NCT00599261

Brief Summary

To determine the effect of scar tissue removal on the rate of infection and any other complications such as bleeding in patients with an ICD or pacemaker who have the device generator or leads replaced or repositioned.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
265

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_4

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

January 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 23, 2008

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 10, 2013

Status Verified

January 1, 2013

Enrollment Period

4.9 years

First QC Date

January 11, 2008

Last Update Submit

January 8, 2013

Conditions

Infection

Keywords

Cardiac Pacemaker, Artificial

Outcome Measures

Primary Outcomes (1)

  • Oral temperature, edema/redness/drainage and/or severity of pain at incision site, presence of chills, reported fever

    1 year

Secondary Outcomes (1)

  • If primary outcome measures are positive, blood and/or device cultures and lab work may be obtained

    1 year

Study Arms (2)

1

EXPERIMENTAL

Removal of the fibrotic pocket surrounding the generator and leads

Procedure: ICD/pacemaker pocket revision

2

EXPERIMENTAL

Tissue is not removed

Procedure: ICD/pacemaker pocket revision

Interventions

ICD/pacemaker pocket revisionPROCEDURE

Pocket revision consists of complete removal of the fibrous capsule surrounding the device and leads

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or greater
  • Willingness to provide written informed consent
  • Subjects presenting for any of the following:
  • pacemaker/ICD generator change
  • pacemaker/ICD lead replacement
  • pacemaker/ICD lead revision
  • pacemaker/ICD upgrades

You may not qualify if:

  • Age less than 18 years
  • Unwillingness to provide written informed consent
  • Subjects unable to give consent
  • Pregnant or nursing women
  • Patients who have undergone pocket revision or manipulation less than 365 days prior
  • Patients who have undergone pacemaker or ICD implantation less than 365 days prior

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

  • Lakkireddy D, Pillarisetti J, Atkins D, Biria M, Reddy M, Murray C, Bommana S, Shanberg D, Adabala N, Pimentel R, Dendi R, Emert M, Vacek J, Dawn B, Berenbom L. IMpact of pocKet rEvision on the rate of InfecTion and other CompLications in patients rEquiring pocket mAnipulation for generator replacement and/or lead replacement or revisioN (MAKE IT CLEAN): A prospective randomized study. Heart Rhythm. 2015 May;12(5):950-6. doi: 10.1016/j.hrthm.2015.01.035. Epub 2015 Jan 24.

    PMID: 25625720DERIVED

MeSH Terms

Conditions

Infections

Study Officials

  • Dhanunjaya Lakkireddy, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

January 11, 2008

First Posted

January 23, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 10, 2013

Record last verified: 2013-01

Locations

US(1)