Plexa ICD Lead Registry

Terminated

Conditions: Implantable Defibrillator User

Registration Number: NCT03103503

Lead Sponsor: Biotronik, Inc.

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

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 901

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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'
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.
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.

Trial Locations

Locations (28): 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
Research Integrity LLC
🇺🇸
Owensboro, Kentucky, United States
Cardiovascular Associates Ltd
🇺🇸
Virginia Beach, Virginia, United States
Mercy Clinic Cardiology
🇺🇸
Springfield, Missouri, United States
Glacier View Research Institute Cardiology
🇺🇸
Kalispell, Montana, United States
The Ohio State Wexner Medical Center
🇺🇸
Columbus, Ohio, United States
Heartland Cardiology
🇺🇸
Wichita, Kansas, United States
Sanford Medical Center
🇺🇸
Fargo, North Dakota, 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
Michigan Heart
🇺🇸
Ypsilanti, Michigan, United States
Gateway Cardiovascular Research Center
🇺🇸
Saint Louis, Missouri, United States
Northern Light Cardiology
🇺🇸
Bangor, Maine, United States
Metro Health Hospital
🇺🇸
Wyoming, Michigan, United States
Mercy Clinic Heart and Vascular
🇺🇸
Saint Louis, Missouri, United States
St. Louis Heart and Vascular
🇺🇸
Saint Louis, Missouri, United States
Upstate Cardiology
🇺🇸
Greenville, South Carolina, United States
Toledo Cardiology
🇺🇸
Toledo, Ohio, United States
The Arrhythmia Institute
🇺🇸
Newtown, Pennsylvania, United States
Carolina Heart Specialists
🇺🇸
Lancaster, South Carolina, United States
Carolina Cardiology Associates
🇺🇸
Rock Hill, South Carolina, United States
Florida Hospital
🇺🇸
Orlando, Florida, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
Novant Health
🇺🇸
Winston-Salem, North Carolina, United States
Deborah Heart and Lung Center
🇺🇸
Browns Mills, New Jersey, United States