N/A
N=1,744
REPLACE: Implantable Cardiac Pulse Generator Replacement Registry
Device Replacement · Elective Replacement (ERI) · Device Advisory · Device Upgrade · Postoperative Complications
Bottom Line
View on ClinicalTrials.gov: NCT00395447 ↗Enrolled (actual)
1,744
Serious AEs
0.0%
Results posted
Nov 2010
Primary outcome: 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) — 10.8; 20.9 Percentage of participants (%)
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Straight-forward Device Replacement (Procedure); Device Replacement with Upgrade (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biotronik, Inc.
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
10.8; 20.9 | — |
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 Criteria
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
Data sourced from ClinicalTrials.gov (NCT00395447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.