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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00395447
Other study ID # REPLACE
Secondary ID
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


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
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