Overview

This trial is active, not recruiting.

Condition implantable defibrillator user
Sponsor Biotronik, Inc.
Start date September 2014
End date October 2021
Trial size 1694 participants
Trial identifier NCT02243696, P980023/S057

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Protego DF4 Lead Safety-Overall Adverse Event-Free Rate
time frame: 5 years
Protego DF4 Lead Safety-Individual Adverse Event-Free Rate
time frame: 5 years

Secondary Outcomes

Measure
Protego DF4 lead pacing threshold
time frame: 5 years
Protego DF4 lead shock impedance
time frame: 5 years
Adverse event rate for adverse events excluded from primary endpoints
time frame: 5 years
Protego DF4 lead sensing
time frame: 5 years
Protego DF4 lead pacing impedance
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Protego DF4 Post Approval Registry
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Biotronik, Inc..