Plexa ICD Lead Registry

N/ATerminatedNCT03103503

Biotronik, Inc.901 enrolled

Overview

The purpose of this registry is to confirm the long-term safety and reliability of BIOTRONIK's Plexa ICD lead.

Study Type

OBSERVATIONAL

Enrollment

901

Conditions

Implantable Defibrillator User

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (28)

Outcomes

Primary Outcomes

Percentage of Subjects Free From Plexa Lead Related Adverse Events

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.

Time frame: Up to 2.5 years

Secondary Outcomes

Plexa Lead Safety-Individual Adverse Events

Evaluate the individual types of adverse events contributing to primary outcome measure 'Percentage of Subjects Free From Plexa Lead Related Adverse Events'

Time frame: Up to 2.5 years

Pacing Threshold Measurements for the Plexa Lead Through Study Termination

Pacing threshold measurements at pulse width of 0.4 for the Plexa leads at completed follow-up visits.

Time frame: Up to 2.5 years

Sensing Measurements for the Plexa Lead Through Study Termination

Sensing measurements for the Plexa leads at completed follow-up visits.

Time frame: Up to 2.5 years

Pacing Impedance Measurements for the Plexa Lead Through Study Termination

Pacing impedance measurements for the Plexa leads at completed follow-up visits.

Time frame: Up to 2.5 years

Shock Impedance for the Plexa Lead Through Study Termination

Shock impedance measurements for the Plexa leads at completed follow-up visits.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Thomas Hospital Research Office

Fairhope, Alabama, United States

Jeffrey S Goodman MD

Los Angeles, California, United States

Eisenhower Desert Cardiology

Rancho Mirage, California, United States

Florida Hospital

Orlando, Florida, United States

Advent Health Tampa

Tampa, Florida, United States

St. Louis Cardiology Consultants

Alton, Illinois, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Heartland Cardiology

Wichita, Kansas, United States

Research Integrity LLC

Owensboro, Kentucky, United States

Northern Light Cardiology

Bangor, Maine, United States

...and 18 more locations