NCT00806377

Brief Summary

The purpose of this study is:

  • To document the incidence of electromagnetic oversensing of ICDs during non-thoracic surgery.
  • To identify any non-thoracic procedure with a higher incidence of generating electromagnetic oversensing.
  • To document the ability of dual chamber ICDs to discriminate electromagnetic oversensing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

2.8 years

First QC Date

December 9, 2008

Last Update Submit

May 30, 2017

Conditions

Implantable Cardioverter-Defibrillators

Keywords

Electromagnetic fieldOversensingNon-thoracic surgery

Outcome Measures

Primary Outcomes (1)

  • Electromagnetic oversensing will be reported as a percentage of the total enrolled patients

    Assessed at time of procedure

Secondary Outcomes (2)

  • Non-thoracic procedures with a higher incidence of generating electromagnetic oversensing

    Assessed at time of procedure

  • Incidence of dual chamber ICDs discriminating electromagnetic oversensing.

    At time of procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing elective, non-thoracic surgical procedures will be enrolled.

You may qualify if:

  • Patients with Medtronic or Boston Scientific single and dual chamber ICDs

You may not qualify if:

  • Non-thoracic ICD generator placement (abdominal)
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Related Publications (2)

  • Fiek M, Dorwarth U, Durchlaub I, Janko S, Von Bary C, Steinbeck G, Hoffmann E. Application of radiofrequency energy in surgical and interventional procedures: are there interactions with ICDs? Pacing Clin Electrophysiol. 2004 Mar;27(3):293-8. doi: 10.1111/j.1540-8159.2004.00430.x.

    PMID: 15009852BACKGROUND

  • Hauser RG, Kallinen L. Deaths associated with implantable cardioverter defibrillator failure and deactivation reported in the United States Food and Drug Administration Manufacturer and User Facility Device Experience Database. Heart Rhythm. 2004 Oct;1(4):399-405. doi: 10.1016/j.hrthm.2004.05.006.

    PMID: 15851191BACKGROUND

Study Officials

  • William T Katsyiannis, MD

    Minneapolis Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2008

First Posted

December 10, 2008

Study Start

December 1, 2008

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

US(1)