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

Completed

• Conditions: Atrioventricular Block; Sinus 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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2015-10-23
• Study First Posted: 2015-10-26
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 848

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

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

Trial Locations

Locations (58)

CH Basse Terre; 🇫🇷 Terre Basse, Guadeloupe, France

CH du Pays d'Aix; 🇫🇷 Aix-en-Provence, France

CH Alençon; 🇫🇷 Alençon, France

Cabinet Alès; 🇫🇷 Alès, France

hôpital Sud; 🇫🇷 Amiens, France

CH Annecy; 🇫🇷 Annecy, France

hôpital privé Antony; 🇫🇷 Antony, France

hôpital d'Argenteuil; 🇫🇷 Argenteuil, France

hôpital St André; 🇫🇷 Bordeaux, France

CH Bourges; 🇫🇷 Bourges, France

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