Cardiac Implantable Electronic Device Magnetic Resonance Imaging Registry

NCT02459379 | Withdrawn FDA Device

• 1 other identifier: IDE G150066
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective registry evaluating the safety of performing magnetic resonance (MRI) scans on patients who have cardiac implanted electronic devices (CIEDs). This includes pacemakers and implantable cardioverter defibrillators (ICDs). This is not a a new device approval or new MRI scanner approval, only for a registry of patients who need to have an MRI scan who already have an FDA approved CIED that is not currently labeled for use in conjunction with an MRI scan. This registry is very similar to the previously approved MagnaSafe Registry that is now closed to new enrollment.

Conditions

Pacemaker Malfunction; Implantable Defibrillator Malfunction

Outcome Measures

Primary Outcomes (2)

• Device function change relative to pre-scan function

  Evaluation of the device post scan and then at 3 months post scan

  Within 1 hour following the MRI Scan and at 3 months following the Scan

• Lead function change relative to pre-scan function

  Evaluation of the lead system 1 hour post scan and then at 3 months post scan

  Within 1 hour following the MRI Scan and at 3 months following the Scan

Interventions

MRI Scan RADIATION

MRI will be performed for clinical reason for which no other imaging study will provide the data required on patients with pacemaker or implantable defibrillator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with CIED that is not labeled as MRI Conditionally Safe that require an MRI scan for their clinical care.

You may qualify if:

• Male or female, age 18 or older
• Permanent pacemaker or ICD (single, dual or multichamber), generator implanted AFTER 2001
• Only non-MRI Conditionally Safe pacemakers and leads (but otherwise approved by the U.S. FDA ) will be included
• Clinical indication for MRI imaging for which no other imaging modality will give adequate results to manage the patient
• Device must have been implanted for 6 weeks or longer
• Patient or patient's advocate must be able and willing to provide informed consent

You may not qualify if:

• Presence of a lead without fixation (e.g. stand-alone SVC coil)
• Presence of abandoned lead(s)
• Presence of non-transvenous lead(s)
• Other contra-indications to MRI scan (e.g. certain metallic implants)
• Has an ICD, is pacemaker dependent, AND device not capable of asynchronous pacing mode
• Battery voltage at replacement time indicator
• Pacemaker or ICD labeled as MRI-Conditionally safe
• Other contra-indication for MRI (e.g. morbid obesity, claustrophobia)
• Pregnant patients
• Systems that include lead adapters
• Patients that have transvenous or transcutaneous temporary pacemaker
• Leadless pacemakers
• Other implants that are not compatible with MRI scans

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: June 2, 2015
• Study Start: June 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: November 9, 2017

Record last verified: 2017-11