Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This is a randomized, prospective, single-blind study that evaluates the effect of removal of scar tissue during pacemaker/ICD pocket revision on infection and complications. Subjects will be randomly assigned to either removal of the scar tissue surrounding the implanted device during device replacement or to device replacement without removal of this tissue. Subjects will be followed for one year post-procedure for the occurrence of infection, bleeding/hematoma, or other complications.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Removal of the fibrotic pocket surrounding the generator and leads |
|
| 2 | Experimental | Tissue is not removed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICD/pacemaker pocket revision | Procedure | Pocket revision consists of complete removal of the fibrous capsule surrounding the device and leads |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oral temperature, edema/redness/drainage and/or severity of pain at incision site, presence of chills, reported fever | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| If primary outcome measures are positive, blood and/or device cultures and lab work may be obtained | 1 year |
Not provided
Inclusion Criteria:
Age 18 years or greater
Willingness to provide written informed consent
Subjects presenting for any of the following:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dhanunjaya Lakkireddy, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Hospital | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25625720 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
Not provided