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REPLACE: Implantable Cardiac Pulse Generator Replacement Registry (REPLACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00395447
Recruitment Status : Completed
First Posted : November 3, 2006
Results First Posted : November 30, 2010
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Device Replacement Elective Replacement (ERI) Device Advisory Device Upgrade Postoperative Complications Procedure: Straight-forward Device Replacement Procedure: Device Replacement with Upgrade

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 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.

Study Design
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Study Type : Observational
Actual Enrollment : 1744 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Assessment of the Complication Rate After Device Replacement Due to ERI, Advisory or Upgrade
Study Start Date : July 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009
Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with device replacement procedures at study sites
Criteria

Inclusion Criteria:

  • Is able to give informed consent
  • Is identified for generator replacement without system modification or generator replacement including planned system modification, regardless of generator manufacturer
  • Is clinically stable to tolerate the surgical procedure
  • Age 18 years or greater
  • Is geographically stable and able to return to the investigational site for follow-up care through the six-month visit

Exclusion Criteria:

  • Inability or unwillingness to give informed consent
  • Current system infection requiring generator explantation or lead extraction
  • Generator replacement requiring planned lead extraction
  • Participating in another cardiovascular investigational drug or device registry
  • A life expectancy of less than six months
  • Expected to receive a heart transplant within 6 months
  • All vulnerable subjects as defined by the FDA Office of Human Research Protection or the local IRB providing oversight
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00395447


Locations
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Sponsors and Collaborators
Biotronik, Inc.
Investigators
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Principal Investigator: Jeanne Poole, MD University of Washington
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT00395447    
Other Study ID Numbers: REPLACE
First Posted: November 3, 2006    Key Record Dates
Results First Posted: November 30, 2010
Last Update Posted: April 14, 2015
Last Verified: March 2015
Keywords provided by Biotronik, Inc.:
Cardiac Pacemaker
Defibrillator
Replacement
Upgrade
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes