Bradycardia, Cardiac Pacemaker, Magnetic Resonance Imaging
Conditions
Keywords
pacemaker, magnetic resonance imaging, MRI conditional, pacemaker leads
Brief 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)
Interventions
PROCEDUREcardiac MRI group
• All subjects of the MRI group will undergo a predefined series of magnetic resonance heart scans ≥ six (6) weeks after device exchange
Sponsors
Boston Scientific Corporation
Dr. Dirk Bastian
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Approved clinical indication for pectoral pacemaker exchange (e.g. elective replacement indication (ERI), end of service (EOS)) * Implantation of a CE certified / market released MRI conditional pacemaker (BSCI) consistent of * a single or dual chamber MRI conditional pacemaker (BSCI) or * Any comparable successor IPG (MRI conditional system, BSCI) compatible with * Implanted Fineline-II-leads (BSCI), MRI conditional * Leads electrically intact and with stable and normal function * The ascertained lead impedance is between 200 and 1500 Ohm. * All pacing capture thresholds (PCT) do not exceed 2.0 V @0.4 or 0.5 ms in pacemaker dependent patients * Adherence to the MRI conditions of use is given * Male or female 18 years or older * Understand the nature of the procedure * Give written informed consent * Able to complete all testing required by the clinical protocol * Ability to measure atrial and/or ventricular pacing threshold(s) at 0.4 or 0.5 ms * Patient body height greater or equal to 140 cm * Pectoral implanted device * Subjects who are able and willing to undergo elective cardiac magnetic resonance (MR) scanning without sedation (MRI-group) * Subjects who are geographically stable and available for follow-up at the study center for the length of the study
Exclusion criteria
* • Non MRI conditional leads implanted * Pacing threshold(s) (at 0.4 or 0.5 ms) and/or sensing amplitude(s) and/or impedance(s) are not measurable * Meet one or more of the contraindications for MRI including Psychiatric disorders, anxiety, claustrophobia Cardiac disorders that represent a contraindication to MRI * Cardiac surgery already scheduled in the next three months * Have other medical implants that may interact with MRI, e.g. abandoned implantable cardioverter defibrillator (ICD) leads or pacemaker leads other than MRI conditional, lead extensions, other active medical devices, non-MRI compatible devices, mechanical valve * Have other metallic artifacts/components in body that may interact with MRI * Subjects for whom a single dose of 1.0 milligram (mg) dexamethasone acetate may be contraindicated * Subjects who require a legally authorized representative to obtain consent * Subjects who are immediate candidates for an ICD * Subjects with medical conditions that preclude the testing required by the protocol or limit study participation * Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during this clinical study * Being pregnant * Have a life expectancy of less than three months * Subjects with
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety: cardiac MRI and pacing system related Serious Adverse Device Effects | 3 months after cardiac MRI | 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. |
| Effectiveness cardiac MRI: cMRI image quality (IQ) and diagnostic value (DV) | cMRI images done ≥ six (6) weeks after device exchange | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pacemaker performance under/after MRI (short and midterm) - Pacing capture threshold (PCT) rise (atrial and ventricular) | 1 and 3 Months after cardiac MRI | * 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 |
| Pacemaker performance under/after MRI (short and midterm): atrial or ventricular sensing amplitude | between Pre-MRI evaluation and at post-MRI interrogation at 1-month and at 3-month follow-up after cMRI | \- 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 |
| - Long term P and R-wave sensing attenuation | between Pre-MRI interrogation and 2 years follow-up | The proportion of patients with an atrial or ventricular amplitude decrease that exceed 50% between Pre-MRI interrogation and 2 years follow-up |
| MRI procedures during long term-follow up | during a minimum of 2 years follow-up | Clinical incidence of MRI procedures during long term-follow up, device performance after repetitive MRI procedures |
| periprocedural cardiac troponin | pre- and within 3 to 24 hours post-MRI | Cardiac high sensitive Troponin pre- and post-MRI as marker of thermal injury |
| - Long term pacing capture threshold rise (atrial and ventricular) | 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 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 |
| cMRI and pacing system related Adverse Device Effect | 1 and 3 months after cardiac MRI | The proportion of patients with a cMRI and pacing system related Adverse Device Effect (ADE) |
Other
| Measure | Time frame | Description |
|---|---|---|
| cMRI periprocedural observations / complaints | during cardiac MRI between pre- and post-MRI pacemaker interrogation | Periprocedural observations / complaints during MRI \- Time interval: during MRI scanning, between pre- and post-MRI pacemaker interrogation |
| IPG dysfunction | after cMRI at any follow-up until the end of the trial (minimum 24 months) | \- Any IPG dysfunction (reset, reprogramming, over/undersensing, over-/underpacing, exit-block, loss of capture…), Battery changes |
Countries
Germany
Outcome results
None listed