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

Completed

• Conditions: Congestive Heart Failure
• Interventions: Device: CRT Therapy - LV Lead Registry

• Registration Number: NCT00810264
• Lead Sponsor: Biotronik, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-17
• Study First Submitted QC: 2008-12-17
• Study First Posted: 2008-12-18
• Primary Completion: 2018-11-02
• Study Completion: 2018-11-02
• Results First Submitted: 2019-10-08
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-11
• Last Update Submitted: 2019-11-11
• Results First Posted: 2019-11-29
• Last Update Posted: 2019-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2499

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Data Collection Group	CRT Therapy - LV Lead Registry	-

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Who Are Free of Complications Related to the Corox LV Lead	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).
Percentage of Subjects Experiencing Individual Complications	5 years	Evaluation of the individual types of serious adverse events contributing to primary outcome 1.

Secondary Outcome Measures

Name	Time	Method
Mean Successful Biventricular Pacing in Subjects at the 5 Year In-office Visit.	5 years	Successful biventricular pacing in a BIOTRONIK CRT device at scheduled CELESTIAL registry follow-up visits through 5 years post-implant.
Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint	5 years	Serious adverse event rates for SAEs excluded from primary safety endpoint through 5 years post-implant.
Corox BP LV Lead Pacing Threshold Measurements	5 years	Pacing threshold measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.
Overall Incidence of Primary Endpoint 1 Serious Adverse Events for Each Corox BP Lead Model	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.
Corox BP LV Lead Sensing Measurements	5 years	Sensing measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.
Corox BP LV Lead Impedance Measurements	5 years	Impedance measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.
Pacing Threshold Measurements Per Corox BP LV Lead Model	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.
Sensing Measurements Per Corox BP LV Lead Model	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.
Impedance Measurements Per Corox BP LV Lead Model	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.
Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model	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.