Patients Implanted With a PacemakerNATURENCT00531037
Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers
An observational study of Patients Implanted With a Pacemaker, run by LivaNova at 129 sites in 11 countries.
Trial summary
Observational study to assess AV block incidence and their evolution according to paroxysmal atrial arrhythmia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Implanted With a Pacemaker
- How many people
- 1,440 participants
- Where
- 129 sitesin 11 countries
- Study dates
- Jun 2007to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Sinus Node Disease
- Brady-Tachy Syndrome
- Suspected or documented paroxysmal AVB
Who cannot join
- Permanent high degree AVB
- Contra indication to the SafeR pacing mode
- PR higher than 350 ms
Trial locations and contacts
129 sites in 11 countries.
129 sites in 11 countries
France80 sites
Clinique Esquirol
Agen
CH Albi
Albi
Clinique Claude Bernard
Albi
CH ALES
Alès
Clinique Bonnefond
Alès
Cabinet Prive
Annecy
Clinique Aressy
Aressy
CH AUCH
Auch
Clinique Paulmy
Bayonne
Ch Beauvais
Beauvais
Clinique St Vincent
Besançon
Ch Beziers
Béziers
Clinique Aguilera
Biarritz
Chu Pessac
Bordeaux
Clinique Des Pins Francs
Bordeaux
Ch Boulogne
Boulogne-sur-Mer
Chu Brest
Brest
CH BRIVE
Brivé
Ch Calais
Calais
Clinique Des 2 Caps
Calais
Ch Carcassonne
Carcassonne
Chu Ceret
Ceret
Ch Chalons
Châlons-en-Champagne
Clinique Bon Secours
Châtellerault
Ch Chaumont
Chaumont
Ch Cherbourg
Cherbourg
Ch Colmar
Colmar
Cabinet Cardiologie Creutzwald
Creutzwald
Polyclinique Du Parc
Croix
CH DINAN
Dinan
CH DOLE
Dole
CH DOUAI
Douai
Ch Douarnenez
Douarnenez
Polyclinique Notre Dame
Draguignan
Hôpital Emile Roux
Eaubonne
Centre Cardiologique D'Evecquemont
Évecquemont
Hôpital D'Evreux
Évreux
Ch Firminy
Firminy
Ch Forbach
Forbach
Ch Freyming
Freyming-Merlebach
CH GAP
Gap
Ch Lannion
Lannion
Cmc Parly Ii
Le Chesnay
Ch Le Havre
Le Havre
Chu Le Havre
Le Havre
Centre Medico Chirurgical de L'Europe
Le Port-Marly
Hôpital Cardiologique
Lyon
Chu La Timone
Marseille
Hôpital Nord
Marseille
Chg Martigues
Martigues
Institut Hospitalier Jacques Cartier
Massy
Hôpital Ste Blandine
Metz
Clinique Pont Chaume
Montauban
Hôpital Le Raincy Monfermeil
Montfermeil
Chu Montpellier
Montpellier
Clinique Plein Ciel
Mougins
Ch Moulins
Moulins
Clinique Du Diaconnat
Mulhouse
Centre Chirurgical Ambroise Pare
Neuilly-sur-Seine
Ch Nevers
Nevers
Clinique Des Fleurs
Ollioules
Ch Orange
Orange
Clinique Bizet
Paris
Clinique Parc Monceau
Paris
Hôpital Val de Grâce
Paris
CHU PAU
Pau
Ch Perpignan
Perpignan
Chu Poitiers
Poitiers
Hôpital Prive Claude Galien
Quincy-sous-Sénart
Clinique Pasteur
Ris-Orangis
CH RODEZ
Rodez
Clinique St Hilaire Rouen
Rouen
Polyclinique de Montier La Celle
Saint-André-les-Vergers
Centre Cardiologique Du Nord
Saint-Denis
Clinique Notre Dame
Saint-Dié
Hôpital Prive Nord Parisien
Sarcelles
Ch St Malo
St-Malo
Cmc Ste Feyre
STE Feyre
Clinique St Gatien
Tours
Clinique Vauban
Valenciennes
Japan11 sites
Kanagawa Cardiov. and Respiratory Center
Kanagawa
Kokura Memorial Hospital
Kokura
Konan St Hill Hospital
Kōnan
Yokosuka Kyosai General Hospital
Kyosai
Mie University Hospital
Mie
Nara Hospital, Kinki University School of Medicine
Nara
Ogikubo Hospital
Ogikubo
Saiseikai Noe Hospital
Saiseikai NOE
Tokai University School of Medicine
Tōkai
Tokio Metropolitan Geriatric Hospital
Tokyo
Yokohama City University Hospital
Yokohama
Portugal8 sites
Hospital Garcia Orta
Almada
Hospital de Santa Cruz
Carnaxide, Lisbon District
Hospital Central Faro
Faro
Hospital Egas Moniz
Lisbon
Hospital Santa Maria
Lisbon
Hospital Santa Marta
Lisbon
Hospital São Francisco Xavier
Lisbon
Hospital Distrital de Santarém
Santarém
United States7 sites
