Clinical trial NCT02195024: Cardiac MRI After Pacemaker Replacement
Official title: Cardiac MRI After Replacement of Long Term Implanted PACEmakers by a MRI Conditional Pulse Generator (MRI-rePace)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Bradycardia
Cardiac Pacemaker
Magnetic Resonance Imaging
Keywords: pacemaker
magnetic resonance imaging
MRI conditional
pacemaker leads
Lead sponsor: Paracelsus Medical University
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2014-07-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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)

Eligibility criteria: 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 exclusion criteria required by local law (e.g. age, breastfeeding)

Primary outcomes:
measure: safety: cardiac MRI and pacing system related Serious Adverse Device Effects
timeFrame: 3 months after cardiac MRI
measure: Effectiveness cardiac MRI: cMRI image quality (IQ) and diagnostic value (DV)
timeFrame: cMRI images done ≥ six (6) weeks after device exchange
Secondary outcomes:
measure: cMRI and pacing system related Adverse Device Effect
timeFrame: 1 and 3 months after cardiac MRI
measure: Pacemaker performance under/after MRI (short and midterm) - Pacing capture threshold (PCT) rise (atrial and ventricular)
timeFrame: 1 and 3 Months after cardiac MRI
measure: Pacemaker performance under/after MRI (short and midterm): atrial or ventricular sensing amplitude
timeFrame: between Pre-MRI evaluation and at post-MRI interrogation at 1-month and at 3-month follow-up after cMRI
measure: - Long term pacing capture threshold rise (atrial and ventricular)
timeFrame: Pre-MRI interrogation and at 2 years follow- up
measure: - Long term P and R-wave sensing attenuation
timeFrame: between Pre-MRI interrogation and 2 years follow-up
measure: MRI procedures during long term-follow up
timeFrame: during a minimum of 2 years follow-up
measure: periprocedural cardiac troponin
timeFrame: pre- and within 3 to 24 hours post-MRI
Other outcomes:
measure: cMRI periprocedural observations / complaints
timeFrame: during cardiac MRI between pre- and post-MRI pacemaker interrogation
measure: IPG dysfunction
timeFrame: after cMRI at any follow-up until the end of the trial (minimum 24 months)
Locations:
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Süd
Study officials:
affiliation: Paracelsus Medical University Nürnberg
name: Dirk Bastian, MD
role: PRINCIPAL_INVESTIGATOR
References: