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.
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)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
23
• All subjects of the MRI group will undergo a predefined series of magnetic resonance heart scans ≥ six (6) weeks after device exchange
Klinikum Nürnberg Süd
Nuremberg, Germany
safety: cardiac MRI and pacing system related Serious Adverse Device Effects
Primary outcome measure 1 (safety): * cMRI and pacing system related Serious Adverse Device Effect (SADE) free rate after 3 months. * Hypothesis: MRI and pacing system related Serious Adverse Device Effect (SADE) free-Rate is greater than 90% after 3 months.
Time frame: 3 months after cardiac MRI
Effectiveness cardiac MRI: cMRI image quality (IQ) and diagnostic value (DV)
Primary outcome measure 2 (Effectiveness cardiac MRI): * cMRI image quality (IQ) and diagnostic value (DV) * Hypothesis: cMRI IQ is "acceptable" and clinical use is not adversely affected in ≥ 90% cMRI procedures
Time frame: cMRI images done ≥ six (6) weeks after device exchange
cMRI and pacing system related Adverse Device Effect
The proportion of patients with a cMRI and pacing system related Adverse Device Effect (ADE)
Time frame: 1 and 3 months after cardiac MRI
Pacemaker performance under/after MRI (short and midterm) - Pacing capture threshold (PCT) rise (atrial and ventricular)
* The proportion of patients with an atrial or ventricular MRI induced pacing capture threshold rise larger than or equal to 100% voltage safety margin of the measured Pre-MRI pacing threshold at post-MRI interrogation, at 1-month and at 3 month follow- up * The proportion of patients with an atrial or ventricular MRI induced pacing threshold rise larger than or equal to 1.0 V @ 0.4 ms or 0.5 ms between pre-MRI and at post-MRI interrogation, 1 month and at 3-month follow-up
Time frame: 1 and 3 Months after cardiac MRI
Pacemaker performance under/after MRI (short and midterm): atrial or ventricular sensing amplitude
\- P and R-wave sensing attenuation: o The proportion of patients with an atrial or ventricular amplitude decrease that exceed 50% between Pre-MRI evaluation and at post-MRI interrogation, at 1-month and at 3-month follow-up
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Time frame: between Pre-MRI evaluation and at post-MRI interrogation at 1-month and at 3-month follow-up after cMRI
- Long term pacing capture threshold rise (atrial and ventricular)
* The proportion of patients with an atrial or ventricular MRI induced pacing capture threshold rise larger than or equal to 100% voltage safety margin of the measured Pre-MRI pacing threshold between Pre-MRI interrogation and at 2 years follow- up * The proportion of patients with an atrial or ventricular MRI induced pacing capture threshold rise larger than or equal to 1.0 V @ 0.4 ms or 0.5 ms between Pre-MRI interrogation and at 2 years follow- up
Time frame: Pre-MRI interrogation and at 2 years follow- up
- Long term P and R-wave sensing attenuation
The proportion of patients with an atrial or ventricular amplitude decrease that exceed 50% between Pre-MRI interrogation and 2 years follow-up
Time frame: between Pre-MRI interrogation and 2 years follow-up
MRI procedures during long term-follow up
Clinical incidence of MRI procedures during long term-follow up, device performance after repetitive MRI procedures
Time frame: during a minimum of 2 years follow-up
periprocedural cardiac troponin
Cardiac high sensitive Troponin pre- and post-MRI as marker of thermal injury
Time frame: pre- and within 3 to 24 hours post-MRI