Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00395447
Status:
COMPLETED
Last Update Posted:
2015-04-14
First Post:
2006-11-01
Brief Title:
REPLACE Implantable Cardiac Pulse Generator Replacement Registry
Sponsor:
Biotronik Inc
Organization:
Biotronik Inc
Study Overview
Official Title:
Prospective Assessment of the Complication Rate After Device Replacement Due to ERI Advisory or Upgrade
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPLACE
Brief Summary:
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
Detailed Description:
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 183 replacement rate and subsequent 81 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
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 183 replacement rate and subsequent 81 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None