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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 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 284-participant average among 17 other Postoperative Complications trials with a reported enrollment target (514% higher). The trial reports 20 study locations across 7 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00395447
The ClinicalTrials.gov registry entry for NCT00395447 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,744 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 284-participant average among 17 other Postoperative Complications trials with a reported enrollment target (514% higher). The listed sponsor is Biotronik, which has 30 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.