Trial record 4 of 7 for:    Open Studies | artificial pacemaker

Study to Monitor Patients With Pacemakers or ICDs Who Undergo MRI Scans

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Essentia Health
Sponsor:
Information provided by (Responsible Party):
Michael Mollerus, Essentia Health
ClinicalTrials.gov Identifier:
NCT01999751
First received: November 26, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

This study is a prospective, non-randomized, unblinded case series of patients with permanent pacemakers and implantable cardioverter-defibrillators undergoing medically-required magnetic resonance imaging (MRI) scanning, at St. Mary's Medical Center, Essentia Health. Patients will be enrolled over a 60-month period and followed for 12 months, with data collected to evaluate the study's primary endpoint, change in pacing thresholds over time, as well as a series of secondary endpoints, including: adverse events, symptoms, need to make pacemaker programming changes, and possible artifacts created by the pacemaker systems on the MRI scans. This study will allow for carefully monitoring of the safety MRI scanning in this population and improve practice models and protocols in the future.


Condition Intervention
Arrhythmias, Cardiac
Safety
Device: MRI Scan

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: SMDC CRM-MRI Prospective Case Series

Resource links provided by NLM:


Further study details as provided by Essentia Health:

Primary Outcome Measures:
  • Pacing threshold increase [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Any change greater than 1 V at a pulse width of 0.5 msec in a pacemaker or implantable cardioverter-defibrillator lead at any time within 12 months of the MRI scan


Secondary Outcome Measures:
  • Ectopy [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    Increased cardiac ectopy at the time of the MRI scan

  • Pacemaker reprogramming [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Unanticipated pacemaker or implantable cardioverter-defibrillator reprogramming because of alterations in device behavior possibly related to the MRI scan


Estimated Enrollment: 500
Study Start Date: October 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
MRI Scan
Patients with implantable cardioverter-defibrillator or pacemaker who undergo an MRI scan
Device: MRI Scan
Clinically indicated MRI scan of patients with pacemaker or implantable cardioverter-defibrillator in situ.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any person followed at St. Mary's Medical Center, Duluth, MN, with a permanent pacemaker or implantable cardioverter-defibrillator implanted for at least 6 weeks, referred for a medically-required MRI scan by a physician or provider not participating in the trial. If patients elect not to participate, they may still receive an MRI and will sign the clinical consent. If they elect not to have an MRI, they will be referred back to the ordering provider to discuss other options.

Criteria

Inclusion Criteria:

  1. Permanent Pacemaker or ICD implanted for at least 6 weeks
  2. Referred for medically-required MRI scan
  3. Age greater than or equal to 18 years

Exclusion Criteria:

  1. ICD market released before 2001 including GDT Ventak-AV, GDT MINI-II, GDT MINI-IV, GDT MINI-III, GDT Prizm, GDT Prizm-2 and MDT GEM-I series
  2. Epicardial lead or subcutaneous array
  3. Device has reached elective replacement indicator (ERI) or end of life (EOL)
  4. Other usual contraindications to MRI scanning
  5. Known or suspected lead fracture or abandoned lead
  6. Pacemaker dependent patients with an ICD that cannot be programmed to asynchronous pacing (DOO/VOO)
  7. Clinical factors that are deemed by the PI or Sub-I to increase the participant's risk above an acceptable clinical threshold
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01999751

Contacts
Contact: Micheal E Mollerus, MD 218-786-3443 michael.mollerus@essentiahealth.org

Locations
United States, Minnesota
St. Mary's Medical Center Recruiting
Duluth, Minnesota, United States, 55812
Contact: Michael E Mollerus, MD    218-786-3443    michael.mollerus@essentiahealth.org   
Principal Investigator: Michael E Mollerus, MD         
Sponsors and Collaborators
Essentia Health
Investigators
Principal Investigator: Michael E Mollerus, MD Essentia Health
  More Information

Publications:

Responsible Party: Michael Mollerus, Physician, Essentia Health
ClinicalTrials.gov Identifier: NCT01999751     History of Changes
Other Study ID Numbers: EH12274
Study First Received: November 26, 2013
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Essentia Health:
Magnetic Resonance Imaging
Pacemaker, Artificial
Defibrillators, Implantable

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014