Clinical trial NCT02586480: Evolution of the PR Interval in Patients Implanted With a Pacemaker Using the SafeR Mode
Official title: Evolution of the PR Interval in Patients Implanted With a Dual Chamber Pacemaker With Algorithm for Spontaneous AV Conduction Preservation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sinus Node Dysfunction
Atrioventricular Block
Keywords: bradycardia
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2015-10-26
Enrollment: 848
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bradycardia patients eligible for dual chamber pacemaker implantation for SND, AVBI or AVBII

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prolonged PR interval (> 200ms) in patients without AVB I at baseline (Incidence of "clinical" AVB1)
timeFrame: at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Terre Basse
country: France
facility: CH Basse Terre
state: Guadeloupe
city: Aix-en-Provence
country: France
facility: CH du Pays d'Aix
city: Alençon
country: France
facility: CH Alençon
city: Alès
country: France
facility: Cabinet Alès
city: Amiens
country: France
facility: hôpital Sud
city: Annecy
country: France
facility: CH Annecy
city: Antony
country: France
facility: hôpital privé Antony
city: Argenteuil
country: France
facility: hôpital d'Argenteuil
city: Bordeaux
country: France
facility: hôpital St André
city: Bourges
country: France
facility: CH Bourges
city: Brest
country: France
facility: CHU Brest
city: Brest
country: France
facility: Clinique Keraudren
city: Caen
country: France
facility: CHU Caen
city: Calais
country: France
facility: Clinique des 2 Caps
city: Chartres
country: France
facility: CH Chartres
city: Chaumont
country: France
facility: Ch Chaumont
city: Cherbourg
country: France
facility: Cabinet Cherbourg
city: Clamart
country: France
facility: HIA Percy
city: Colmar
country: France
facility: Hôpital L. Pasteur
city: Corbeil Essonnes
country: France
facility: CH Corbeil Essonnes
city: Creutzwald
country: France
facility: Cabinet Creutzwald
city: Créteil
country: France
facility: Hopital Henri Mondor
city: Dinan
country: France
facility: CH Dinan
city: Douarnenez
country: France
facility: CH Douarnenez
city: Evreux
country: France
facility: CH Evreux
city: Evry
country: France
facility: CMCO Evry
city: Forbach
country: France
facility: Cabinet Forbach
city: Forbach
country: France
facility: CH Forbach
city: Haguenau
country: France
facility: CH Haguenau
city: Helfaut
country: France
facility: CH Helfaut
city: Lannion
country: France
facility: CH Lannion
city: Le Havre
country: France
facility: CH Le Havre
city: Le Mans
country: France
facility: CMCM Le Mans
city: Le Port-Marly
country: France
facility: CMC Port Marly
city: Lomme
country: France
facility: CH Lomme
city: Lorient
country: France
facility: CH Lorient
city: Marseille
country: France
facility: CHU La Timone
city: Marseille
country: France
facility: Hôpital Nord
city: Melun
country: France
facility: Clinique Melun
city: Metz
country: France
facility: CH Privé Metz
city: Montfermeil
country: France
facility: CH Montfermeil
city: Montpellier
country: France
facility: Clinique Montpellier
city: Nancy
country: France
facility: Clinique A. Paré
city: Nantes
country: France
facility: NCN Nantes
city: Orléans
country: France
facility: CH Orléans
city: Paris
country: France
facility: Cabinet Paris
city: Paris
country: France
facility: CH St Joseph
city: Poissy
country: France
facility: CH Poissy St Germain
city: Poitiers
country: France
facility: CHU Poitiers
city: Rouen
country: France
facility: Clinique St Hilaire
city: Saint Denis
country: France
facility: CCN St Denis
city: Saint Nazaire
country: France
facility: CH St Nazaire
city: Sens
country: France
facility: CH Sens
city: St Malo
country: France
facility: CH St Malo
city: Thionville
country: France
facility: CH Thionville
city: Valenciennes
country: France
facility: CH Valenciennes
city: Valognes
country: France
facility: Cabinet Valognes
city: Villefranche Sur Saone
country: France
facility: CH Villefrance
Study officials:
affiliation: CH du Pays d'Aix - Aix en Provence
name: Jérôme TAIEB, MD
role: PRINCIPAL_INVESTIGATOR
References: