Evolution of the PR Interval in Patient… | Clinical Trial

Key information

Conditions

Sinus Node Dysfunction Arrhythmia, Sinus Arrhythmias, Cardiac Atrioventricular Block Bradycardia Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sick Sinus Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Basse Terre, Terre Basse, Guadeloupe, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Reply DR (Sorin Devices)

Primary outcomes

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

Time frame: at 12 months

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

Sponsors and collaborators

Lead sponsor

LivaNova

Industry

Registry information

Official study title

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

Acronym: PRECISE

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Oct 26, 2015
Registry last updated: Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed