REPLACE: Implantable Cardiac Pulse Generator Replacement Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Assessment of the Complication Rate After Device Replacement Due to ERI, Advisory or Upgrade

Conditions
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Device Replacement, Elective Replacement (ERI), Device Advisory, Device Upgrade, Postoperative Complications

Intervention / Treatment
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* Procedure: Straight-forward Device Replacement
* Procedure: Device Replacement with Upgrade


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Straight-forward Device Replacement<br>Subject with a straight-forward device replacement without lead revisions or additions. | Procedure: Straight-forward Device Replacement<br> <br> |
| Device Replacement with Upgrade<br>Subjects with a device replacement and planned lead upgrade, revision, or addition. | Procedure: Device Replacement with Upgrade<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Pacemaker, Defibrillator, Replacement, Upgrade