REPLACE: Implantable Cardiac Pulse Generator Replacement Registry

Completed

• Conditions: Device Replacement; Device Upgrade; Elective Replacement (ERI); Postoperative Complications; Device Advisory

• Registration Number: NCT00395447
• Lead Sponsor: Biotronik, Inc.

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 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 Timeline

• Study First Submitted: 2006-11-01
• Study First Submitted QC: 2006-11-02
• Study First Posted: 2006-11-03
• Study Start: 2007-07
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2010-08-24
• Results First Submitted QC: 2010-11-01
• Results First Posted: 2010-11-30
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1744

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	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).

Trial Locations

Locations (71)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Mesa Cardiovascular; 🇺🇸 Mesa, Arizona, United States

Stanislaus Cardiology; 🇺🇸 Modesto, California, United States

Desert Cardiology; 🇺🇸 Rancho Mirage, California, United States

Mercy General Hospital; 🇺🇸 Sacramento, California, United States

UCSD Medical Center; 🇺🇸 San Diego, California, United States

UCSF; 🇺🇸 San Francisco, California, United States

Penrose Hospital; 🇺🇸 Colorado Springs, Colorado, United States

Aurora Denver Cardiology; 🇺🇸 Denver, Colorado, United States

George Washington University; 🇺🇸 Washington, District of Columbia, United States

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