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Sponsored by: |
Biotronik, Inc. |
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Information provided by: | Biotronik, Inc. |
ClinicalTrials.gov Identifier: | NCT00395447 |
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.
Condition | Intervention | Phase |
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Device Replacement Elective Replacement (ERI) Device Advisory Device Upgrade Postoperative Complications |
Procedure: Pulse generator replacement or upgrade Device: Pacemaker, ICD or CRT system |
Phase IV |
Study Type: | Interventional |
Study Design: | Health Services Research, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Prospective Assessment of the Complication Rate After Device Replacement Due to ERI, Advisory or Upgrade |
Estimated Enrollment: | 1750 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Jeanne Poole, MD | University of Washington |
Responsible Party: | BIOTRONIK, Inc. ( Katerina deMetz ) |
Study ID Numbers: | REPLACE |
Study First Received: | November 1, 2006 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00395447 History of Changes |
Health Authority: | United States: Institutional Review Board |
Cardiac Pacemaker Defibrillator Replacement Upgrade |
Postoperative Complications |
Pathologic Processes Postoperative Complications |