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

This study is currently recruiting participants.
Verified March 2013 by Biotronik, Inc.
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.
ClinicalTrials.gov Identifier:
NCT00810264
First received: December 17, 2008
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  Purpose

The objective of this study is to confirm the long-term safety and reliability of the Corox OTW(-S) 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.


Condition Intervention
Congestive Heart Failure
 Device: CRT Therapy - LV Lead Registry

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CELESTIAL Post Approval Registry: Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar Post Approval Registry

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Biotronik, Inc.:

Primary Outcome Measures:
  • Overall complication-free rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2500
Study Start Date: December 2008
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Data Collection Group Device: CRT Therapy - LV Lead Registry
Collecting long-term safety and efficacy data on a market-released left ventricular lead.

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(-S) BP LV lead with a BIOTRONIK CRT device and consented and enrolled between 7-180 days following implant. At least 2000 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • Successfully implanted BIOTRONIK CRT system, including a Corox OTW(-S) 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810264

Contacts
Contact: Kevin Mitchell (503) 675-2153 kevin.mitchell@biotronik.com
Contact: Julie Lambert (503) 451-8071 julie.lambert@biotronik.com

  Show 85 Study Locations
Sponsors and Collaborators
Biotronik, Inc.
  More Information

No publications provided

Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT00810264     History of Changes
Other Study ID Numbers: CELESTIAL
Study First Received: December 17, 2008
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Biotronik, Inc.:
Long-term safety and reliability of a bipolar left ventricular lead on congestive heart failure patients

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013