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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Device: CRT Therapy - LV Lead Registry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Data Collection Group<br> | Device: CRT Therapy - LV Lead Registry<br>* Collecting long-term safety and efficacy data on a market-released left ventricular lead.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 5 years | 
| Percentage of Subjects Experiencing Individual Complications | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long-term safety and reliability of a bipolar left ventricular lead on congestive heart failure patients