ProMRI Study of the Iforia ICD System (Phase C)

Biotronik

Status: Completed

Conditions: Implantable Cardioverter-Defibrillator With Magnetic Resonance Imaging

Treatments: Other: Magnetic Resonance Imaging (MRI) scan; Device: Patients with a ProMRI ICD System

Study type: Observational

Funder types: Industry

Identifiers

NCT02096692

G120226 (Phase C)

Details and patient eligibility

About

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

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

154 participants in 1 patient group

ICD System Therapy

Description:

Patients with a ProMRI ICD System

Treatment:

Other: Magnetic Resonance Imaging (MRI) scan

Device: Patients with a ProMRI ICD System