REPLACE: Implantable Cardiac Pulse Generator Replacement Registry

NCT00395447 | Completed Results DMC

• 1 other identifier: REPLACE
• Study Type: observational
• Target: 1,744
• Locations: 1 country
• Sites: 71

Brief 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

Keywords

Cardiac Pacemaker; Defibrillator; Replacement; Upgrade

Outcome Measures

Primary Outcomes (1)

• 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)

  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

Study Arms (2)

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

Interventions

Straight-forward Device Replacement PROCEDURE

Straight-forward Device Replacement

Device Replacement with Upgrade PROCEDURE

Device Replacement with Upgrade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with device replacement procedures at study sites

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik, Inc.: lead

Study Sites (71)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Mesa Cardiovascular

Mesa, Arizona, 85206, United States

Location

Stanislaus Cardiology

Modesto, California, 95355, United States

Location

Desert Cardiology

Rancho Mirage, California, 92270, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

UCSD Medical Center

San Diego, California, 92103, United States

Location

UCSF

San Francisco, California, 94143, United States

Location

Penrose Hospital

Colorado Springs, Colorado, 80907, United States

Location

Aurora Denver Cardiology

Denver, Colorado, 80012, United States

Location

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Manatee Memorial

Bradenton, Florida, 34209, United States

Location

Halifax Medical Center

Daytona Beach, Florida, 32114, United States

Location

Baptist Jacksonville

Jacksonville Beach, Florida, 32250, United States

Location

Mt. Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Wuesthoff Hospital

Rockledge, Florida, 32955, United States

Location

Bayfront Medical Center

St. Petersburg, Florida, 33705, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Florida Medical Center

Zephyrhills, Florida, 33542, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Emory University Clinic

Atlanta, Georgia, 30322, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Loyola University

Maywood, Illinois, 60153, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Central Baptist

Lexington, Kentucky, 40503, United States

Location

Louisiana Heart

Lafayette, Louisiana, 70503, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Midatlantic Cardiovascular Associates

Baltimore, Maryland, 21218, United States

Location

Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Shady Grove Adventist

Rockville, Maryland, 20850, United States

Location

Tufts University

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

New England Cardiovascular Specialists

Boston, Massachusetts, 02135, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

North Shore Medical Center

Salem, Massachusetts, 01970, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

St. Joseph Mercy Hospital

Ypsilanti, Michigan, 48197, United States

Location

Forrest General Hospital

Hattiesburg, Mississippi, 39402, United States

Location

Mid America Heart

Kansas City, Missouri, 64111, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Heart Consultants Omaha

Omaha, Nebraska, 68122, United States

Location

Alegent Hospitals

Omaha, Nebraska, 68124, United States

Location

Creighton University

Omaha, Nebraska, 68131, United States

Location

St. Barnabas

West Orange, New Jersey, 07052, United States

Location

Buffalo Heart Group

Buffalo, New York, 14214, United States

Location

St. Luke's Roosevelt Hospital

New York, New York, 10025, United States

Location

Duke University Medical Center

Durham, North Carolina, 27715, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

University Hospitals Cleveland

Cleveland, Ohio, 44106, United States

Location

Heart and Vascular Center, MetroHealth MC

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

OU Medical Center Presbyterian

Oklahoma City, Oklahoma, 73104, United States

Location

Hillcrest Medical Center

Tulsa, Oklahoma, 74104, United States

Location

Sacred Heart Medical Center

Eugene, Oregon, 97401, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

Abington Medical Specialists

Abington, Pennsylvania, 19454, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

South Carolina Heart Center

Columbia, South Carolina, 29204, United States

Location

Pee Dee Cardiology

Florence, South Carolina, 29506, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29307, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Amarillo Heart

Amarillo, Texas, 79106, United States

Location

Christus Spohn

Corpus Christi, Texas, 78404, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Heart Center of North Texas

Fort Worth, Texas, 76104, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23502, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

CAMC Memorial Hospital

Charleston, West Virginia, 25304, United States

Location

Related Publications (3)

• Chung MK, Holcomb RG, Mittal S, Steinberg JS, Gleva MJ, Mela T, Uslan DZ, Mitchell K, Poole JE; REPLACE Investigators. REPLACE DARE (Death After Replacement Evaluation) score: determinants of all-cause mortality after implantable device replacement or upgrade from the REPLACE registry. Circ Arrhythm Electrophysiol. 2014 Dec;7(6):1048-56. doi: 10.1161/CIRCEP.114.001671. Epub 2014 Sep 14.

  PMID: 25221331 DERIVED

• Uslan DZ, Gleva MJ, Warren DK, Mela T, Chung MK, Gottipaty V, Borge R, Dan D, Shinn T, Mitchell K, Holcomb RG, Poole JE. Cardiovascular implantable electronic device replacement infections and prevention: results from the REPLACE Registry. Pacing Clin Electrophysiol. 2012 Jan;35(1):81-7. doi: 10.1111/j.1540-8159.2011.03257.x. Epub 2011 Nov 11.

  PMID: 22077194 DERIVED

• Poole JE, Gleva MJ, Mela T, Chung MK, Uslan DZ, Borge R, Gottipaty V, Shinn T, Dan D, Feldman LA, Seide H, Winston SA, Gallagher JJ, Langberg JJ, Mitchell K, Holcomb R; REPLACE Registry Investigators. Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation. 2010 Oct 19;122(16):1553-61. doi: 10.1161/CIRCULATIONAHA.110.976076. Epub 2010 Oct 4.

  PMID: 20921437 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Crystal Miller, Clinical Studies Engineer
• Organization: BIOTRONIK, Inc

crystal.miller@biotronik.com

503-451-8051

Study Officials

• Jeanne Poole, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2006
• First Posted: November 3, 2006
• Study Start: July 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: April 14, 2015
• Results First Posted: November 30, 2010

Record last verified: 2015-03

Locations

US (71)