Protego DF4 Post Approval Registry

Terminated

• Conditions: Implantable Defibrillator User

• Registration Number: NCT02243696
• Lead Sponsor: Biotronik, Inc.

Brief Summary

The purpose of this registry study is to confirm the long-term safety and reliability of the Protego DF4 right ventricular lead.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-09-16
• Study First Posted: 2014-09-18
• Study Start: 2014-09-27
• Primary Completion: 2019-04-17
• Study Completion: 2019-04-17
• Results First Submitted: 2020-04-08
• Results First Submitted QC: 2020-04-08
• Results First Posted: 2020-04-22
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-08
• Last Update Posted: 2020-06-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1694

Inclusion Criteria

• Implanted within the last 30 days or candidate for implantation of a BIOTRONIK ICD or CRT-D DF4 compatible system along with the Protego DF4 lead
• Meets ICD or CRT-D system implant recommendations as defined in guidelines published by relevant professional societies
• Able to understand the nature of the registry and provide informed consent
• Available for follow-up visits on a regular basis at the investigational site for the expected 5 years of follow-up
• Age greater than or equal to 18 years

Exclusion Criteria

• Enrolled in any investigational cardiac device trial
• Planned cardiac surgical procedures or interventional measures within the next 6 months
• Expected to receive heart transplantation or ventricular assist device within 1 year
• Life expectancy of less than 1 year
• Presence of another life-threatening, underlying illness separate from their cardiac disorder
• Patients reporting pregnancy at the time of enrollment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With No Protego DF4 Lead Adverse Event	Up to 4.5 years	Evaluate the percentage of subjects without an adverse event related to the Protego DF4 lead or header through 5 years. The endpoint is analyzed as the adverse event free-rate.
Protego DF4 Lead Safety-Individual Adverse Event-Free Rate	Up to 4.5 years	Evaluate the individual types of adverse events contributing to primary outcome measure 'Protego DF4 Lead Safety-Overall Adverse Event-Free Rate'.

Secondary Outcome Measures

Name	Time	Method
Protego DF4 Lead Pacing Threshold Measurement	Up to 4.5 years	Pacing threshold measurements at pulse width of 0.4 or 0.5 ms for the Protego DF4 leads through 5 years of follow-up.
Protego DF4 Lead Sensing	Up to 4.5 years	Sensing measurements for the Protego DF4 leads through 5 years of follow-up.
Protego DF4 Lead Shock Impedance	Up to 4.5 years	Shock impedance measurements for the Protego DF4 leads through 5 years of follow-up.
Protego DF4 Lead Pacing Impedance	Up to 4.5 years	Pacing impedance measurements for the Protego DF4 leads through 5 years of follow-up.
Percentage of Subjects With no Adverse Events Excluded From Primary Objectives	Up to 4.5 years	The overall percentage of patients without adverse events that were excluded from the primary objectives and occurred through 5 years of follow-up. This was evaluated as an adverse event free-rate (AEFR).