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

NCT02586480 | Completed

• 1 other identifier: RBSY02
• Study Type: observational
• Target: 848
• Locations: 1 country
• Sites: 58

Brief Summary

Observational study on long PR interval using the SafeR mode in bradycardia patients.

Conditions

Sinus Node Dysfunction; Atrioventricular Block

Keywords

bradycardia

Outcome Measures

Primary Outcomes (1)

• Prolonged PR interval (> 200ms) in patients without AVB I at baseline (Incidence of "clinical" AVB1)

  This incidence will be measured using PR/AR histograms stored in the device memory

  at 12 months

Interventions

dual chamber pacemaker with SafeR algorithm DEVICE

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.

Also known as: Reply DR (Sorin Devices)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Bradycardia patients eligible for dual chamber pacemaker implantation for SND, AVBI or AVBII

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LivaNova: lead

Study Sites (58)

CH Basse Terre

Terre Basse, Guadeloupe, France

Location

CH du Pays d'Aix

Aix-en-Provence, France

Location

CH Alençon

Alençon, France

Location

Cabinet Alès

Alès, France

Location

hôpital Sud

Amiens, France

Location

CH Annecy

Annecy, France

Location

hôpital privé Antony

Antony, France

Location

hôpital d'Argenteuil

Argenteuil, France

Location

hôpital St André

Bordeaux, France

Location

CH Bourges

Bourges, France

Location

CHU Brest

Brest, France

Location

Clinique Keraudren

Brest, France

Location

CHU Caen

Caen, France

Location

Clinique des 2 Caps

Calais, France

Location

CH Chartres

Chartres, France

Location

Ch Chaumont

Chaumont, France

Location

Cabinet Cherbourg

Cherbourg, France

Location

HIA Percy

Clamart, France

Location

Hôpital L. Pasteur

Colmar, France

Location

CH Corbeil Essonnes

Corbeil-Essonnes, France

Location

Cabinet Creutzwald

Creutzwald, France

Location

Hopital Henri Mondor

Créteil, France

Location

CH Dinan

Dinan, France

Location

CH Douarnenez

Douarnenez, France

Location

CH Evreux

Évreux, France

Location

CMCO Evry

Évry, France

Location

Cabinet Forbach

Forbach, France

Location

CH Forbach

Forbach, France

Location

CH Haguenau

Haguenau, France

Location

CH Helfaut

Helfaut, France

Location

CH Lannion

Lannion, France

Location

CH Le Havre

Le Havre, France

Location

CMCM Le Mans

Le Mans, France

Location

CMC Port Marly

Le Port-Marly, France

Location

CH Lomme

Lomme, France

Location

CH Lorient

Lorient, France

Location

CHU La Timone

Marseille, France

Location

Hôpital Nord

Marseille, France

Location

Clinique Melun

Melun, France

Location

CH Privé Metz

Metz, France

Location

CH Montfermeil

Montfermeil, France

Location

Clinique Montpellier

Montpellier, France

Location

Clinique A. Paré

Nancy, France

Location

NCN Nantes

Nantes, France

Location

CH Orléans

Orléans, France

Location

Cabinet Paris

Paris, France

Location

CH St Joseph

Paris, France

Location

CH Poissy St Germain

Poissy, France

Location

CHU Poitiers

Poitiers, France

Location

Clinique St Hilaire

Rouen, France

Location

CCN St Denis

Saint-Denis, France

Location

CH St Nazaire

Saint-Nazaire, France

Location

CH Sens

Sens, France

Location

CH St Malo

St-Malo, France

Location

CH Thionville

Thionville, France

Location

CH Valenciennes

Valenciennes, France

Location

Cabinet Valognes

Valognes, France

Location

CH Villefrance

Villefranche-sur-Saône, France

Location

MeSH Terms

Conditions

Sick Sinus Syndrome; Atrioventricular Block; Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jérôme TAIEB, MD

  CH du Pays d'Aix - Aix en Provence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 26, 2015
• Study Start: April 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 18, 2017

Record last verified: 2017-10

Locations

FR (58)