Status:
COMPLETED
REPLACE: Implantable Cardiac Pulse Generator Replacement Registry
Lead Sponsor:
Biotronik, Inc.
Conditions:
Device Replacement
Elective Replacement (ERI)
Eligibility:
All Genders
18+ years
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), advisor...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
1744 Patients enrolled
Trial Details
Trial ID
NCT00395447
Start Date
July 1 2007
End Date
June 1 2009
Last Update
April 14 2015
Active Locations (71)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Mesa Cardiovascular
Mesa, Arizona, United States, 85206
3
Stanislaus Cardiology
Modesto, California, United States, 95355
4
Desert Cardiology
Rancho Mirage, California, United States, 92270