Baptist Princeton Birmingham
Birmingham, Alabama
Cardiovascular Assoc. Of Mesa
Mesa, Arizona
University of Mississippi Medical Center
Mississippi City, Mississippi
Piedmont hospital
Piedmont, Georgia
O'Connor Hospital San Jose
San Jose, California
Tennessee Valley Sheffield
Sheffield, Alabama
St. Francis Hospital Tulsa
Tulsa, Oklahoma
Spain7 sites
Hospital Marina Alta
Denia
Hospital General de Elda
Elda
Hospital de Cabuenes
Gijón
Hospital Vega Baja
Orihuela
Hospital Arnau de Vilanova
Valencia
Hospital La Fe
Valencia
Meixoeiro
Vigo
Germany5 sites
Erzgebirgsklinikum ANNABERG
Annaberg
Schade Stolz Rötech
Berlin
Klinikum Bogenhausen
Bogenhausen
Klinikum Dresden
Dresden
PRAXIS Dr Subin und Lutter
Hamburg
Belgium3 sites
Az St- Blasius
Dendermonde
Ch de Huy
Huy
Heilig Hart Ziekenhuis MOL
Mol
Italy3 sites
Hospital Montebelluna
Montebelluna
Hospital Negrar
Negrar
Casa di Cura Pederzoli
Peschiera del Garda
About this study
Observational study to assess AV block incidence and their evolution according to paroxysmal atrial arrhythmia.
- Conditions
- Patients Implanted With a Pacemaker
- Keywords
- AV block, SND, BTS, AAIsafeR, SafeR, PM implanted
- Medical subject headings
- Atrioventricular Block, Neuronal Ceroid-Lipofuscinoses
What is being measured
The primary outcome is the main question the study is designed to answer.
High degree AV blocks
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Implanted With a PacemakerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,440 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- DEHARO Jean Claude, MD, Principal investigator, CHU la Timone - Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531037
- Sponsor's protocol ID
- Nature - RGST01
- Other IDs
- RGST01
- Acronym
- NATURE
- Status last verified
- Nov 2017
- First submitted
- 17 Sep 2007
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers
- ClinicalTrials.gov ID
- NCT00531037
- Acronym / sponsor ID
- NATURE / Nature - RGST01
- Conditions
- Patients Implanted With a Pacemaker
- Keywords
- AV block, SND, BTS, AAIsafeR, SafeR, PM implanted
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,440 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 18 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational study to assess AV block incidence and their evolution according to paroxysmal atrial arrhythmia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Sinus Node Disease
- Brady-Tachy Syndrome
- Suspected or documented paroxysmal AVB
Key exclusion criteria (3 listed)
- Permanent high degree AVB
- Contra indication to the SafeR pacing mode
- PR higher than 350 ms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
High degree AV blocks
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
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RecruitingObservational study
One Year Pacing Dependency After TAVR
Patients Above 18 Years, Patient Discharge
RecruitingObservational study
Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.
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Recruiting
Comparison of the Efficacy and Safety of Cardioneuroablation to Permanent Pacing in Patients With an Implanted Pacemaker for Symptomatic Bradycardia.
Bradycardia, Syncope
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DEHARO Jean Claude, MD principal investigator
CHU la Timone - Marseille
129 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Implanted With a Pacemaker, run by LivaNova at 129 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 129 sites in France, Japan, Portugal, United States, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High degree AV blocks (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.