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

LivaNova

Status: Completed

Conditions: Atrioventricular Block; Sinus Node Dysfunction

Treatments: Device: dual chamber pacemaker with SafeR algorithm

Study type: Observational

Funder types: Industry

Identifiers

NCT02586480

RBSY02

Details and patient eligibility

About

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

Full 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.

Enrollment: 848 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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