Plexa ICD Lead Registry

Primary outcomes

• Percentage of Subjects Free From Plexa Lead Related Adverse Events [Up to 2.5 years]: Evaluate the percentage of subjects without an adverse event related to the Plexa lead through study termination. The endpoint is analyzed as the adverse event free-rate. All protocol defined adverse events that occurred more than 30 days after implant and determined to be related to the Plexa lead plus required invasive intervention to resolve or were related to a lead integrity or clinical performance issue were included. Events meeting this criteria but occurring within 30 days were also included except for lead dislodgement, high pacing threshold, failure to capture, or intermittent capture.

Secondary outcomes

• Plexa Lead Safety-Individual Adverse Events [Up to 2.5 years]: Evaluate the individual types of adverse events contributing to primary outcome measure 'Percentage of Subjects Free From Plexa Lead Related Adverse Events'
• Pacing Threshold Measurements for the Plexa Lead Through Study Termination [Up to 2.5 years]: Pacing threshold measurements at pulse width of 0.4 for the Plexa leads at completed follow-up visits.
• Sensing Measurements for the Plexa Lead Through Study Termination [Up to 2.5 years]: Sensing measurements for the Plexa leads at completed follow-up visits.
• Pacing Impedance Measurements for the Plexa Lead Through Study Termination [Up to 2.5 years]: Pacing impedance measurements for the Plexa leads at completed follow-up visits.
• Shock Impedance for the Plexa Lead Through Study Termination [Up to 2.5 years]: Shock impedance measurements for the Plexa leads at completed follow-up visits.
• Percentage of Subjects Free From Protocol Defined Adverse Events [Up to 2.5 years]: Evaluate the percentage of subjects without a protocol defined and clinical event committee adjudicated adverse event, excluding events included in the primary outcome 'Percentage of Subjects Free From Plexa Lead Related Adverse Events', through study termination. Lead dislodgements, high pacing threshold, failure to capture, and intermittent capture related to the Plexa lead that occurred less than or equal to 30 days after lead implant or a lead revision procedure are included here. The endpoint is analyzed as the adverse event free-rate.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Successfully implanted with a BIOTRONIK ICD or CRT-D compatible system along with the Plexa lead no more than 30 days prior to consent
* Able to understand the nature of the registry and provide informed consent
* Available for follow-up visits on a regular basis at the study site for the expected 5 years of follow-up
* Accepts BIOTRONIK Home Monitoring® concept
* Age greater than or equal to 18 years

Exclusion Criteria:

* Enrolled in any investigational cardiac device trial
* Enrolled in BIOTRONIK's QP ExCELs lead study
* 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
* Patients reporting pregnancy at the time of enrollment

Participant flow

Outcome results

• Percentage of Subjects Free From Plexa Lead Related Adverse Events (Primary), Number, percentage of participants: BIOTRONIK Plexa ICD Lead 100.00 (99.49 to 100.00)
• Plexa Lead Safety-Individual Adverse Events (Secondary)
• Pacing Threshold Measurements for the Plexa Lead Through Study Termination (Secondary), Mean, V: BIOTRONIK Plexa ICD Lead 0.63 +/- 0.28
• Sensing Measurements for the Plexa Lead Through Study Termination (Secondary), Mean, mV: BIOTRONIK Plexa ICD Lead 15.88 +/- 5.56
• Pacing Impedance Measurements for the Plexa Lead Through Study Termination (Secondary), Mean, ohms: BIOTRONIK Plexa ICD Lead 567.1 +/- 111.2
• Shock Impedance for the Plexa Lead Through Study Termination (Secondary), Mean, ohms: BIOTRONIK Plexa ICD Lead 75.1 +/- 13.7
• Percentage of Subjects Free From Protocol Defined Adverse Events (Secondary), Number, percentage of participants: BIOTRONIK Plexa ICD Lead 95.12 (93.49 to 96.36)

Adverse events

Time frame: Though study exit or study termination, an average of 1.1 years

Serious adverse events by term

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2017-03-01)