Postoperative Complications Clinical Trial
Official title:
Prospective Assessment of the Complication Rate After Device Replacement Due to ERI, Advisory or Upgrade
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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