REPLACE: Implantable Cardiac Pulse Generator Replacement Registry

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.
ClinicalTrials.gov Identifier:
NCT00395447
First received: November 1, 2006
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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
Device Replacement
Elective Replacement (ERI)
Device Advisory
Device Upgrade
Postoperative Complications
Procedure: Straight-forward Device Replacement
Procedure: Device Replacement with Upgrade
Phase 4

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Biotronik, Inc.:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 1744
Study Start Date: July 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395447

  Show 71 Study Locations
Sponsors and Collaborators
Biotronik, Inc.
Investigators
Principal Investigator: Jeanne Poole, MD University of Washington
  More Information

No publications provided by Biotronik, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT00395447     History of Changes
Other Study ID Numbers: REPLACE
Study First Received: November 1, 2006
Results First Received: August 24, 2010
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Biotronik, Inc.:
Cardiac Pacemaker
Defibrillator
Replacement
Upgrade

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014