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BradycardiaPhase 4MRI-rePACENCT02195024

Cardiac MRI After Pacemaker Replacement

A Phase 4 study testing cardiac MRI group in people with Bradycardia and Cardiac Pacemaker, run by Dr. Dirk Bastian at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cardiac MRI group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteGermany
Study dates
Jul 2014to May 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • • 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
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  • 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)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Klinikum Nürnberg Süd

    Nuremberg, D-90471

Other trials in Germany

About this study

Official title: Cardiac MRI After Replacement of Long Term Implanted PACEmakers by a MRI Conditional Pulse Generator (MRI-rePace)

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.

Read the 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.
  4. To evaluate the clinical incidence of MRI procedures in the population of long term implanted pacemaker patients (long term-follow up)
Being tested
cardiac MRI group
Keywords
pacemaker, magnetic resonance imaging, MRI conditional, pacemaker leads
Medical subject headings
Bradycardia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cardiac MRI groupProcedure or surgery

    • All subjects of the MRI group will undergo a predefined series of magnetic resonance heart scans ≥ six (6) weeks after device exchange
Study groups in NCT02195024
Study groupRoleWhat they receive
cardiac MRI groupActive comparator• All subjects of the MRI group will undergo a predefined series of magnetic resonance heart scans ≥ six (6) weeks after device exchange
Receives: Procedure: cardiac MRI group
No MRI groupNo interventionPatients that refuse to undergo cMRI for any reason but accept to attend the trial can be further observed according to the protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months after cardiac MRI

  2. 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

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

Secondary outcomes (7)

  1. cMRI and pacing system related Adverse Device Effect

    The proportion of patients with a cMRI and pacing system related Adverse Device Effect (ADE)

    Measured: 1 and 3 months after cardiac MRI

  2. 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

    Measured: 1 and 3 Months after cardiac MRI

  3. Pacemaker performance under/after MRI (short and midterm): atrial or ventricular sensing amplitude

    • P and R-wave sensing attenuation:
    • 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

    Measured: between Pre-MRI evaluation and at post-MRI interrogation at 1-month and at 3-month follow-up after cMRI

  4. - 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

    Measured: Pre-MRI interrogation and at 2 years follow- up

  5. - 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

    Measured: between Pre-MRI interrogation and 2 years follow-up

  6. MRI procedures during long term-follow up

    Clinical incidence of MRI procedures during long term-follow up, device performance after repetitive MRI procedures

    Measured: during a minimum of 2 years follow-up

  7. periprocedural cardiac troponin

    Cardiac high sensitive Troponin pre- and post-MRI as marker of thermal injury

    Measured: pre- and within 3 to 24 hours post-MRI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionMay 2017
  4. Study completionMay 2017

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02195024
Sponsor's protocol ID
PMUN-DB-001-MRIPM
Acronym
MRI-rePACE
Status last verified
Jan 2021
First submitted
17 Jul 2014
Last updated
12 Jan 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing cardiac MRI group in people with Bradycardia and Cardiac Pacemaker, run by Dr. Dirk Bastian at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

safety: cardiac MRI and pacing system related Serious Adverse Device Effects (time frame: 3 months after cardiac MRI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02195024.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.

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