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Implantable Cardioverter-Defibrillator With Magnetic Resonance ImagingNCT02096692

ProMRI Study of the Iforia ICD System (Phase C)

An observational study of Implantable Cardioverter-Defibrillator With Magnetic Resonance Imaging, run by Biotronik, Inc. at 39 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI ICD System when used under specific MRI conditions. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Patients with a ProMRI ICD System and Magnetic Resonance Imaging (MRI) scan
Type of treatment
Medical device
How many people
154 participants
Where
39 sitesUnited States
Study dates
Jun 2014to Jun 2015
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Study population: The patients selected for participation should be from the investigators' general patient population according to the inclusion and exclusion criteria.

Who may be able to join

  • The following initial inclusion criteria must be met for a subject to be enrolled and considered for the MRI-procedure:
  • Age greater than or equal to 18 years
  • Able and willing to complete MRI testing
  • Able to provide written informed consent
  • Available for follow-up visit at the study site
  • Implanted with an ICD System consisting only of an Iforia DR-T and Linoxsmart S 65 / Linoxsmart SD 65/18 with Setrox S 53 atrial lead or Iforia VR-T DX and Linoxsmart S DX 65/15 or Linoxsmart S DX 65/17.
Show all 25Show fewer
  • ICD implanted pectorally
  • All ICD system components implanted, repositioned, or exchanged at least 5 weeks prior to enrollment
  • Underlying rhythm identifiable during sensing test
  • All pacing thresholds are measureable and are less than or equal to 2.0 V @ 0.4 ms (Criterion does not apply to atrial pacing threshold for subjects with an Iforia DR-T that have AF and are permanently programmed to VVI and for subjects with an Iforia VR-T DX)
  • Ventricular sensing is measurable and >6.5mV
  • Absence of phrenic nerve stimulation at 5.0V and 1.0 ms
  • Pacing impedance is between 200 and 1500 ohm
  • Shock Impedance is between 30 and 90 ohm
  • Able and willing to use the CardioMessenger II
  • At the pre-MRI procedure, the following procedure-related criteria must be met for the subject to undergo the MRI scan:
  • Absence of phrenic nerve stimulation at 5.0V @ 1.0 ms
  • |pacing threshold at Pre-MRI follow-up - pacing threshold at baseline| ≤ 0.5 V (ICD Lead Only)
  • All pacing thresholds are measureable and are less than or equal to 2.0 V @ 0.4 ms (Criterion does not apply to atrial pacing threshold for subjects with an Iforia DR-T that have AF and are permanently programmed to VVI and for subjects with an Iforia VR-T DX.)
  • Ventricular sensing is measurable and >6.5mV
  • The ICD system has been implanted for at least six weeks.
  • Subject did not have an ICD or lead explant, exchange or reposition in the previous 6 weeks.
  • All lead pacing impedances are between 200 and 1500 ohm
  • Shock impedance is between 30 and 90 ohm
  • Battery status is at least 30% of capacity

Who cannot join

None listed.

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • Study site

    Amarillo, Texas, 79106

  • Study site

    Ann Arbor, Michigan, 48109

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Burlington, Massachusetts, 01805

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Concord, California, 94520

  • Study site

    Cumberland, Maryland, 21502

  • Study site

    Flushing, New York, 11355

  • Study site

    Grand Rapids, Michigan, 49506

  • Study site

    Greenville, South Carolina, 29615

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Kansas City, Missouri, 94520

  • Study site

    Lafayette, Louisiana, 70503

  • Study site

    Langhorne, Pennsylvania, 08691

  • Study site

    Mechanicsville, Virginia, 23116

  • Study site

    Nashville, Tennessee, 37232

  • Study site

    New Haven, Connecticut, 06510

  • Study site

    New York, New York, 10016

  • Study site

    New York, New York, 10021

  • Study site

    Newark, Delaware, 19702

  • Study site

    Newport Beach, California, 92663

  • Study site

    Phoenix, Arizona, 85018

  • Study site

    Portland, Oregon, 97225

  • Study site

    Rancho Mirage, California, 92270

  • Study site

    Salem, Oregon, 97301

  • Study site

    Scottsdale, Arizona, 85251

  • Study site

    Spokane, Washington, 99204

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Takoma Park, Maryland, 20912

  • Study site

    The Bronx, New York, 10463

  • Study site

    Toledo, Ohio, 43615

  • Study site

    Valparasio, Indiana, 46383

  • Study site

    Virginia Beach, Virginia, 23454

  • Study site

    Washington D.C., District of Columbia, 20010

  • Study site

    Winston-Salem, North Carolina, 27157

  • Study site

    Worcester, Massachusetts, 01655

  • Study site

    Wynnewood, Pennsylvania, 19096

  • Study site

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI ICD System when used under specific MRI conditions.

Being tested
Patients with a ProMRI ICD System, Magnetic Resonance Imaging (MRI) scan

What participants receive

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

  • Patients with a ProMRI ICD SystemDevice

    Tachycardia Fast Heart Beat

  • Magnetic Resonance Imaging (MRI) scanOther

    MRI scan of heart/chest or thoracic spine

Study groups in NCT02096692
Study groupRoleWhat they receive
ICD System TherapyPatients with a ProMRI ICD System
Receives: Device: Patients with a ProMRI ICD System; Other: Magnetic Resonance Imaging (MRI) scan

What is being measured

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

  1. MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate

    Measured: 1 Month Post-MRI

  2. Percentage of Participants Free of Ventricular Pacing Threshold Rise

    Evaluate the percentage of ICD leads free of ventricular pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.

    Measured: Between Pre-MRI and 1 Month Post-MRI

  3. Percentage of Participants Free of R-wave Sensing Attenuation

    Evaluate the percentage of subjects free of R-wave attenuation between the Pre-MRI and one-month post-MRI follow-up.

    Measured: Between Pre-MRI and 1 Month 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 posted26 Mar 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionMar 2015
  4. Study completionJun 2015

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02096692
Sponsor's protocol ID
G120226 (Phase C)
Status last verified
Feb 2016
First submitted
24 Mar 2014
Last updated
29 Feb 2016
Data monitoring committee
Yes

Publications

  • Awad K, Griffin J, Crawford TC, Lane Cox S, Ferrick K, Mazur A, Pena RE, Lloyd SG, Michalski J, Johnson W, Bailey WM. Clinical safety of the Iforia implantable cardioverter-defibrillator system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions. Heart Rhythm. 2015 Oct;12(10):2155-61. doi: 10.1016/j.hrthm.2015.06.002. Epub 2015 Jun 3.

    PubMed 26049048

Questions about this trial

What is this clinical trial studying?

An observational study of Implantable Cardioverter-Defibrillator With Magnetic Resonance Imaging, run by Biotronik, Inc. at 39 sites in United States.

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 25 inclusion and 0 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: finished, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate (time frame: 1 Month Post-MRI). The study lists 3 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 NCT02096692, which also lists 1 linked publication.

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 29 Feb 2016.

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