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NCT00395447 · ClinicalTrials.gov registry record
REPLACE: Implantable Cardiac Pulse Generator Replacement Registry
A clinical trial of Postoperative Complications and Device Replacement, sponsored by Biotronik.
- Completed
- Registry status
- 1,744
- Enrollment target
- 20
- Study locations
NCT00395447: Completed study of Postoperative Complications and Device Replacement, sponsored by Biotronik.
NCT00395447 is a study of Postoperative Complications and Device Replacement that has completed, run by Biotronik. The registered enrollment target is 1,744 participants, above the 475-participant average among 20 other Postoperative Complications trials with a reported enrollment target (267% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00395447, a study of Postoperative Complications and Device Replacement, has completed, sponsored by Biotronik.
- COMPLETED
- Registry status
- 1,744 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The percentage of subjects experiencing one of the pre-defined complications is presented. The percentage of subjects experincing a complication is presented separately for subjects with a straight-forward device replacment (generator replacement procedure plan did not include a lead addition or revision) and subjects with a planned system modification (generator replacement procedure plan did include a lead addition or revision).
Conditions Studied
Interventions
- PROCEDURE Straight-forward Device Replacement
- PROCEDURE Device Replacement with Upgrade
Study Locations (20)
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
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
Georgia
- Piedmont Hospital - Atlanta
- Emory University Clinic - Atlanta
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Mesa Cardiovascular - Mesa
District of Columbia
- George Washington University - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,744 participants |
| Start Date | 2007-07 |
| Est. Completion | 2009-06 |
What the finished NCT00395447 record still lists
NCT00395447 is an observational study that tracks outcomes without assigning an intervention. Its 1,744 participants enrollment target places it among the larger protocols in the corpus, above the 475-participant average among 20 other Postoperative Complications trials with a reported enrollment target (267% higher).
The record links to 5 conditions, with Postoperative Complications appearing as the primary indexed condition, and to 2 interventions - of which Straight-forward Device Replacement is the first listed.
NCT00395447 names 20 study sites across 7 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT00395447 about?
NCT00395447 is a clinical study titled "REPLACE: Implantable Cardiac Pulse Generator Replacement Registry". 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. Secondari...
What is the current status of trial NCT00395447?
This trial is currently completed. The enrollment target is 1,744 participants. The study started on 2007-07. Estimated completion is 2009-06.
What conditions does trial NCT00395447 study?
This clinical trial studies the following conditions: Postoperative Complications, Device Replacement, Elective Replacement (ERI), Device Advisory, Device Upgrade.
What interventions are being tested in trial NCT00395447?
The interventions under investigation include: Straight-forward Device Replacement (PROCEDURE), Device Replacement with Upgrade (PROCEDURE).
Who is sponsoring clinical trial NCT00395447?
This trial is sponsored by Biotronik, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00395447 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00395447's enrollment target sits among peer trials
1,744 3rd of 20 higher than 18 of 20 other Postoperative Complications trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Complications trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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