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Cardiac MRI After Pacemaker Replacement (MRI-rePACE)

Primary Purpose

Bradycardia, Cardiac Pacemaker, Magnetic Resonance Imaging

Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
cardiac MRI group
Sponsored by
Dr. Dirk Bastian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bradycardia focused on measuring pacemaker, magnetic resonance imaging, MRI conditional, pacemaker leads

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Klinikum Nürnberg Süd

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

cardiac MRI group

No MRI group

Arm Description

• All subjects of the MRI group will undergo a predefined series of magnetic resonance heart scans ≥ six (6) weeks after device exchange

Patients that refuse to undergo cMRI for any reason but accept to attend the trial can be further observed according to the protocol

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

cMRI and pacing system related Adverse Device Effect
The proportion of patients with a cMRI and pacing system related Adverse Device Effect (ADE)
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
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
- 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
- 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
MRI procedures during long term-follow up
Clinical incidence of MRI procedures during long term-follow up, device performance after repetitive MRI procedures
periprocedural cardiac troponin
Cardiac high sensitive Troponin pre- and post-MRI as marker of thermal injury

Full Information

First Posted
July 17, 2014
Last Updated
January 9, 2021
Sponsor
Dr. Dirk Bastian
Collaborators
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02195024
Brief Title
Cardiac MRI After Pacemaker Replacement
Acronym
MRI-rePACE
Official Title
Cardiac MRI After Replacement of Long Term Implanted PACEmakers by a MRI Conditional Pulse Generator (MRI-rePace)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
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.
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Dirk Bastian
Collaborators
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia, Cardiac Pacemaker, Magnetic Resonance Imaging
Keywords
pacemaker, magnetic resonance imaging, MRI conditional, pacemaker leads

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cardiac MRI group
Arm Type
Active Comparator
Arm Description
• All subjects of the MRI group will undergo a predefined series of magnetic resonance heart scans ≥ six (6) weeks after device exchange
Arm Title
No MRI group
Arm Type
No Intervention
Arm Description
Patients that refuse to undergo cMRI for any reason but accept to attend the trial can be further observed according to the protocol
Intervention Type
Procedure
Intervention Name(s)
cardiac MRI group
Intervention Description
• All subjects of the MRI group will undergo a predefined series of magnetic resonance heart scans ≥ six (6) weeks after device exchange
Primary Outcome Measure Information:
Title
safety: cardiac MRI and pacing system related Serious Adverse Device Effects
Description
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
Title
Effectiveness cardiac MRI: cMRI image quality (IQ) and diagnostic value (DV)
Description
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
Secondary Outcome Measure Information:
Title
cMRI and pacing system related Adverse Device Effect
Description
The proportion of patients with a cMRI and pacing system related Adverse Device Effect (ADE)
Time Frame
1 and 3 months after cardiac MRI
Title
Pacemaker performance under/after MRI (short and midterm) - Pacing capture threshold (PCT) rise (atrial and ventricular)
Description
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
Title
Pacemaker performance under/after MRI (short and midterm): atrial or ventricular sensing amplitude
Description
- 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
Time Frame
between Pre-MRI evaluation and at post-MRI interrogation at 1-month and at 3-month follow-up after cMRI
Title
- Long term pacing capture threshold rise (atrial and ventricular)
Description
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
Title
- Long term P and R-wave sensing attenuation
Description
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
Title
MRI procedures during long term-follow up
Description
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
Title
periprocedural cardiac troponin
Description
Cardiac high sensitive Troponin pre- and post-MRI as marker of thermal injury
Time Frame
pre- and within 3 to 24 hours post-MRI
Other Pre-specified Outcome Measures:
Title
cMRI periprocedural observations / complaints
Description
Periprocedural observations / complaints during MRI - Time interval: during MRI scanning, between pre- and post-MRI pacemaker interrogation
Time Frame
during cardiac MRI between pre- and post-MRI pacemaker interrogation
Title
IPG dysfunction
Description
- Any IPG dysfunction (reset, reprogramming, over/undersensing, over-/underpacing, exit-block, loss of capture…), Battery changes
Time Frame
after cMRI at any follow-up until the end of the trial (minimum 24 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Bastian, MD
Organizational Affiliation
Paracelsus Medical University Nürnberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Nürnberg Süd
City
Nürnberg
ZIP/Postal Code
D-90471
Country
Germany

12. IPD Sharing Statement

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Cardiac MRI After Pacemaker Replacement

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