REPLACE: Implantable Cardiac Pulse Generator Replacement Registry (REPLACE)

March 24, 2015 updated by: Biotronik, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Device replacements occur for many reasons, including elective replacement indication (ERI), manufacturer advisory, and upgrade.

Recently pacemaker and implantable cardioverter (ICD) advisories have created a dilemma for both physicians and patients. While the risk of device malfunction is low, replacement rates following an advisory are usually high and complication rates following device replacement are not widely known. One retrospective analysis of ICD advisories in Canada reported an 18.3% replacement rate, and subsequent 8.1% complication rate directly related to the replacement.

Device replacements also occur in order to upgrade an existing system. Clinical studies have shown that cardiac resynchronization therapy (CRT) significantly reduces all-cause mortality and hospitalization in patients with advanced heart failure (HF). As a result of expanding indications for this therapy, many standard ICD patients are being upgraded to CRT-D systems. Complication rates related to upgrades of these systems are also not widely known.

To our knowledge, the risk of complications following a device replacement has not been studied prospectively in any patient population. Limited data are available to guide physicians when weighing the risks and benefits of device replacement.

This is a prospective multi-center study. 1750 patients at 100 clinical sites will be enrolled prior to generator replacement. Patients will be implanted and followed for 6 months to assess any complications related to the replacement procedure.

Patients with any legally marketed device for explant can be enrolled. The replacement device can be from any manufacturer.

Study Type

Observational

Enrollment (Actual)

1744

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects with device replacement procedures at study sites

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Straight-forward Device Replacement
Subject with a straight-forward device replacement without lead revisions or additions.
Procedure: Straight-forward Device Replacement
Device Replacement with Upgrade
Subjects with a device replacement and planned lead upgrade, revision, or addition.
Procedure: Device Replacement with Upgrade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 6 months
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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik, Inc.

Investigators

  • Principal Investigator: Jeanne Poole, MD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

November 1, 2006

First Submitted That Met QC Criteria

November 2, 2006

First Posted (Estimate)

November 3, 2006

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REPLACE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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