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

NCT00810264 | Completed Results

• 1 other identifier: CELESTIAL
• Study Type: observational
• Target: 2,499
• Locations: 1 country
• Sites: 86

Brief 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.

Conditions

Congestive Heart Failure

Keywords

Long-term safety and reliability of a bipolar left ventricular lead on congestive heart failure patients

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects Who Are Free of Complications Related to the Corox LV Lead

  The overall incidence of serious adverse events that require additional invasive intervention to resolve, related to the Corox BP LV leads implanted with either BIOTRONIK CRT-P or CRT-D devices.This was evaluated as a serious adverse event free-rate (SAEFR).

  5 years

• Percentage of Subjects Experiencing Individual Complications

  Evaluation of the individual types of serious adverse events contributing to primary outcome 1.

  5 years

Secondary Outcomes (10)

• Mean Successful Biventricular Pacing in Subjects at the 5 Year In-office Visit.

  5 years

• Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint

  5 years

• Corox BP LV Lead Pacing Threshold Measurements

  5 years

• Corox BP LV Lead Sensing Measurements

  5 years

• Corox BP LV Lead Impedance Measurements

  5 years

Study Arms (1)

Data Collection Group

Device: CRT Therapy - LV Lead Registry

Interventions

CRT Therapy - LV Lead Registry DEVICE

Collecting long-term safety and efficacy data on a market-released left ventricular lead.

Data Collection Group

Eligibility Criteria

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

Study Population

Patients will be obtained from the investigators' general patient population according to the inclusion and exclusion criteria described below.

You may qualify if:

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

You may not qualify if:

• Enrolled in any IDE clinical study
• Planned cardiac surgical procedures or interventional measures within the next 6 months
• 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 cardiac disorder
• Pregnancy
• Inability to provide date of implant, devices implanted, age, gender, and whether the patient experienced any protocol-defined adverse events since implant

Sponsors & Collaborators

• Biotronik, Inc.: lead

Study Sites (86)

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Birmingham, Alabama, United States

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Glendale, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Anaheim, California, United States

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Fairfield, California, United States

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Fountain Valley, California, United States

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Glendale, California, United States

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Hawthorne, California, United States

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Inglewood, California, United States

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Los Angeles, California, United States

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National City, California, United States

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Northridge, California, United States

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Orange, California, United States

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Rancho Mirage, California, United States

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Santa Barbara, California, United States

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Torrance, California, United States

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Ventura, California, United States

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Watsonville, California, United States

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Aurora, Colorado, United States

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Boulder, Colorado, United States

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Danbury, Connecticut, United States

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Brooksville, Florida, United States

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Davenport, Florida, United States

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Melbourne, Florida, United States

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Naples, Florida, United States

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New Smyrna Beach, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Macon, Georgia, United States

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Urbana, Illinois, United States

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Fort Wayne, Indiana, United States

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Valparaiso, Indiana, United States

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Owensboro, Kentucky, United States

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Covington, Louisiana, United States

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Hammond, Louisiana, United States

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Lafayette, Louisiana, United States

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Bangor, Maine, United States

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Baltimore, Maryland, United States

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Cumberland, Maryland, United States

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Lanham, Maryland, United States

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Rockville, Maryland, United States

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Burlington, Massachusetts, United States

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Worcester, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Lansing, Michigan, United States

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Lapeer, Michigan, United States

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Saginaw, Michigan, United States

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Wyoming, Michigan, United States

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Ypsilanti, Michigan, United States

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Tupelo, Mississippi, United States

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Crystal City, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Glen Ridge, New Jersey, United States

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New York, New York, United States

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Rochester, New York, United States

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Gastonia, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Columbus, Ohio, United States

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Middletown, Ohio, United States

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Steubenville, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Salem, Oregon, United States

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Chinchilla, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pottstown, Pennsylvania, United States

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Yardley, Pennsylvania, United States

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Columbia, South Carolina, United States

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Greenville, South Carolina, United States

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Spartanburg, South Carolina, United States

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Chattanooga, Tennessee, United States

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Amarillo, Texas, United States

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Brownsville, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Kingwood, Texas, United States

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McKinney, Texas, United States

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Nacogdoches, Texas, United States

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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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Related Publications (1)

• Good ED, Cakulev I, Orlov MV, Hirsh D, Simeles J, Mohr K, Moll P, Bloom H. Long-Term Evaluation of Biotronik Linox and Linox(smart) Implantable Cardioverter Defibrillator Leads. J Cardiovasc Electrophysiol. 2016 Jun;27(6):735-42. doi: 10.1111/jce.12971. Epub 2016 May 3.

  PMID: 26990515 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Clinical Studies Engineer Group Manager
• Organization: BIOTRONIK

celestial@biotronik.com

800-547-0394

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: December 17, 2008
• First Posted: December 18, 2008
• Study Start: December 1, 2008
• Primary Completion: November 2, 2018
• Study Completion: November 2, 2018
• Last Updated: November 29, 2019
• Results First Posted: November 29, 2019

Record last verified: 2019-11

Locations

US (86)