REPLACE: Implantable Cardiac Pulse Generator Replacement Registry - Full Text View

Sponsored by:	Biotronik, Inc.
Information provided by:	Biotronik, Inc.
ClinicalTrials.gov Identifier:	NCT00395447

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: Pulse generator replacement or upgrade Device: Pacemaker, ICD or CRT system	Phase IV

U.S. FDA Resources

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

Further study details as provided by Biotronik, Inc.:

Primary Outcome Measures:

Estimate the all-cause complication rate for undergoing generator replacement including a planned system modification [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Estimate the all-cause complication rate for undergoing generator replacement in patients receiving a "straight-forward" device replacement. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare baseline variables contributing to complication rate differences (e.g. age, co-morbidities) for subjects undergoing generator replacement without system modification [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Compare baseline variables contributing to complication rate differences (e.g. age, co-morbidities) for subjects undergoing generator replacement including a planned system modification [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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)

Intervention Details:

No protocol defined intervention

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

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

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

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
Health Authority:	United States: Institutional Review Board

Keywords provided by Biotronik, Inc.:

Cardiac Pacemaker
Defibrillator
Replacement
Upgrade

Study placed in the following topic categories:

Postoperative Complications

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009