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

Status: Completed
Location: See all (71) locations...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
Arizona
Mesa Cardiovascular
Mesa
California
Stanislaus Cardiology
Modesto
Desert Cardiology
Rancho Mirage
Mercy General Hospital
Sacramento
UCSD Medical Center
San Diego
UCSF
San Francisco
Colorado
Penrose Hospital
Colorado Springs
Aurora Denver Cardiology
Denver
Washington, D.c.
George Washington University
Washington
Florida
Manatee Memorial
Bradenton
Halifax Medical Center
Daytona Beach
Baptist Jacksonville
Jacksonville Beach
Mt. Sinai Medical Center
Miami Beach
Wuesthoff Hospital
Rockledge
Bayfront Medical Center
St. Petersburg
University of South Florida
Tampa
Florida Medical Center
Zephyrhills
Georgia
Emory University Clinic
Atlanta
Piedmont Hospital
Atlanta
Illinois
The University of Chicago
Chicago
Loyola University
Maywood
Kansas
University of Kansas Hospital
Kansas City
Kentucky
Central Baptist
Lexington
Louisiana
Louisiana Heart
Lafayette
Tulane University
New Orleans
Massachusetts
Massachusetts General Hospital
Boston
New England Cardiovascular Specialists
Boston
Tufts University
Boston
Lahey Clinic
Burlington
North Shore Medical Center
Salem
Maryland
Midatlantic Cardiovascular Associates
Baltimore
Union Memorial Hospital
Baltimore
University of Maryland
Baltimore
Shady Grove Adventist
Rockville
Michigan
University of Michigan
Ann Arbor
St. Joseph Mercy Hospital
Ypsilanti
Missouri
Mid America Heart
Kansas City
Barnes Jewish Hospital
St. Louis
Mississippi
Forrest General Hospital
Hattiesburg
North Carolina
Duke University Medical Center
Durham
Forsyth Medical Center
Winston-salem
Nebraska
Alegent Hospitals
Omaha
Creighton University
Omaha
Heart Consultants Omaha
Omaha
New Jersey
St. Barnabas
West Orange
New York
Buffalo Heart Group
Buffalo
St. Luke's Roosevelt Hospital
New York
Ohio
University of Cincinnati
Cincinnati
Cleveland Clinic
Cleveland
Heart and Vascular Center, MetroHealth MC
Cleveland
University Hospitals Cleveland
Cleveland
Oklahoma
OU Medical Center Presbyterian
Oklahoma City
Hillcrest Medical Center
Tulsa
Oregon
Sacred Heart Medical Center
Eugene
Oregon Health Sciences University
Portland
Pennsylvania
Abington Medical Specialists
Abington
Thomas Jefferson University
Philadelphia
University of Pennsylvania
Philadelphia
South Carolina
Medical University of South Carolina
Charleston
South Carolina Heart Center
Columbia
Pee Dee Cardiology
Florence
Spartanburg Regional Medical Center
Spartanburg
Tennessee
Vanderbilt University
Nashville
Texas
Amarillo Heart
Amarillo
Christus Spohn
Corpus Christi
UT Southwestern
Dallas
Heart Center of North Texas
Fort Worth
Virginia
Sentara Norfolk General Hospital
Norfolk
Washington
University of Washington
Seattle
West Virginia
CAMC Memorial Hospital
Charleston
Time Frame
Start Date: July 2007
Completion Date: June 2009
Participants
Target number of participants: 1744
Treatments
Straight-forward Device Replacement
Subject with a straight-forward device replacement without lead revisions or additions.
Device Replacement with Upgrade
Subjects with a device replacement and planned lead upgrade, revision, or addition.
Sponsors
Leads: Biotronik, Inc.

This content was sourced from clinicaltrials.gov

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