REPLACE: Implantable Cardiac Pulse Generator Replacement Registry
The objective of this study is to prospectively estimate the all-cause complication rates at 6-months for patients undergoing generator replacement due to elective replacement indicator (ERI), advisory, or upgrade without a planned system modification or with a planned system modification. Secondarily, this study aims to compare the influence of baseline variables contributing to the all-cause complication rates for subjects undergoing generator replacement.
Elective Replacement (ERI)
Procedure: Straight-forward Device Replacement
Procedure: Device Replacement with Upgrade
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospective Assessment of the Complication Rate After Device Replacement Due to ERI, Advisory or Upgrade|
- Percentage of Subjects Experiencing a Complication During Generator Replacement Without a Planned Lead Revision or Addition (Straight-forward Device Replacment) or With a Planned Lead Revision or Addition (Planned System Modification) [ Time Frame: 6 months ] [ Designated as safety issue: No ]The percentage of subjects experiencing one of the pre-defined complications is presented. The percentage of subjects experincing a complication is presented separately for subjects with a straight-forward device replacment (generator replacement procedure plan did not include a lead addition or revision) and subjects with a planned system modification (generator replacement procedure plan did include a lead addition or revision).
- Baseline Variables for Subjects Undergoing Generator Replacement Without a Planned Lead Revision or Addition (Straight-forward Device Replacment) or With a Planned Lead Revision or Addition (Planned System Modification) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Straight-forward Device Replacement
Subject with a straight-forward device replacement without lead revisions or additions.
|Procedure: Straight-forward Device Replacement|
Device Replacement with Upgrade
Subjects with a device replacement and planned lead upgrade, revision, or addition.
|Procedure: Device Replacement with Upgrade|
Device replacements occur for many reasons, including elective replacement indication (ERI), manufacturer advisory, and upgrade.
Recently pacemaker and implantable cardioverter (ICD) advisories have created a dilemma for both physicians and patients. While the risk of device malfunction is low, replacement rates following an advisory are usually high and complication rates following device replacement are not widely known. One retrospective analysis of ICD advisories in Canada reported an 18.3% replacement rate, and subsequent 8.1% complication rate directly related to the replacement.
Device replacements also occur in order to upgrade an existing system. Clinical studies have shown that cardiac resynchronization therapy (CRT) significantly reduces all-cause mortality and hospitalization in patients with advanced heart failure (HF). As a result of expanding indications for this therapy, many standard ICD patients are being upgraded to CRT-D systems. Complication rates related to upgrades of these systems are also not widely known.
To our knowledge, the risk of complications following a device replacement has not been studied prospectively in any patient population. Limited data are available to guide physicians when weighing the risks and benefits of device replacement.
This is a prospective multi-center study. 1750 patients at 100 clinical sites will be enrolled prior to generator replacement. Patients will be implanted and followed for 6 months to assess any complications related to the replacement procedure.
Patients with any legally marketed device for explant can be enrolled. The replacement device can be from any manufacturer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00395447
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|Principal Investigator:||Jeanne Poole, MD||University of Washington|