NCT00356330

Brief Summary

To evaluate short-term and long-term effects by MR imaging at 3T on the technical and functional status of cardiac pacemakers.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2006

Completed
Last Updated

April 11, 2007

Status Verified

April 1, 2007

First QC Date

July 25, 2006

Last Update Submit

April 9, 2007

Conditions

Heart Diseases

Keywords

pacemakermagnetic resonance imagingsafety

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Urgent need for an MRI examination
  • Stable pacemaker physical parameters
  • Battery voltage \> 2.7 V
  • Battery impedance \< 2000 Ohm
  • Battery estimated remaining lifetime \> 6 months
  • Lead impedances 200-2000 Ohm
  • Stable pacing parameters
  • Pacing capture threshold \<2.5V at a pulse duration of 0.4ms
  • Sensing \> 5mV
  • Minimum 3 months since pacemaker and lead implantation

You may not qualify if:

  • History of ventricular tachycardia (VT) or ventricular fibrillation
  • Unstable angina
  • Myocardial infarction within the previous 3 months
  • Cardiothoracic surgery within the previous 3 months
  • Presence of an abdominal pacemaker with lead length \> 70 cm
  • Presence of MRI incompatible bioimplants or other MRI incompatible materials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bonn, Department of Radiology

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Torsten Sommer, MD

    University of Bonn, Department of Radiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Torsten Sommer, MD

CONTACT

+49-163-6113875t.sommer@uni-bonn.de

Claas P Naehle, MD

CONTACT

+49-178-4001619cp@naehle.net

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 25, 2006

First Posted

July 26, 2006

Last Updated

April 11, 2007

Record last verified: 2007-04

Locations

DE(1)