Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    02096692
Previous Study | Return to List | Next Study

ProMRI Study of the Iforia ICD System (Phase C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02096692
Recruitment Status : Completed
First Posted : March 26, 2014
Results First Posted : October 22, 2015
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.

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

Condition or disease Intervention/treatment
Implantable Cardioverter-Defibrillator With Magnetic Resonance Imaging Device: Patients with a ProMRI ICD System Other: Magnetic Resonance Imaging (MRI) scan

Layout table for study information
Study Type : Observational
Actual Enrollment : 154 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: ProMRI Study of the Iforia ICD System (Phase C)
Study Start Date : June 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

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




Primary Outcome Measures :
  1. MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate [ Time Frame: 1 Month Post-MRI ]
  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096692


Locations
Layout table for location information
United States, Alabama
Birmingham, Alabama, United States, 35294
United States, Arizona
Phoenix, Arizona, United States, 85018
Scottsdale, Arizona, United States, 85251
United States, California
Concord, California, United States, 94520
Newport Beach, California, United States, 92663
Rancho Mirage, California, United States, 92270
United States, Connecticut
New Haven, Connecticut, United States, 06510
United States, Delaware
Newark, Delaware, United States, 19702
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Indiana
Valparasio, Indiana, United States, 46383
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Louisiana
Lafayette, Louisiana, United States, 70503
United States, Maryland
Cumberland, Maryland, United States, 21502
Takoma, Maryland, United States, 20912
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Burlington, Massachusetts, United States, 01805
Worcester, Massachusetts, United States, 01655
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Grand Rapids, Michigan, United States, 49506
Ypsilanti, Michigan, United States, 48197
United States, Missouri
Kansas City, Missouri, United States, 94520
St. Louis, Missouri, United States, 63110
United States, 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
United States, North Carolina
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Columbus, Ohio, United States, 43210
Toledo, Ohio, United States, 43615
United States, Oregon
Portland, Oregon, United States, 97225
Salem, Oregon, United States, 97301
United States, Pennsylvania
Langhorne, Pennsylvania, United States, 08691
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
Greenville, South Carolina, United States, 29615
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Texas
Amarillo, Texas, United States, 79106
United States, Virginia
Mechanicsville, Virginia, United States, 23116
Virginia Beach, Virginia, United States, 23454
United States, Washington
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Biotronik, Inc.
Publications of Results:
Layout table for additonal information
Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT02096692    
Other Study ID Numbers: G120226 (Phase C)
First Posted: March 26, 2014    Key Record Dates
Results First Posted: October 22, 2015
Last Update Posted: February 29, 2016
Last Verified: February 2016