Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar (CELESTIAL)
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ClinicalTrials.gov Identifier: NCT00810264 |
Recruitment Status
:
Active, not recruiting
First Posted
: December 18, 2008
Last Update Posted
: April 13, 2018
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Condition or disease | Intervention/treatment |
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Congestive Heart Failure | Device: CRT Therapy - LV Lead Registry |
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 |
Estimated Enrollment : | 2500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | CELESTIAL Post Approval Registry: Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar Post Approval Registry |
Study Start Date : | December 2008 |
Estimated Primary Completion Date : | October 2018 |
Estimated Study Completion Date : | October 2018 |

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.
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- Overall complication-free rate [ Time Frame: 5 years ]
- Individual complication rates [ Time Frame: 5 years ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810264

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Biotronik, Inc. |
ClinicalTrials.gov Identifier: | NCT00810264 History of Changes |
Other Study ID Numbers: |
CELESTIAL |
First Posted: | December 18, 2008 Key Record Dates |
Last Update Posted: | April 13, 2018 |
Last Verified: | April 2018 |
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 |