REPLACE: Implantable Cardiac Pulse Generator Replacement Registry

Postoperative Complications Clinical Trial

— REPLACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395447
• Other study ID #: REPLACE
• Status: Completed
• Phase: Phase 4
• First received: November 1, 2006
• Last updated: March 24, 2015
• Start date: July 2007
• Est. completion date: June 2009

Study information

• Verified date: March 2015
• Source: Biotronik, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1744
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Device Advisory
• Device Replacement
• Device Upgrade
• Elective Replacement (ERI)
• Postoperative Complications

Intervention

Procedure:
• Straight-forward Device Replacement

• Device Replacement with Upgrade

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No