NCT01169441

Brief Summary

The recent expansion of indications for implantable cardioverter defibrillators (ICDs) has changed the population of patients being implanted. Younger and healthier patients are now being implanted for primary prevention of sudden cardiac death. Due to the younger population, the likelihood of the lead failing during the lifetime of the patient is higher and also more likely to need extraction. To reduce the risk of the lead extraction procedure and therefore reduce the number of abandon leads, ICD lead manufacturers are designing leads to offer improved chronic extractability to reduce the morbidity and mortality during these procedures.

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 Nov 2006

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

November 1, 2006

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 26, 2010

Completed
Last Updated

July 26, 2010

Status Verified

May 1, 2009

Enrollment Period

3.3 years

First QC Date

May 28, 2009

Last Update Submit

July 23, 2010

Conditions

Cardiac Surgical Procedures

Keywords

ICD leadsRemovalExtractionVentricular leadsExtractlaserObserve the lead with x-ray during movement and collect information on current ways of removing an ICD lead.

Eligibility Criteria

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

Subjects who are scheduled for an ICD lead extraction

You may qualify if:

  • Subjects must be 18 years of age or older,
  • be scheduled for an ICD lead extraction and
  • willing and able to sign the informed consent.

You may not qualify if:

  • Patients with lead implant duration less than 6 months,
  • patients with gross chronic lead infections,
  • patients with epicardial or subcutaneous ICD systems (without transvenous ICD lead) and
  • patients who are pregnant or suspect they may be pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Paul Heart Clinic

Saint Paul, Minnesota, 55102, United States

Location

Study Officials

  • Pierce J. Vatterott, M.D.

    St. Paul Heart Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2009

First Posted

July 26, 2010

Study Start

November 1, 2006

Primary Completion

March 1, 2010

Study Completion

May 1, 2010

Last Updated

July 26, 2010

Record last verified: 2009-05

Locations

US(1)