Cardiac MRI After Pacemaker Replacement

NCT02195024 | Terminated Phase 4

• 1 other identifier: PMUN-DB-001-MRIPM
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Bradycardia; Cardiac Pacemaker; Magnetic Resonance Imaging

Keywords

pacemaker; magnetic resonance imaging; MRI conditional; pacemaker leads

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  cMRI images done ≥ six (6) weeks after device exchange

Secondary Outcomes (7)

• cMRI and pacing system related Adverse Device Effect

  1 and 3 months after cardiac MRI

• Pacemaker performance under/after MRI (short and midterm) - Pacing capture threshold (PCT) rise (atrial and ventricular)

  1 and 3 Months after cardiac MRI

• 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

• - 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

  between Pre-MRI interrogation and 2 years follow-up

Other Outcomes (2)

• cMRI periprocedural observations / complaints

  during cardiac MRI between pre- and post-MRI pacemaker interrogation

• IPG dysfunction

  after cMRI at any follow-up until the end of the trial (minimum 24 months)

Study Arms (2)

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

Procedure: cardiac MRI group

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

Interventions

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

cardiac MRI group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Dirk Bastian: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Klinikum Nürnberg Süd

Nuremberg, D-90471, Germany

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dirk Bastian, MD

  Paracelsus Medical University Nürnberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 21, 2014
• Study Start: July 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

DE (1)