REPLACE: Implantable Cardiac Pulse Generator Replacement Registry
NCT ID: NCT00395447
Last Updated: 2015-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
1744 participants
OBSERVATIONAL
2007-07-31
2009-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Straight-forward Device Replacement
Subject with a straight-forward device replacement without lead revisions or additions.
Straight-forward Device Replacement
Device Replacement with Upgrade
Subjects with a device replacement and planned lead upgrade, revision, or addition.
Device Replacement with Upgrade
Interventions
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Straight-forward Device Replacement
Device Replacement with Upgrade
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Biotronik, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jeanne Poole, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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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 D.C., District of Columbia, United States
Manatee Memorial
Bradenton, Florida, United States
Halifax Medical Center
Daytona Beach, Florida, United States
Baptist Jacksonville
Jacksonville Beach, Florida, United States
Mt. Sinai Medical Center
Miami Beach, Florida, United States
Wuesthoff Hospital
Rockledge, Florida, United States
Bayfront Medical Center
St. Petersburg, Florida, United States
University of South Florida
Tampa, Florida, United States
Florida Medical Center
Zephyrhills, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
Emory University Clinic
Atlanta, Georgia, United States
The University of Chicago
Chicago, Illinois, United States
Loyola University
Maywood, Illinois, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Central Baptist
Lexington, Kentucky, United States
Louisiana Heart
Lafayette, Louisiana, United States
Tulane University
New Orleans, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
Midatlantic Cardiovascular Associates
Baltimore, Maryland, United States
Union Memorial Hospital
Baltimore, Maryland, United States
Shady Grove Adventist
Rockville, Maryland, United States
Tufts University
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
New England Cardiovascular Specialists
Boston, Massachusetts, United States
Lahey Clinic
Burlington, Massachusetts, United States
North Shore Medical Center
Salem, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
St. Joseph Mercy Hospital
Ypsilanti, Michigan, United States
Forrest General Hospital
Hattiesburg, Mississippi, United States
Mid America Heart
Kansas City, Missouri, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Heart Consultants Omaha
Omaha, Nebraska, United States
Alegent Hospitals
Omaha, Nebraska, United States
Creighton University
Omaha, Nebraska, United States
St. Barnabas
West Orange, New Jersey, United States
Buffalo Heart Group
Buffalo, New York, United States
St. Luke's Roosevelt Hospital
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Forsyth Medical Center
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
University Hospitals Cleveland
Cleveland, Ohio, United States
Heart and Vascular Center, MetroHealth MC
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
OU Medical Center Presbyterian
Oklahoma City, Oklahoma, United States
Hillcrest Medical Center
Tulsa, Oklahoma, United States
Sacred Heart Medical Center
Eugene, Oregon, United States
Oregon Health Sciences University
Portland, Oregon, United States
Abington Medical Specialists
Abington, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
South Carolina Heart Center
Columbia, South Carolina, United States
Pee Dee Cardiology
Florence, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
Amarillo Heart
Amarillo, Texas, United States
Christus Spohn
Corpus Christi, Texas, United States
UT Southwestern
Dallas, Texas, United States
Heart Center of North Texas
Fort Worth, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
University of Washington
Seattle, Washington, United States
CAMC Memorial Hospital
Charleston, West Virginia, United States
Countries
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References
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Chung MK, Holcomb RG, Mittal S, Steinberg JS, Gleva MJ, Mela T, Uslan DZ, Mitchell K, Poole JE; REPLACE Investigators. REPLACE DARE (Death After Replacement Evaluation) score: determinants of all-cause mortality after implantable device replacement or upgrade from the REPLACE registry. Circ Arrhythm Electrophysiol. 2014 Dec;7(6):1048-56. doi: 10.1161/CIRCEP.114.001671. Epub 2014 Sep 14.
Uslan DZ, Gleva MJ, Warren DK, Mela T, Chung MK, Gottipaty V, Borge R, Dan D, Shinn T, Mitchell K, Holcomb RG, Poole JE. Cardiovascular implantable electronic device replacement infections and prevention: results from the REPLACE Registry. Pacing Clin Electrophysiol. 2012 Jan;35(1):81-7. doi: 10.1111/j.1540-8159.2011.03257.x. Epub 2011 Nov 11.
Poole JE, Gleva MJ, Mela T, Chung MK, Uslan DZ, Borge R, Gottipaty V, Shinn T, Dan D, Feldman LA, Seide H, Winston SA, Gallagher JJ, Langberg JJ, Mitchell K, Holcomb R; REPLACE Registry Investigators. Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation. 2010 Oct 19;122(16):1553-61. doi: 10.1161/CIRCULATIONAHA.110.976076. Epub 2010 Oct 4.
Other Identifiers
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REPLACE
Identifier Type: -
Identifier Source: org_study_id
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