ProMRI Study of the Iforia ICD System (Phase C)

February 1, 2016 updated by: Biotronik, Inc.
The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI ICD System when used under specific MRI conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

154

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • Arizona
      • Phoenix, Arizona, United States, 85018
      • Scottsdale, Arizona, United States, 85251
    • California
      • Concord, California, United States, 94520
      • Newport Beach, California, United States, 92663
      • Rancho Mirage, California, United States, 92270
    • Connecticut
      • New Haven, Connecticut, United States, 06510
    • Delaware
      • Newark, Delaware, United States, 19702
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Indiana
      • Valparasio, Indiana, United States, 46383
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
    • Maryland
      • Cumberland, Maryland, United States, 21502
      • Takoma, Maryland, United States, 20912
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Burlington, Massachusetts, United States, 01805
      • Worcester, Massachusetts, United States, 01655
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
      • Grand Rapids, Michigan, United States, 49506
      • Ypsilanti, Michigan, United States, 48197
    • Missouri
      • Kansas City, Missouri, United States, 94520
      • St. Louis, Missouri, United States, 63110
    • New York
      • Bronx, New York, United States, 10463
      • Flushing, New York, United States, 11355
      • New York, New York, United States, 10016
      • New York, New York, United States, 10021
    • North Carolina
      • Winston Salem, North Carolina, United States, 27157
    • Ohio
      • Columbus, Ohio, United States, 43210
      • Toledo, Ohio, United States, 43615
    • Oregon
      • Portland, Oregon, United States, 97225
      • Salem, Oregon, United States, 97301
    • Pennsylvania
      • Langhorne, Pennsylvania, United States, 08691
      • Wynnewood, Pennsylvania, United States, 19096
    • South Carolina
      • Greenville, South Carolina, United States, 29615
    • Tennessee
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Amarillo, Texas, United States, 79106
    • Virginia
      • Mechanicsville, Virginia, United States, 23116
      • Virginia Beach, Virginia, United States, 23454
    • Washington
      • Spokane, Washington, United States, 99204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ICD System Therapy
Patients with a ProMRI ICD System
Device: Patients with a ProMRI ICD System
Tachycardia Fast Heart Beat
Other: Magnetic Resonance Imaging (MRI) scan
MRI scan of heart/chest or thoracic spine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate
Time Frame: 1 Month Post-MRI
1 Month Post-MRI
Percentage of Participants Free of Ventricular Pacing Threshold Rise
Time Frame: Between Pre-MRI and 1 Month Post-MRI
Evaluate the percentage of ICD leads free of ventricular pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.
Between Pre-MRI and 1 Month Post-MRI
Percentage of Participants Free of R-wave Sensing Attenuation
Time Frame: Between Pre-MRI and 1 Month Post-MRI
Evaluate the percentage of subjects free of R-wave attenuation between the Pre-MRI and one-month post-MRI follow-up.
Between Pre-MRI and 1 Month Post-MRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

March 25, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Estimate)

February 29, 2016

Last Update Submitted That Met QC Criteria

February 1, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • G120226 (Phase C)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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