Registry of Patients for MRI With Non-MRI Conditional Pacemakers and ICD Non-MRI Conditional Pacemakers and ICD

NCT02318550 | Completed Results DMC

• 1 other identifier: 2014-68
• Study Type: observational
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the registry is to accumulate pre-and post-scan device interrogation data for the purpose of determining the risk of MRI for patients with implantable devices.

Conditions

MRI Scans; Magnetic Resonance Imaging; Pacemaker; Implantable Cardioverter Defibrillator

Outcome Measures

Primary Outcomes (10)

• Number of Participants With Burning or Pulling Sensations in Chest/Device Pocket During MRI

  Through procedure completion, an average of 1 hour

• Number of Participants With Potentially Lethal/Previously Non-diagnosed Arrhythmias During MRI

  Through procedure completion, an average of 1 hour

• Number of Participants With Spontaneous and Unanticipated Pacing Rate Change

  Through procedure completion, an average of 1 hour

• Number of Participants With Power on Reset of Pacemaker or ICD

  Through procedure completion, an average of 1 hour

• Number of Participants With MRI Related Device Malfunction/Failure

  Through procedure completion, an average of 1 hour

• Number of Participants With Serious Injury/Death Related to MRI Device Malfunction/Failure

  Through procedure completion, an average of 1 hour

• Number of MRI Scans With Post-MRI Device Parameter Change: Greater Than 50 Ohm Change in Atrial or Ventricular (RV and/or LV) Lead Impedance

  Through procedure completion, an average of 1 hour

• Number of MRI Scans With Post-MRI Device Parameter Changes: Greater Than 5 Ohm Change in High Voltage Lead Impedance

  Through procedure completion, an average of 1 hour

• Number of MRI Scans With Post-MRI Device Parameter Changes: Greater Than 50% Decrease in Atrial or Ventricular (RV and/or LV) Sensing Threshold

  Through procedure completion, an average of 1 hour

• Number of MRI Scans With Post-MRI Device Parameter Changes: Greater Than or Equal to a 1 Volt Increase in Atrial or Ventricular (RV and/or LV) Pacing Threshold

  Through procedure completion, an average of 1 hour

Interventions

MRI Scan OTHER

The MRI will be performed with a 1.5 T scanner utilizing institutional protocols and the following settings: * Normal operating mode * SAR ≤ 2.0 W/kg per patient.

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

Any patient with any commercially available pacemaker or ICD system implanted after 2001 who meet all of the inclusion criteria and none of the exclusion criteria, and who require a non-cardiac, medically-indicated MRI as described above will be eligible to enroll in the study.

You may not qualify if:

• Non-device related contraindication for MRI (such as implanted metallic objects, claustrophobia, morbid obesity)
• Presence of capped/abandoned/epicardial leads or subcutaneous coil
• Pregnancy
• Device generator at elective replacement interval
• Abdominal device implant

Sponsors & Collaborators

• Lancaster General Hospital: lead

Study Sites (1)

Lancaster General Hospital

Lancaster, Pennsylvania, 17604, United States

Location

Related Publications (5)

• Mollerus M, Albin G, Lipinski M, Lucca J. Ectopy in patients with permanent pacemakers and implantable cardioverter-defibrillators undergoing an MRI scan. Pacing Clin Electrophysiol. 2009 Jun;32(6):772-8. doi: 10.1111/j.1540-8159.2009.02364.x.

  PMID: 19545340 BACKGROUND

• Nazarian S, Hansford R, Roguin A, Goldsher D, Zviman MM, Lardo AC, Caffo BS, Frick KD, Kraut MA, Kamel IR, Calkins H, Berger RD, Bluemke DA, Halperin HR. A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. Ann Intern Med. 2011 Oct 4;155(7):415-24. doi: 10.7326/0003-4819-155-7-201110040-00004.

  PMID: 21969340 BACKGROUND

• Nazarian S, Roguin A, Zviman MM, Lardo AC, Dickfeld TL, Calkins H, Weiss RG, Berger RD, Bluemke DA, Halperin HR. Clinical utility and safety of a protocol for noncardiac and cardiac magnetic resonance imaging of patients with permanent pacemakers and implantable-cardioverter defibrillators at 1.5 tesla. Circulation. 2006 Sep 19;114(12):1277-84. doi: 10.1161/CIRCULATIONAHA.105.607655. Epub 2006 Sep 11.

  PMID: 16966586 BACKGROUND

• Nazarian S, Beinart R, Halperin HR. Magnetic resonance imaging and implantable devices. Circ Arrhythm Electrophysiol. 2013 Apr;6(2):419-28. doi: 10.1161/CIRCEP.113.000116. No abstract available.

  PMID: 23592868 BACKGROUND

• Ferreira AM, Costa F, Tralhao A, Marques H, Cardim N, Adragao P. MRI-conditional pacemakers: current perspectives. Med Devices (Auckl). 2014 May 7;7:115-24. doi: 10.2147/MDER.S44063. eCollection 2014.

  PMID: 24851058 BACKGROUND

Related Links

• Magna Safe Registry

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Project Manager
• Organization: Lancaster General Health

Tawnya.Vernon@pennmedicine.upenn.edu

7175447395

Study Officials

• Sandeep Bansal, MD

  Lancaster General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 17, 2014
• Study Start: December 1, 2014
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: August 31, 2021
• Results First Posted: May 17, 2021

Record last verified: 2021-08

Locations

US (1)