Plexa ICD Lead Registry

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

Study Overview

• Status: Terminated
• Conditions: Implantable Defibrillator User

• Study Type: Observational
• Enrollment (Actual): 901

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Fairhope, Alabama, United States, 36532
      • Thomas Hospital Research Office
  • California
    • Los Angeles, California, United States, 90048
      • Jeffrey S Goodman MD
    • Rancho Mirage, California, United States, 92270
      • Eisenhower Desert Cardiology
  • Florida
    • Orlando, Florida, United States, 32803
      • Florida Hospital
    • Tampa, Florida, United States, 33613
      • Advent Health Tampa
  • Illinois
    • Alton, Illinois, United States, 62002
      • St. Louis Cardiology Consultants
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kansas
    • Wichita, Kansas, United States, 67205
      • Heartland Cardiology
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Research Integrity LLC
  • Maine
    • Bangor, Maine, United States, 04401
      • Northern Light Cardiology
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Wyoming, Michigan, United States, 49519
      • Metro Health Hospital
    • Ypsilanti, Michigan, United States, 48197
      • Michigan Heart
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Mercy Clinic Heart and Vascular
    • Saint Louis, Missouri, United States, 63122
      • St. Louis Heart and Vascular
    • Saint Louis, Missouri, United States, 63128
      • Gateway Cardiovascular Research Center
    • Springfield, Missouri, United States, 65804
      • Mercy Clinic Cardiology
  • Montana
    • Kalispell, Montana, United States, 59901
      • Glacier View Research Institute Cardiology
  • New Jersey
    • Browns Mills, New Jersey, United States, 08015
      • Deborah Heart and Lung Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health
  • North Dakota
    • Fargo, North Dakota, United States, 58102
      • Sanford Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State Wexner Medical Center
    • Toledo, Ohio, United States, 43608
      • Toledo Cardiology
  • Pennsylvania
    • Newtown, Pennsylvania, United States, 18940
      • The Arrhythmia Institute
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Upstate Cardiology
    • Lancaster, South Carolina, United States, 29720
      • Carolina Heart Specialists
    • Rock Hill, South Carolina, United States, 29732
      • Carolina Cardiology Associates
  • Virginia
    • Virginia Beach, Virginia, United States, 23454
      • Cardiovascular Associates Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The subject selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 2.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'	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.	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.	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.	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.	Up to 2.5 years
Percentage of Subjects Free From Protocol Defined Adverse Events	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.	Up to 2.5 years

Collaborators and Investigators

• Sponsor: Biotronik, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 18, 2017
• Primary Completion (ACTUAL): September 27, 2019
• Study Completion (ACTUAL): September 27, 2019

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (ACTUAL): April 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Plexa Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No