Plexa ICD Lead Registry

Implantable Defibrillator User Clinical Trial

Official title:

Plexa ICD Lead Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03103503
• Other study ID #: Plexa Registry
• Status: Terminated
• Start date: May 18, 2017
• Est. completion date: September 27, 2019

Study information

• Verified date: September 2020
• Source: Biotronik, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 901
• Est. completion date: September 27, 2019
• Est. primary completion date: September 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Implantable Defibrillator User

Locations

Country	Name	City	State
United States	St. Louis Cardiology Consultants	Alton	Illinois
United States	University of Michigan	Ann Arbor	Michigan
United States	Northern Light Cardiology	Bangor	Maine
United States	Deborah Heart and Lung Center	Browns Mills	New Jersey
United States	The Ohio State Wexner Medical Center	Columbus	Ohio
United States	Thomas Hospital Research Office	Fairhope	Alabama
United States	Sanford Medical Center	Fargo	North Dakota
United States	Upstate Cardiology	Greenville	South Carolina
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Glacier View Research Institute Cardiology	Kalispell	Montana
United States	Carolina Heart Specialists	Lancaster	South Carolina
United States	Jeffrey S Goodman MD	Los Angeles	California
United States	The Arrhythmia Institute	Newtown	Pennsylvania
United States	Florida Hospital	Orlando	Florida
United States	Research Integrity LLC	Owensboro	Kentucky
United States	Eisenhower Desert Cardiology	Rancho Mirage	California
United States	Carolina Cardiology Associates	Rock Hill	South Carolina
United States	Gateway Cardiovascular Research Center	Saint Louis	Missouri
United States	Mercy Clinic Heart and Vascular	Saint Louis	Missouri
United States	St. Louis Heart and Vascular	Saint Louis	Missouri
United States	Mercy Clinic Cardiology	Springfield	Missouri
United States	Advent Health Tampa	Tampa	Florida
United States	Toledo Cardiology	Toledo	Ohio
United States	Cardiovascular Associates Ltd	Virginia Beach	Virginia
United States	Heartland Cardiology	Wichita	Kansas
United States	Novant Health	Winston-Salem	North Carolina
United States	Metro Health Hospital	Wyoming	Michigan
United States	Michigan Heart	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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