Clinical trial NCT00395447: REPLACE: Implantable Cardiac Pulse Generator Replacement Registry
Official title: Prospective Assessment of the Complication Rate After Device Replacement Due to ERI, Advisory or Upgrade
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Device Replacement
Elective Replacement (ERI)
Device Advisory
Device Upgrade
Postoperative Complications
Keywords: Cardiac Pacemaker
Defibrillator
Replacement
Upgrade
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2006-11-03
Enrollment: 1744
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with device replacement procedures at study sites

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Mesa
country: United States
facility: Mesa Cardiovascular
state: Arizona
city: Modesto
country: United States
facility: Stanislaus Cardiology
state: California
city: Rancho Mirage
country: United States
facility: Desert Cardiology
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: Colorado Springs
country: United States
facility: Penrose Hospital
state: Colorado
city: Denver
country: United States
facility: Aurora Denver Cardiology
state: Colorado
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Bradenton
country: United States
facility: Manatee Memorial
state: Florida
city: Daytona Beach
country: United States
facility: Halifax Medical Center
state: Florida
city: Jacksonville Beach
country: United States
facility: Baptist Jacksonville
state: Florida
city: Miami Beach
country: United States
facility: Mt. Sinai Medical Center
state: Florida
city: Rockledge
country: United States
facility: Wuesthoff Hospital
state: Florida
city: St. Petersburg
country: United States
facility: Bayfront Medical Center
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Center
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Clinic
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Lexington
country: United States
facility: Central Baptist
state: Kentucky
city: Lafayette
country: United States
facility: Louisiana Heart
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Midatlantic Cardiovascular Associates
state: Maryland
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Rockville
country: United States
facility: Shady Grove Adventist
state: Maryland
city: Boston
country: United States
facility: Tufts University
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: New England Cardiovascular Specialists
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Salem
country: United States
facility: North Shore Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Ypsilanti
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Hattiesburg
country: United States
facility: Forrest General Hospital
state: Mississippi
city: Kansas City
country: United States
facility: Mid America Heart
state: Missouri
city: St. Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Omaha
country: United States
facility: Heart Consultants Omaha
state: Nebraska
city: Omaha
country: United States
facility: Alegent Hospitals
state: Nebraska
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: West Orange
country: United States
facility: St. Barnabas
state: New Jersey
city: Buffalo
country: United States
facility: Buffalo Heart Group
state: New York
city: New York
country: United States
facility: St. Luke's Roosevelt Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Heart and Vascular Center, MetroHealth MC
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: OU Medical Center Presbyterian
state: Oklahoma
city: Tulsa
country: United States
facility: Hillcrest Medical Center
state: Oklahoma
city: Eugene
country: United States
facility: Sacred Heart Medical Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Abington
country: United States
facility: Abington Medical Specialists
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Heart Center
state: South Carolina
city: Florence
country: United States
facility: Pee Dee Cardiology
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Heart
state: Texas
city: Corpus Christi
country: United States
facility: Christus Spohn
state: Texas
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Fort Worth
country: United States
facility: Heart Center of North Texas
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Charleston
country: United States
facility: CAMC Memorial Hospital
state: West Virginia
Study officials:
affiliation: University of Washington
name: Jeanne Poole, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.