REPLACE: Implantable Cardiac Pulse Generator Replacement Registry

Completed

Conditions studied: Device Replacement, Elective Replacement (ERI), Device Advisory, Device Upgrade, Postoperative Complications

In brief

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.

Key facts

Study ID

NCT00395447

Run by

Biotronik, Inc.

People needed

1744

Starts

2007-07-01

Expected to finish

2009-06-01

Last updated by the study team

2015-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.