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Completed No phase listed Observational Results available

REPLACE: Implantable Cardiac Pulse Generator Replacement Registry

ClinicalTrials.gov ID: NCT00395447

Public ClinicalTrials.gov record NCT00395447. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 3:29 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Prospective Assessment of the Complication Rate After Device Replacement Due to ERI, Advisory or Upgrade

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00395447
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Biotronik, Inc.
Industry
Enrollment
1,744 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2007 (Type not available)
Primary completion
Jun 2009 (Actual)
Completion
Jun 2009 (Actual)
Last update posted
Apr 14, 2015

2007 – 2009

United States locations

U.S. sites
71
U.S. states
30
U.S. cities
61
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294 —
Mesa Cardiovascular Mesa Arizona 85206 —
Stanislaus Cardiology Modesto California 95355 —
Desert Cardiology Rancho Mirage California 92270 —
Mercy General Hospital Sacramento California 95819 —
UCSD Medical Center San Diego California 92103 —
UCSF San Francisco California 94143 —
Penrose Hospital Colorado Springs Colorado 80907 —
Aurora Denver Cardiology Denver Colorado 80012 —
George Washington University Washington D.C. District of Columbia 20037 —
Manatee Memorial Bradenton Florida 34209 —
Halifax Medical Center Daytona Beach Florida 32114 —
Baptist Jacksonville Jacksonville Beach Florida 32250 —
Mt. Sinai Medical Center Miami Beach Florida 33140 —
Wuesthoff Hospital Rockledge Florida 32955 —
Bayfront Medical Center St. Petersburg Florida 33705 —
University of South Florida Tampa Florida 33606 —
Florida Medical Center Zephyrhills Florida 33542 —
Piedmont Hospital Atlanta Georgia 30309 —
Emory University Clinic Atlanta Georgia 30322 —
The University of Chicago Chicago Illinois 60637 —
Loyola University Maywood Illinois 60153 —
University of Kansas Hospital Kansas City Kansas 66160 —
Central Baptist Lexington Kentucky 40503 —
Louisiana Heart Lafayette Louisiana 70503 —
Tulane University New Orleans Louisiana 70112 —
University of Maryland Baltimore Maryland 21201 —
Midatlantic Cardiovascular Associates Baltimore Maryland 21218 —
Union Memorial Hospital Baltimore Maryland 21218 —
Shady Grove Adventist Rockville Maryland 20850 —
Tufts University Boston Massachusetts 02111 —
Massachusetts General Hospital Boston Massachusetts 02114 —
New England Cardiovascular Specialists Boston Massachusetts 02135 —
Lahey Clinic Burlington Massachusetts 01805 —
North Shore Medical Center Salem Massachusetts 01970 —
University of Michigan Ann Arbor Michigan 48109 —
St. Joseph Mercy Hospital Ypsilanti Michigan 48197 —
Forrest General Hospital Hattiesburg Mississippi 39402 —
Mid America Heart Kansas City Missouri 64111 —
Barnes Jewish Hospital St Louis Missouri 63110 —
Heart Consultants Omaha Omaha Nebraska 68122 —
Alegent Hospitals Omaha Nebraska 68124 —
Creighton University Omaha Nebraska 68131 —
St. Barnabas West Orange New Jersey 07052 —
Buffalo Heart Group Buffalo New York 14214 —
St. Luke's Roosevelt Hospital New York New York 10025 —
Duke University Medical Center Durham North Carolina 27715 —
Forsyth Medical Center Winston-Salem North Carolina 27103 —
University of Cincinnati Cincinnati Ohio 45267 —
University Hospitals Cleveland Cleveland Ohio 44106 —
Heart and Vascular Center, MetroHealth MC Cleveland Ohio 44109 —
Cleveland Clinic Cleveland Ohio 44195 —
OU Medical Center Presbyterian Oklahoma City Oklahoma 73104 —
Hillcrest Medical Center Tulsa Oklahoma 74104 —
Sacred Heart Medical Center Eugene Oregon 97401 —
Oregon Health Sciences University Portland Oregon 97239 —
Abington Medical Specialists Abington Pennsylvania 19454 —
University of Pennsylvania Philadelphia Pennsylvania 19104 —
Thomas Jefferson University Philadelphia Pennsylvania 19107 —
Medical University of South Carolina Charleston South Carolina 29403 —
South Carolina Heart Center Columbia South Carolina 29204 —
Pee Dee Cardiology Florence South Carolina 29506 —
Spartanburg Regional Medical Center Spartanburg South Carolina 29307 —
Vanderbilt University Nashville Tennessee 37232 —
Amarillo Heart Amarillo Texas 79106 —
Christus Spohn Corpus Christi Texas 78404 —
UT Southwestern Dallas Texas 75390 —
Heart Center of North Texas Fort Worth Texas 76104 —
Sentara Norfolk General Hospital Norfolk Virginia 23502 —
University of Washington Seattle Washington 98195 —
CAMC Memorial Hospital Charleston West Virginia 25304 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00395447, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 14, 2015 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00395447 live on ClinicalTrials.gov.

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