Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar

Last updated: November 11, 2019
Sponsor: Biotronik, Inc.
Overall Status: Completed

Phase

N/A

Condition

Heart Disease

Congestive Heart Failure

Heart Failure

Treatment

N/A

Clinical Study ID

NCT00810264
CELESTIAL
  • Ages > 18
  • All Genders

Study Summary

The objective of this study is to confirm the long-term safety and reliability of the Corox OTW BP left ventricular (LV) pacing lead. As a condition of approval, the FDA required that a registry documenting the post approval clinical experience of these leads be designed and implemented.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Successfully implanted BIOTRONIK CRT system, including a Corox BP LV lead, from 7-180days prior to enrollment

  • Able to understand the nature of the registry and give informed consent

  • Available for follow-up visits on a regular basis at the investigational site

  • Age greater than or equal to 18 years

Exclusion

Exclusion Criteria:

  • Enrolled in any IDE clinical study

  • Planned cardiac surgical procedures or interventional measures within the next 6months

  • Expected to receive a heart transplant within 1 year

  • Life expectancy less than 1 year

  • Presence of another life-threatening, underlying illness separate from their cardiacdisorder

  • Pregnancy

  • Inability to provide date of implant, devices implanted, age, gender, and whether thepatient experienced any protocol-defined adverse events since implant

Study Design

Total Participants: 2499
Study Start date:
December 01, 2008
Estimated Completion Date:
November 02, 2018

Study Description

This study is an FDA-required, multi-center, prospective, non-randomized, data collection registry. Eligible patients must have been successfully implanted with a Corox OTW BP, Corox OTW-S BP, or Corox OTW-L BP LV lead with a BIOTRONIK CRT device and consented and enrolled between 7-180 days following implant. At least 2500 patients will be enrolled in this post-approval registry, and each patient will be followed for five years post-implant.

Safety will be evaluated based on the analysis of the overall incidence of lead-related adverse events that require additional invasive intervention. In addition, each individual adverse event will be separately investigated. Lead parameters for sensing, pacing thresholds, and impedance will also be evaluated. Reporting of all adverse events will be performed twice a year in order to identify and characterize any trends in adverse events, failure modes, or failure rates.

Connect with a study center

  • Birmingham, Alabama
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  • Mesa, Arizona
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  • Phoenix, Arizona
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  • Scottsdale, Arizona
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  • Tucson, Arizona
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  • Anaheim, California
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  • Fairfield, California
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  • Fountain Valley, California
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  • Glendale, California
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    Hawthorn, California
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  • Hawthorne, California
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  • Inglewood, California
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  • Los Angeles, California
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  • National City, California
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  • Northridge, California
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  • Orange, California
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  • Rancho Mirage, California
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  • Santa Barbara, California
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  • Torrance, California
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  • Ventura, California
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  • Watsonville, California
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  • Aurora, Colorado
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  • Boulder, Colorado
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  • Danbury, Connecticut
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  • Brooksville, Florida
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  • Davenport, Florida
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    Edgewater, Florida
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    Land O' Lakes, Florida
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  • Melbourne, Florida
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  • Naples, Florida
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  • New Smyrna Beach, Florida
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  • Saint Petersburg, Florida
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    St. Petersburg, Florida
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  • Tampa, Florida
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  • Macon, Georgia
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  • Urbana, Illinois
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  • Fort Wayne, Indiana
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  • Valparaiso, Indiana
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  • Owensboro, Kentucky
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  • Covington, Louisiana
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  • Hammond, Louisiana
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  • Lafayette, Louisiana
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  • Bangor, Maine
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  • Baltimore, Maryland
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  • Cumberland, Maryland
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  • Lanham, Maryland
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  • Rockville, Maryland
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  • Burlington, Massachusetts
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  • Worcester, Massachusetts
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  • Ann Arbor, Michigan
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  • Lansing, Michigan
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  • Lapeer, Michigan
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  • Saginaw, Michigan
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  • Wyoming, Michigan
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  • Ypsilanti, Michigan
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  • Tupelo, Mississippi
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  • Crystal City, Missouri
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  • Saint Louis, Missouri
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    St. Louis, Missouri
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  • Las Vegas, Nevada
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  • Glen Ridge, New Jersey
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  • New York, New York
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  • Rochester, New York
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  • Gastonia, North Carolina
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  • Winston-Salem, North Carolina
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  • Columbus, Ohio
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  • Middletown, Ohio
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  • Steubenville, Ohio
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  • Toledo, Ohio
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  • Oklahoma City, Oklahoma
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  • Salem, Oregon
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  • Chinchilla, Pennsylvania
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  • Lancaster, Pennsylvania
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  • Philadelphia, Pennsylvania
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  • Pottstown, Pennsylvania
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  • Yardley, Pennsylvania
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  • Columbia, South Carolina
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  • Greenville, South Carolina
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  • Spartanburg, South Carolina
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  • Chattanooga, Tennessee
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  • Amarillo, Texas
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  • Brownsville, Texas
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  • Corpus Christi, Texas
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  • Dallas, Texas
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  • Kingwood, Texas
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  • McKinney, Texas
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  • Nacogdoches, Texas
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  • Fredericksburg, Virginia
    United States

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  • Spokane, Washington
    United States

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  • Yakima, Washington
    United States

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