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

November 11, 2019 updated by: Biotronik, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

2499

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

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

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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
Data Collection Group
Device: CRT Therapy - LV Lead Registry
Collecting long-term safety and efficacy data on a market-released left ventricular lead.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Who Are Free of Complications Related to the Corox LV Lead
Time Frame: 5 years
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
Time Frame: 5 years
Evaluation of the individual types of serious adverse events contributing to primary outcome 1.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Successful Biventricular Pacing in Subjects at the 5 Year In-office Visit.
Time Frame: 5 years
Successful biventricular pacing in a BIOTRONIK CRT device at scheduled CELESTIAL registry follow-up visits through 5 years post-implant.
5 years
Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint
Time Frame: 5 years
Serious adverse event rates for SAEs excluded from primary safety endpoint through 5 years post-implant.
5 years
Corox BP LV Lead Pacing Threshold Measurements
Time Frame: 5 years
Pacing threshold measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.
5 years
Corox BP LV Lead Sensing Measurements
Time Frame: 5 years
Sensing measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.
5 years
Corox BP LV Lead Impedance Measurements
Time Frame: 5 years
Impedance measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.
5 years
Pacing Threshold Measurements Per Corox BP LV Lead Model
Time Frame: 5 years
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.
5 years
Sensing Measurements Per Corox BP LV Lead Model
Time Frame: 5 years
Sensing measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.
5 years
Impedance Measurements Per Corox BP LV Lead Model
Time Frame: 5 years
Impedance measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.
5 years
Overall Incidence of Primary Endpoint 1 Serious Adverse Events for Each Corox BP Lead Model
Time Frame: 5 years
Overall incidence of serious adverse events that meet the primary endpoint 1 criteria will be evaluated separately for each Corox BP lead model.
5 years
Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model
Time Frame: 5 years
Incidence of individual types of serious adverse events contributing to primary endpoint 2 will be evaluated separately for each Corox BP lead model.
5 years

Collaborators and Investigators

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

Sponsor

Biotronik, Inc.

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

December 1, 2008

Primary Completion (Actual)

November 2, 2018

Study Completion (Actual)

November 2, 2018

Study Registration Dates

First Submitted

December 17, 2008

First Submitted That Met QC Criteria

December 17, 2008

First Posted (Estimate)

December 18, 2008

Study Record Updates

Last Update Posted (Actual)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 11, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CELESTIAL

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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