Evolution of the PR Interval in Patients Implanted With a Pacemaker Using the SafeR Mode
NCT ID: NCT02586480
Last Updated: 2017-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
848 participants
OBSERVATIONAL
2012-04-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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dual chamber pacemaker with SafeR algorithm
SafeR is an AVB management algorithm: it provides AAI pacing while continuously monitoring AV conduction, it switches to DDD when detecting AVB I, II or III, according to the following criteria: (1) AVB I: 6 long PR intervals, (2) AVB II: 3 blocked atrial events/12 cycles, (3) AVB III: 2 consecutive blocked atrial events. It switches back to AAI mode when needed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Since implantation, the device is programmed in SafeR mode
* Patient agreed to participate, after having received the appropriate and mandatory information
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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LivaNova
INDUSTRY
Responsible Party
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Principal Investigators
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Jérôme TAIEB, MD
Role: PRINCIPAL_INVESTIGATOR
CH du Pays d'Aix - Aix en Provence
Locations
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CH Basse Terre
Terre Basse, Guadeloupe, France
CH du Pays d'Aix
Aix-en-Provence, , France
CH Alençon
Alençon, , France
Cabinet Alès
Alès, , France
hôpital Sud
Amiens, , France
CH Annecy
Annecy, , France
hôpital privé Antony
Antony, , France
hôpital d'Argenteuil
Argenteuil, , France
hôpital St André
Bordeaux, , France
CH Bourges
Bourges, , France
CHU Brest
Brest, , France
Clinique Keraudren
Brest, , France
CHU Caen
Caen, , France
Clinique des 2 Caps
Calais, , France
CH Chartres
Chartres, , France
Ch Chaumont
Chaumont, , France
Cabinet Cherbourg
Cherbourg, , France
HIA Percy
Clamart, , France
Hôpital L. Pasteur
Colmar, , France
CH Corbeil Essonnes
Corbeil-Essonnes, , France
Cabinet Creutzwald
Creutzwald, , France
Hopital Henri Mondor
Créteil, , France
CH Dinan
Dinan, , France
CH Douarnenez
Douarnenez, , France
CH Evreux
Évreux, , France
CMCO Evry
Évry, , France
Cabinet Forbach
Forbach, , France
CH Forbach
Forbach, , France
CH Haguenau
Haguenau, , France
CH Helfaut
Helfaut, , France
CH Lannion
Lannion, , France
CH Le Havre
Le Havre, , France
CMCM Le Mans
Le Mans, , France
CMC Port Marly
Le Port-Marly, , France
CH Lomme
Lomme, , France
CH Lorient
Lorient, , France
CHU La Timone
Marseille, , France
Hôpital Nord
Marseille, , France
Clinique Melun
Melun, , France
CH Privé Metz
Metz, , France
CH Montfermeil
Montfermeil, , France
Clinique Montpellier
Montpellier, , France
Clinique A. Paré
Nancy, , France
NCN Nantes
Nantes, , France
CH Orléans
Orléans, , France
Cabinet Paris
Paris, , France
CH St Joseph
Paris, , France
CH Poissy St Germain
Poissy, , France
CHU Poitiers
Poitiers, , France
Clinique St Hilaire
Rouen, , France
CCN St Denis
Saint-Denis, , France
CH St Nazaire
Saint-Nazaire, , France
CH Sens
Sens, , France
CH St Malo
St-Malo, , France
CH Thionville
Thionville, , France
CH Valenciennes
Valenciennes, , France
Cabinet Valognes
Valognes, , France
CH Villefrance
Villefranche-sur-Saône, , France
Countries
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Other Identifiers
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RBSY02
Identifier Type: -
Identifier Source: org_study_id