REPLACE: Implantable Cardiac Pulse Generator Replacement Registry

Completed

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

Interventions: Procedure: Device Replacement with Upgrade
Procedure: Straight-forward Device Replacement

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.

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

Arm && Interventions

Group	Intervention	Description
Device Replacement with Upgrade	Device Replacement with Upgrade	Subjects with a device replacement and planned lead upgrade, revision, or addition.
Straight-forward Device Replacement	Straight-forward Device Replacement	Subject with a straight-forward device replacement without lead revisions or additions.

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).

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (71): Mesa Cardiovascular
🇺🇸
Mesa, Arizona, United States
Desert Cardiology
🇺🇸
Rancho Mirage, California, United States
Midatlantic Cardiovascular Associates
🇺🇸
Baltimore, Maryland, United States
The University of Chicago
🇺🇸
Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
University Hospitals Cleveland
🇺🇸
Cleveland, Ohio, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Bayfront Medical Center
🇺🇸
St. Petersburg, Florida, United States
Mt. Sinai Medical Center
🇺🇸
Miami Beach, Florida, United States
Wuesthoff Hospital
🇺🇸
Rockledge, Florida, United States
Loyola University
🇺🇸
Maywood, Illinois, United States
Piedmont Hospital
🇺🇸
Atlanta, Georgia, United States
Louisiana Heart
🇺🇸
Lafayette, Louisiana, United States
University of Kansas Hospital
🇺🇸
Kansas City, Kansas, United States
University of Maryland
🇺🇸
Baltimore, Maryland, United States
Central Baptist
🇺🇸
Lexington, Kentucky, United States
Mid America Heart
🇺🇸
Kansas City, Missouri, United States
Shady Grove Adventist
🇺🇸
Rockville, Maryland, United States
New England Cardiovascular Specialists
🇺🇸
Boston, Massachusetts, United States
Lahey Clinic
🇺🇸
Burlington, Massachusetts, United States
St. Joseph Mercy Hospital
🇺🇸
Ypsilanti, Michigan, United States
North Shore Medical Center
🇺🇸
Salem, Massachusetts, United States
Forrest General Hospital
🇺🇸
Hattiesburg, Mississippi, United States
St. Luke's Roosevelt Hospital
🇺🇸
New York, New York, United States
Barnes Jewish Hospital
🇺🇸
St. Louis, Missouri, United States
Buffalo Heart Group
🇺🇸
Buffalo, New York, United States
St. Barnabas
🇺🇸
West Orange, New Jersey, United States
Heart and Vascular Center, MetroHealth MC
🇺🇸
Cleveland, Ohio, United States
Abington Medical Specialists
🇺🇸
Abington, Pennsylvania, United States
Hillcrest Medical Center
🇺🇸
Tulsa, Oklahoma, United States
Christus Spohn
🇺🇸
Corpus Christi, Texas, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
South Carolina Heart Center
🇺🇸
Columbia, South Carolina, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Pee Dee Cardiology
🇺🇸
Florence, South Carolina, United States
Sentara Norfolk General Hospital
🇺🇸
Norfolk, Virginia, United States
CAMC Memorial Hospital
🇺🇸
Charleston, West Virginia, United States
University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
OU Medical Center Presbyterian
🇺🇸
Oklahoma City, Oklahoma, United States
Oregon Health Sciences University
🇺🇸
Portland, Oregon, United States
UCSD Medical Center
🇺🇸
San Diego, California, United States
UCSF
🇺🇸
San Francisco, California, United States
Aurora Denver Cardiology
🇺🇸
Denver, Colorado, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
University of Cincinnati
🇺🇸
Cincinnati, Ohio, United States
Vanderbilt University
🇺🇸
Nashville, Tennessee, United States
Creighton University
🇺🇸
Omaha, Nebraska, United States
Heart Consultants Omaha
🇺🇸
Omaha, Nebraska, United States
Alegent Hospitals
🇺🇸
Omaha, Nebraska, United States
UT Southwestern
🇺🇸
Dallas, Texas, United States
Spartanburg Regional Medical Center
🇺🇸
Spartanburg, South Carolina, United States
Mercy General Hospital
🇺🇸
Sacramento, California, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
Forsyth Medical Center
🇺🇸
Winston-Salem, North Carolina, United States
Stanislaus Cardiology
🇺🇸
Modesto, California, United States
George Washington University
🇺🇸
Washington, District of Columbia, United States
Halifax Medical Center
🇺🇸
Daytona Beach, Florida, United States
Penrose Hospital
🇺🇸
Colorado Springs, Colorado, United States
Manatee Memorial
🇺🇸
Bradenton, Florida, United States
Emory University Clinic
🇺🇸
Atlanta, Georgia, United States
Baptist Jacksonville
🇺🇸
Jacksonville Beach, Florida, United States
Florida Medical Center
🇺🇸
Zephyrhills, Florida, United States
Tufts University
🇺🇸
Boston, Massachusetts, United States
Tulane University
🇺🇸
New Orleans, Louisiana, United States
Union Memorial Hospital
🇺🇸
Baltimore, Maryland, United States
Sacred Heart Medical Center
🇺🇸
Eugene, Oregon, United States
Amarillo Heart
🇺🇸
Amarillo, Texas, United States
Heart Center of North Texas
🇺🇸
Fort Worth, Texas, United States
University of South Florida
🇺🇸
Tampa, Florida, United States
University of Washington
🇺🇸
Seattle, Washington, United States
Thomas Jefferson University
🇺🇸
Philadelphia, Pennsylvania, United States