Evolution of the PR Interval in Patients Implanted With a Pacemaker Using the SafeR Mode
- Conditions
- Atrioventricular BlockSinus Node Dysfunction
- Registration Number
- NCT02586480
- Lead Sponsor
- LivaNova
- Brief Summary
Observational study on long PR interval using the SafeR mode in bradycardia patients.
- Detailed Description
This observational trial aims to study the evolution of the PR interval in patients implanted with a dual chamber pacemaker with the SafeR mode. The investigators will assess the prevalence and the incidence of PR lengthening and the investigators will study the long PR interval management by physicians, depending on the data embedded in the pacemaker.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 848
- Patient implanted (primo-implant, replacement, upgrade) with a Sorin Group™ dual chamber pacemaker according to current available guidelines and IFU from less than three months.
- Since implantation, the device is programmed in SafeR mode
- Patient agreed to participate, after having received the appropriate and mandatory information
- Patient contraindicated for cardiac pacing, according to current available guidelines
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prolonged PR interval (> 200ms) in patients without AVB I at baseline (Incidence of "clinical" AVB1) at 12 months This incidence will be measured using PR/AR histograms stored in the device memory
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (58)
CH Sens
🇫🇷Sens, France
CH du Pays d'Aix
🇫🇷Aix-en-Provence, France
CH Alençon
🇫🇷Alençon, France
hôpital Sud
🇫🇷Amiens, France
Cabinet Alès
🇫🇷Alès, France
CH Annecy
🇫🇷Annecy, France
Clinique Keraudren
🇫🇷Brest, France
hôpital privé Antony
🇫🇷Antony, France
CHU Caen
🇫🇷Caen, France
hôpital d'Argenteuil
🇫🇷Argenteuil, France
CHU Brest
🇫🇷Brest, France
hôpital St André
🇫🇷Bordeaux, France
CH Bourges
🇫🇷Bourges, France
CH Chartres
🇫🇷Chartres, France
Clinique des 2 Caps
🇫🇷Calais, France
Cabinet Cherbourg
🇫🇷Cherbourg, France
Ch Chaumont
🇫🇷Chaumont, 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 Douarnenez
🇫🇷Douarnenez, France
CH Dinan
🇫🇷Dinan, France
CH Evreux
🇫🇷Evreux, France
CMCO Evry
🇫🇷Evry, France
Cabinet Forbach
🇫🇷Forbach, France
CH Haguenau
🇫🇷Haguenau, France
CH Forbach
🇫🇷Forbach, France
CH Helfaut
🇫🇷Helfaut, France
CMC Port Marly
🇫🇷Le Port-Marly, France
CH Lannion
🇫🇷Lannion, France
CMCM Le Mans
🇫🇷Le Mans, France
CH Le Havre
🇫🇷Le Havre, France
CH Lorient
🇫🇷Lorient, France
CH Lomme
🇫🇷Lomme, France
CHU La Timone
🇫🇷Marseille, France
CH Montfermeil
🇫🇷Montfermeil, France
Clinique Melun
🇫🇷Melun, France
Hôpital Nord
🇫🇷Marseille, France
CH Privé Metz
🇫🇷Metz, France
Clinique Montpellier
🇫🇷Montpellier, France
Clinique A. Paré
🇫🇷Nancy, France
NCN Nantes
🇫🇷Nantes, France
Cabinet Paris
🇫🇷Paris, France
CH Orléans
🇫🇷Orléans, 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 St Malo
🇫🇷St Malo, France
CH Thionville
🇫🇷Thionville, France
Cabinet Valognes
🇫🇷Valognes, France
CH Villefrance
🇫🇷Villefranche Sur Saone, France
CH Basse Terre
🇫🇷Terre Basse, Guadeloupe, France
CH Valenciennes
🇫🇷Valenciennes, France