NCT02195024

Cardiac MRI After Pacemaker Replacement

Cardiac MRI After Replacement of Long Term Implanted PACEmakers by a MRI Conditional Pulse Generator (MRI-rePace)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Dr. Dirk Bastian · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aim of this trial is to investigate feasibility of cardiac magnetic resonance imaging (cMRI) in patients with long term implanted coradial leads upgraded to an MRI conditional pacemaker system, to assess MR-image quality and to prove the safety of MRI in this specific population in the short term as well as during long term follow-up.

Detailed description

The trial is designed 1. To investigate the cardiac MRI related adverse event-free rate in patients with long term implanted coradial pacing leads (Fineline-II) after implantable pulse generator (IPG) exchange to a MRI conditional system (short term and long term): Safety. 2. To assess the technical performance of MRI conditional pacemaker systems with long term implanted coradial pacing leads, for cardiac MRI (short term and long term): Effectiveness pacemaker. 3. To assess the image quality (IQ) and the diagnostic value (DV) of the cardiac MRI scans in patients with implanted MRI conditional systems: Effectiveness cardiac MRI. 2\) To evaluate the clinical incidence of MRI procedures in the population of long term implanted pacemaker patients (long term-follow up)

Conditions

• Bradycardia
• Cardiac Pacemaker
• Magnetic Resonance Imaging

Interventions

Type	Name	Description
PROCEDURE	cardiac MRI group	• All subjects of the MRI group will undergo a predefined series of magnetic resonance heart scans ≥ six (6) weeks after device exchange

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2014-07-21
• Last updated: 2021-01-12

Locations

1 site across 1 country: Germany