NCT00395447
REPLACE: Implantable Cardiac Pulse Generator Replacement Registry
COMPLETED
NCT00395447
OBSERVATIONAL
Prospective Assessment of the Complication Rate After Device Replacement Due to ERI, Advisory or Upgrade
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.
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
Device Replacement
Elective Replacement (ERI)
Device Advisory
Device Upgrade
Postoperative Complications
-
- Type: PROCEDURE
- Name: Straight-forward Device Replacement
- Description:
- Arm Group Labels: Straight-forward Device Replacement
-
- Type: PROCEDURE
- Name: Device Replacement with Upgrade
- Description:
- Arm Group Labels: Device Replacement with Upgrade
- Biotronik, Inc.