas Moniz
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Lisboa, Portugal
- Hospital São Francisco Xavier
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Santarem, Portugal
- Hospital Distrital de Santarém
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Lisboa
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Carnaxide, Lisboa, Portugal
- Hospital de Santa Cruz
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Denia, Spain
- Hospital Marina Alta
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Elda, Spain
- Hospital General de Elda
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Gijon, Spain
- Hospital de Cabueñes
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Orihuela, Spain
- Hospital Vega Baja
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Valencia, Spain
- Hospital Arnau de Vilanova
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Valencia, Spain
- Hospital La Fe
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Vigo, Spain
- Meixoeiro
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Alabama
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Birmingham, Alabama, United States
- Baptist Princeton Birmingham
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Sheffield, Alabama, United States
- Tennessee Valley Sheffield
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Arizona
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Mesa, Arizona, United States
- Cardiovascular Assoc. Of Mesa
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California
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San Jose, California, United States
- O'Connor Hospital San Jose
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Georgia
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Piedmont, Georgia, United States
- Piedmont Hospital
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Mississippi
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Mississippi, Mississippi, United States
- University of Mississippi Medical Center
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Oklahoma
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Tulsa, Oklahoma, United States
- St. Francis Hospital Tulsa
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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
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.
Description
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
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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High degree AV blocks
Time Frame: 2 years
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: DEHARO Jean Claude, MD, CHU la Timone - Marseille
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
June 1, 2007
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
September 17, 2007
First Submitted That Met QC Criteria
September 17, 2007
First Posted (Estimate)
September 18, 2007
Study Record Updates
Last Update Posted (Actual)
November 14, 2017
Last Update Submitted That Met QC Criteria
November 10, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nature - RGST01
- RGST01
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.