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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Biotronik, Inc.

ClinicalTrials.gov Identifier:

NCT00810264

First received: December 17, 2008

Last updated: August 4, 2016

Last verified: August 2016

History of Changes

Purpose

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.

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 ]
Individual complication rates [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	2500
Study Start Date:	December 2008
Estimated Study Completion Date:	October 2018
Estimated Primary Completion Date:	October 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 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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810264

Show 86 Study Locations

Sponsors and Collaborators

Biotronik, Inc.

More Information


Responsible Party:	Biotronik, Inc.
ClinicalTrials.gov Identifier:	NCT00810264 History of Changes
Other Study ID Numbers:	CELESTIAL
Study First Received:	December 17, 2008
Last Updated:	August 4, 2016
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 September 27, 2016

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