Suspended

Clinical Evaluation of the Sorin Group's REPLY MR-conditional Pacing System

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

MRI exam

+ control

Procedure
Who is being recruted

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 3
Interventional
Study Start: January 2012
See protocol details

Summary

Principal SponsorLivaNova
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2012

Actual date on which the first participant was enrolled.

Permanent cardiac pacemakers have represented a contraindication to Magnetic Resonance Imaging (MRI). Strong static, gradient and radiofrequency fields used for MRI are thought to be detrimental to pacemaker function and possibly cause harm to patients undergoing MRI examinations. A previous study has shown that MRI is indicated in 17% of all patients with pacemakers within 12 months of device placement , which demonstrates the need of practical, safe approach for performing MRI on pacemaker patients. A new Reply MR-conditional pacing system is developed by Sorin Group for safe use in the MRI environment. The new pacing system is composed by the Reply pacemaker and the Filtrea bradycardia pacing leads. This study intends to demonstrate the safety and the efficacy in the MRI environment of the Sorin Group Reply MR-conditional pacing system.

Official TitleClinical Evaluation of the Sorin Group's REPLY MR-conditional Pacing System
NCT01341522
Principal SponsorLivaNova
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Patients who are candidates for dual-chamber pacemaker primo-implantation
Patients who have indication for implantation of a dual-chamber pacemaker according to the American College of Cardiology and the American Heart Association
Patients who are able and willing to undergo elective MRI scanning
Patients who are scheduled for implant of a Reply DR pacemaker and Filtrea lead(s) only
Show More Criteria
12 exclusion criteria prevent from participating
Non MR-compatible device or material implant
Chronic atrial fibrillation (for atrial lead evaluation)
Incessant ventricular tachyarrhythmia (for ventricular lead evaluation)
Inability to understand the purpose of the study or refusal to co-operate
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
experimental

Group II

Active Comparator
Control

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
SuspendedNo study centers