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

Congestive Heart Failure Clinical Trial

— CELESTIAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810264
• Other study ID #: CELESTIAL
• Status: Completed
• Start date: December 2008
• Est. completion date: November 2, 2018

Study information

• Verified date: November 2019
• Source: Biotronik, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2499
• Est. completion date: November 2, 2018
• Est. primary completion date: November 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• CRT Therapy - LV Lead Registry
Collecting long-term safety and efficacy data on a market-released left ventricular lead.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percentage of Subjects Experiencing Individual Complications	Evaluation of the individual types of serious adverse events contributing to primary outcome 1.	5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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