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PI changed affiliation not beening allowed to continue the trial in further cooperation. The sub-investigators did not see any option to continue the trial and made the decision to terminate the study.
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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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
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.
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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cardiac MRI group | Active Comparator | • All subjects of the MRI group will undergo a predefined series of magnetic resonance heart scans ≥ six (6) weeks after device exchange |
|
| No MRI group | No Intervention | Patients that refuse to undergo cMRI for any reason but accept to attend the trial can be further observed according to the protocol |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cardiac MRI group | Procedure | • All subjects of the MRI group will undergo a predefined series of magnetic resonance heart scans ≥ six (6) weeks after device exchange |
|
| Measure | Description | Time Frame |
|---|---|---|
| safety: cardiac MRI and pacing system related Serious Adverse Device Effects | Primary outcome measure 1 (safety):
| 3 months after cardiac MRI |
| Effectiveness cardiac MRI: cMRI image quality (IQ) and diagnostic value (DV) | Primary outcome measure 2 (Effectiveness cardiac MRI):
| cMRI images done ≥ six (6) weeks after device exchange |
| Measure | Description | Time Frame |
|---|---|---|
| cMRI and pacing system related Adverse Device Effect | The proportion of patients with a cMRI and pacing system related Adverse Device Effect (ADE) | 1 and 3 months after cardiac MRI |
| Pacemaker performance under/after MRI (short and midterm) - Pacing capture threshold (PCT) rise (atrial and ventricular) |
| Measure | Description | Time Frame |
|---|---|---|
| cMRI periprocedural observations / complaints | Periprocedural observations / complaints during MRI - Time interval: during MRI scanning, between pre- and post-MRI pacemaker interrogation | during cardiac MRI between pre- and post-MRI pacemaker interrogation |
| IPG dysfunction |
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
Implanted Fineline-II-leads (BSCI), MRI conditional
Leads electrically intact and with stable and normal function
Adherence to the MRI conditions of use is given
Exclusion Criteria:
• Non MRI conditional leads implanted
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| Name | Affiliation | Role |
|---|---|---|
| Dirk Bastian, MD | Paracelsus Medical University Nürnberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Nürnberg Süd | Nuremberg | D-90471 | Germany |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| 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 | 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) |
| 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 | 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 | during a minimum of 2 years follow-up |
| periprocedural cardiac troponin | Cardiac high sensitive Troponin pre- and post-MRI as marker of thermal injury | pre- and within 3 to 24 hours post-MRI |
- Any IPG dysfunction (reset, reprogramming, over/undersensing, over-/underpacing, exit-block, loss of capture…), Battery changes |
| after cMRI at any follow-up until the end of the trial (minimum 24 months) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |