ProMRI Study of the Iforia ICD System (… | Clinical Trial

Key information

Conditions

Implantable Cardioverter-Defibrillator With Magnetic Resonance Imaging

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patients with a ProMRI ICD System

Device

Tachycardia Fast Heart Beat

Magnetic Resonance Imaging (MRI) Scan

Other

MRI scan of heart/chest or thoracic spine

Primary outcomes

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

Time frame: 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.
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.

Sponsors and collaborators

Lead sponsor

Biotronik, Inc.

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Mar 26, 2014
Registry last updated: Feb 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.