Protego DF4 Post Approval Registry

Implantable Defibrillator User Clinical Trial

Official title:

Protego DF4 Post Approval Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02243696
• Other study ID #: P980023/S057
• Status: Terminated
• Start date: September 27, 2014
• Est. completion date: April 17, 2019

Study information

• Verified date: June 2020
• Source: Biotronik, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1694
• Est. completion date: April 17, 2019
• Est. primary completion date: April 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Implantable Defibrillator User

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 With No Protego DF4 Lead Adverse Event	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.	Up to 4.5 years
Primary	Protego DF4 Lead Safety-Individual Adverse Event-Free Rate	Evaluate the individual types of adverse events contributing to primary outcome measure 'Protego DF4 Lead Safety-Overall Adverse Event-Free Rate'.	Up to 4.5 years
Secondary	Protego DF4 Lead Pacing Threshold Measurement	Pacing threshold measurements at pulse width of 0.4 or 0.5 ms for the Protego DF4 leads through 5 years of follow-up.	Up to 4.5 years
Secondary	Protego DF4 Lead Shock Impedance	Shock impedance measurements for the Protego DF4 leads through 5 years of follow-up.	Up to 4.5 years
Secondary	Percentage of Subjects With no Adverse Events Excluded From Primary Objectives	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).	Up to 4.5 years
Secondary	Protego DF4 Lead Sensing	Sensing measurements for the Protego DF4 leads through 5 years of follow-up.	Up to 4.5 years
Secondary	Protego DF4 Lead Pacing Impedance	Pacing impedance measurements for the Protego DF4 leads through 5 years of follow-up.	Up to 4.5 years