Evolution of the PR Interval in Patients Implanted With a Pacemaker Using the SafeR Mode

CompletedOBSERVATIONAL
Enrollment

848

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

November 30, 2015

Study Completion Date

December 31, 2015

Conditions
Sinus Node DysfunctionAtrioventricular Block
Interventions
DEVICE

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.

Trial Locations (58)

Unknown

CH Basse Terre, Terre Basse

CH du Pays d'Aix, Aix-en-Provence

CH Alençon, Alençon

Cabinet Alès, Alès

hôpital Sud, Amiens

CH Annecy, Annecy

hôpital privé Antony, Antony

hôpital d'Argenteuil, Argenteuil

hôpital St André, Bordeaux

CH Bourges, Bourges

CHU Brest, Brest

Clinique Keraudren, Brest

CHU Caen, Caen

Clinique des 2 Caps, Calais

CH Chartres, Chartres

Ch Chaumont, Chaumont

Cabinet Cherbourg, Cherbourg

HIA Percy, Clamart

Hôpital L. Pasteur, Colmar

CH Corbeil Essonnes, Corbeil-Essonnes

Cabinet Creutzwald, Creutzwald

Hopital Henri Mondor, Créteil

CH Dinan, Dinan

CH Douarnenez, Douarnenez

CH Evreux, Évreux

CMCO Evry, Évry

Cabinet Forbach, Forbach

CH Forbach, Forbach

CH Haguenau, Haguenau

CH Helfaut, Helfaut

CH Lannion, Lannion

CH Le Havre, Le Havre

CMCM Le Mans, Le Mans

CMC Port Marly, Le Port-Marly

CH Lomme, Lomme

CH Lorient, Lorient

CHU La Timone, Marseille

Hôpital Nord, Marseille

Clinique Melun, Melun

CH Privé Metz, Metz

CH Montfermeil, Montfermeil

Clinique Montpellier, Montpellier

Clinique A. Paré, Nancy

NCN Nantes, Nantes

CH Orléans, Orléans

Cabinet Paris, Paris

CH St Joseph, Paris

CH Poissy St Germain, Poissy

CHU Poitiers, Poitiers

Clinique St Hilaire, Rouen

CCN St Denis, Saint-Denis

CH St Nazaire, Saint-Nazaire

CH Sens, Sens

CH St Malo, St-Malo

CH Thionville, Thionville

CH Valenciennes, Valenciennes

Cabinet Valognes, Valognes

CH Villefrance, Villefranche-sur-Saône

Sponsors

Lead Sponsor

All Listed Sponsors
lead

LivaNova

INDUSTRY