REPLACE: Implantable Cardiac Pulse Generator Replacement Registry

Biotronik

Status

Completed

Conditions

Postoperative Complications

Elective Replacement (ERI)

Device Replacement

Device Upgrade

Device Advisory

Treatments

Procedure: Straight-forward Device Replacement

Procedure: Device Replacement with Upgrade

Study type

Observational

Funder types

Industry

Identifiers

NCT00395447

REPLACE

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,744 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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