Clinical trial NCT03103503: Plexa ICD Lead Registry
Official title: Plexa ICD Lead Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Implantable Defibrillator User
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-06
Enrollment: 901
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Subjects Free From Plexa Lead Related Adverse Events
timeFrame: Up to 2.5 years
Secondary outcomes:
measure: Plexa Lead Safety-Individual Adverse Events
timeFrame: Up to 2.5 years
measure: Pacing Threshold Measurements for the Plexa Lead Through Study Termination
timeFrame: Up to 2.5 years
measure: Sensing Measurements for the Plexa Lead Through Study Termination
timeFrame: Up to 2.5 years
measure: Pacing Impedance Measurements for the Plexa Lead Through Study Termination
timeFrame: Up to 2.5 years
measure: Shock Impedance for the Plexa Lead Through Study Termination
timeFrame: Up to 2.5 years
measure: Percentage of Subjects Free From Protocol Defined Adverse Events
timeFrame: Up to 2.5 years
Other outcomes:
Locations:
city: Fairhope
country: United States
facility: Thomas Hospital Research Office
state: Alabama
city: Los Angeles
country: United States
facility: Jeffrey S Goodman MD
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Desert Cardiology
state: California
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Tampa
country: United States
facility: Advent Health Tampa
state: Florida
city: Alton
country: United States
facility: St. Louis Cardiology Consultants
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Wichita
country: United States
facility: Heartland Cardiology
state: Kansas
city: Owensboro
country: United States
facility: Research Integrity LLC
state: Kentucky
city: Bangor
country: United States
facility: Northern Light Cardiology
state: Maine
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Wyoming
country: United States
facility: Metro Health Hospital
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Saint Louis
country: United States
facility: St. Louis Heart and Vascular
state: Missouri
city: Saint Louis
country: United States
facility: Gateway Cardiovascular Research Center
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Clinic Heart and Vascular
state: Missouri
city: Springfield
country: United States
facility: Mercy Clinic Cardiology
state: Missouri
city: Kalispell
country: United States
facility: Glacier View Research Institute Cardiology
state: Montana
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Winston-Salem
country: United States
facility: Novant Health
state: North Carolina
city: Fargo
country: United States
facility: Sanford Medical Center
state: North Dakota
city: Columbus
country: United States
facility: The Ohio State Wexner Medical Center
state: Ohio
city: Toledo
country: United States
facility: Toledo Cardiology
state: Ohio
city: Newtown
country: United States
facility: The Arrhythmia Institute
state: Pennsylvania
city: Greenville
country: United States
facility: Upstate Cardiology
state: South Carolina
city: Lancaster
country: United States
facility: Carolina Heart Specialists
state: South Carolina
city: Rock Hill
country: United States
facility: Carolina Cardiology Associates
state: South Carolina
city: Virginia Beach
country: United States
facility: Cardiovascular Associates Ltd
state: Virginia
Study officials:
References: