MedTrace Logo

REPLACE: Implantable Cardiac Pulse Generator Replacement Registry

NCT00395447 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1744

Last updated 2015-04-14

Study results available
· View outcomes & findings →

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

  • Device Replacement
  • Elective Replacement (ERI)
  • Device Advisory
  • Device Upgrade
  • Postoperative Complications

Interventions

PROCEDURE

Straight-forward Device Replacement

PROCEDURE

Device Replacement with Upgrade

Sponsors & Collaborators

  • Biotronik, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeanne Poole, MD · University of Washington

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00395447 on ClinicalTrials.gov