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Congestive Heart FailureCELESTIALNCT00810264

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

An observational study of Congestive Heart Failure, run by Biotronik, Inc. at 86 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Congestive Heart Failure
What is being tested?
CRT Therapy - LV Lead Registry
Type of treatment
Medical device
How many people
2,499 participants
Where
86 sitesUnited States
Study dates
Dec 2008to 2 Nov 2018
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

86 sites in 1 country.

86 sites in 1 country

United States86 sites

  • Study site

    Amarillo, Texas

  • Study site

    Anaheim, California

  • Study site

    Ann Arbor, Michigan

  • Study site

    Aurora, Colorado

  • Study site

    Baltimore, Maryland

  • Study site

    Bangor, Maine

  • Study site

    Birmingham, Alabama

  • Study site

    Boulder, Colorado

  • Study site

    Brooksville, Florida

  • Study site

    Brownsville, Texas

  • Study site

    Burlington, Massachusetts

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chinchilla, Pennsylvania

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Ohio

  • Study site

    Corpus Christi, Texas

  • Study site

    Covington, Louisiana

  • Study site

    Crystal City, Missouri

  • Study site

    Cumberland, Maryland

  • Study site

    Dallas, Texas

  • Study site

    Danbury, Connecticut

  • Study site

    Davenport, Florida

  • Study site

    Fairfield, California

  • Study site

    Fort Wayne, Indiana

  • Study site

    Fountain Valley, California

  • Study site

    Fredericksburg, Virginia

  • Study site

    Gastonia, North Carolina

  • Study site

    Glen Ridge, New Jersey

  • Study site

    Glendale, Arizona

  • Study site

    Glendale, California

  • Study site

    Greenville, South Carolina

  • Study site

    Hammond, Louisiana

  • Study site

    Hawthorne, California

  • Study site

    Inglewood, California

  • Study site

    Kingwood, Texas

  • Study site

    Lafayette, Louisiana

  • Study site

    Lancaster, Pennsylvania

  • Study site

    Lanham, Maryland

  • Study site

    Lansing, Michigan

  • Study site

    Lapeer, Michigan

  • Study site

    Las Vegas, Nevada

  • Study site

    Los Angeles, California

  • Study site

    Macon, Georgia

  • Study site

    McKinney, Texas

  • Study site

    Melbourne, Florida

  • Study site

    Mesa, Arizona

  • Study site

    Middletown, Ohio

  • Study site

    Nacogdoches, Texas

  • Study site

    Naples, Florida

  • Study site

    National City, California

  • Study site

    New Smyrna Beach, Florida

  • Study site

    New York, New York

  • Study site

    Northridge, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orange, California

  • Study site

    Owensboro, Kentucky

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Pottstown, Pennsylvania

  • Study site

    Rancho Mirage, California

  • Study site

    Rochester, New York

  • Study site

    Rockville, Maryland

  • Study site

    Saginaw, Michigan

  • Study site

    Salem, Oregon

  • Study site

    Santa Barbara, California

  • Study site

    Scottsdale, Arizona

  • Study site

    Spartanburg, South Carolina

  • Study site

    Spokane, Washington

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Steubenville, Ohio

  • Study site

    Tampa, Florida

  • Study site

    Toledo, Ohio

  • Study site

    Torrance, California

  • Study site

    Tucson, Arizona

  • Study site

    Tupelo, Mississippi

  • Study site

    Urbana, Illinois

  • Study site

    Valparaiso, Indiana

  • Study site

    Ventura, California

  • Study site

    Watsonville, California

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Worcester, Massachusetts

  • Study site

    Wyoming, Michigan

  • Study site

    Yakima, Washington

  • Study site

    Yardley, Pennsylvania

  • Study site

    Ypsilanti, Michigan

Other trials in United States

About this study

Official title: CELESTIAL Post Approval Registry: Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar Post Approval Registry

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.

Read the detailed 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.

Being tested
CRT Therapy - LV Lead Registry
Keywords
Long-term safety and reliability of a bipolar left ventricular lead on congestive heart failure patients
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CRT Therapy - LV Lead RegistryDevice

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

Study groups in NCT00810264
Study groupRoleWhat they receive
Data Collection GroupNot described
Receives: Device: CRT Therapy - LV Lead Registry

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 5 years

  2. Percentage of Subjects Experiencing Individual Complications

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

    Measured: 5 years

Secondary outcomes (10)

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

    Successful biventricular pacing in a BIOTRONIK CRT device at scheduled CELESTIAL registry follow-up visits through 5 years post-implant.

    Measured: 5 years

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

    Serious adverse event rates for SAEs excluded from primary safety endpoint through 5 years post-implant.

    Measured: 5 years

  3. Corox BP LV Lead Pacing Threshold Measurements

    Pacing threshold measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.

    Measured: 5 years

  4. Corox BP LV Lead Sensing Measurements

    Sensing measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.

    Measured: 5 years

  5. Corox BP LV Lead Impedance Measurements

    Impedance measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.

    Measured: 5 years

  6. Pacing Threshold Measurements Per Corox BP LV Lead Model

    Pacing threshold measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.

    Measured: 5 years

  7. Sensing Measurements Per Corox BP LV Lead Model

    Sensing measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.

    Measured: 5 years

  8. Impedance Measurements Per Corox BP LV Lead Model

    Impedance measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.

    Measured: 5 years

  9. Overall Incidence of Primary Endpoint 1 Serious Adverse Events for Each Corox BP Lead Model

    Overall incidence of serious adverse events that meet the primary endpoint 1 criteria will be evaluated separately for each Corox BP lead model.

    Measured: 5 years

  10. Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model

    Incidence of individual types of serious adverse events contributing to primary endpoint 2 will be evaluated separately for each Corox BP lead model.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2008 (estimated)
  2. Study startDec 2008
  3. Primary completion2 Nov 2018
  4. Study completion2 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,499 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00810264
Sponsor's protocol ID
CELESTIAL
Acronym
CELESTIAL
Status last verified
Nov 2019
First submitted
17 Dec 2008
Last updated
29 Nov 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 26990515

Questions about this trial

What is this clinical trial studying?

An observational study of Congestive Heart Failure, run by Biotronik, Inc. at 86 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects Who Are Free of Complications Related to the Corox LV Lead (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00810264, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.

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