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

NCT02586480 — Completed, 848 participants, LivaNova

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Evolution of the PR Interval in Patients Implanted With a Dual Chamber Pacemaker With Algorithm for Spontaneous AV Conduction Preservation

RegistryNCT02586480, acronym PRECISE
StatusCompleted
Study typeObservational
Enrollment848 (Actual)
SponsorLivaNova (Industry)
ConditionsSinus Node Dysfunction, Atrioventricular Block
Interventionsdual chamber pacemaker with SafeR algorithm (Device)
Datesstart 2012-04-01, primary completion 2015-11-01, completion 2015-12-01, first posted 2015-10-26, last updated 2017-10-18
Locations58 sites in France

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-Summary

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

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+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.

+Arms and interventions

  • dual chamber pacemaker with SafeR algorithm (Device), also known as Reply DR (Sorin Devices): 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.

+Outcome measures

Primary outcomes

  • 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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (58)

FacilityCityCountryStatus
CH Basse TerreTerre Basse, GuadeloupeFrance
CH du Pays d'AixAix-en-ProvenceFrance
CH AlençonAlençonFrance
Cabinet AlèsAlèsFrance
hôpital SudAmiensFrance
CH AnnecyAnnecyFrance
hôpital privé AntonyAntonyFrance
hôpital d'ArgenteuilArgenteuilFrance
hôpital St AndréBordeauxFrance
CH BourgesBourgesFrance
CHU BrestBrestFrance
Clinique KeraudrenBrestFrance
CHU CaenCaenFrance
Clinique des 2 CapsCalaisFrance
CH ChartresChartresFrance
Ch ChaumontChaumontFrance
Cabinet CherbourgCherbourgFrance
HIA PercyClamartFrance
Hôpital L. PasteurColmarFrance
CH Corbeil EssonnesCorbeil-EssonnesFrance
Cabinet CreutzwaldCreutzwaldFrance
Hopital Henri MondorCréteilFrance
CH DinanDinanFrance
CH DouarnenezDouarnenezFrance
CH EvreuxÉvreuxFrance
CMCO EvryÉvryFrance
Cabinet ForbachForbachFrance
CH ForbachForbachFrance
CH HaguenauHaguenauFrance
CH HelfautHelfautFrance
CH LannionLannionFrance
CH Le HavreLe HavreFrance
CMCM Le MansLe MansFrance
CMC Port MarlyLe Port-MarlyFrance
CH LommeLommeFrance
CH LorientLorientFrance
CHU La TimoneMarseilleFrance
Hôpital NordMarseilleFrance
Clinique MelunMelunFrance
CH Privé MetzMetzFrance
CH MontfermeilMontfermeilFrance
Clinique MontpellierMontpellierFrance
Clinique A. ParéNancyFrance
NCN NantesNantesFrance
CH OrléansOrléansFrance
Cabinet ParisParisFrance
CH St JosephParisFrance
CH Poissy St GermainPoissyFrance
CHU PoitiersPoitiersFrance
Clinique St HilaireRouenFrance
CCN St DenisSaint-DenisFrance
CH St NazaireSaint-NazaireFrance
CH SensSensFrance
CH St MaloSt-MaloFrance
CH ThionvilleThionvilleFrance
CH ValenciennesValenciennesFrance
Cabinet ValognesValognesFrance
CH VillefranceVillefranche-sur-SaôneFrance

+Investigators

  • Jérôme TAIEB, MD, Principal investigator, CH du Pays d'Aix - Aix en Provence

My Notes