Plexa ICD Lead Registry

NCT03103503 | Terminated Results

• 1 other identifier: Plexa Registry
• Study Type: observational
• Target: 901
• Locations: 1 country
• Sites: 28

Brief Summary

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

Conditions

Implantable Defibrillator User

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Plexa Lead Safety-Individual Adverse Events

  Up to 2.5 years

• Pacing Threshold Measurements for the Plexa Lead Through Study Termination

  Up to 2.5 years

• Sensing Measurements for the Plexa Lead Through Study Termination

  Up to 2.5 years

• Pacing Impedance Measurements for the Plexa Lead Through Study Termination

  Up to 2.5 years

• Shock Impedance for the Plexa Lead Through Study Termination

  Up to 2.5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik, Inc.: lead

Study Sites (28)

Thomas Hospital Research Office

Fairhope, Alabama, 36532, United States

Location

Jeffrey S Goodman MD

Los Angeles, California, 90048, United States

Location

Eisenhower Desert Cardiology

Rancho Mirage, California, 92270, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Advent Health Tampa

Tampa, Florida, 33613, United States

Location

St. Louis Cardiology Consultants

Alton, Illinois, 62002, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Heartland Cardiology

Wichita, Kansas, 67205, United States

Location

Research Integrity LLC

Owensboro, Kentucky, 42303, United States

Location

Northern Light Cardiology

Bangor, Maine, 04401, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Metro Health Hospital

Wyoming, Michigan, 49519, United States

Location

Michigan Heart

Ypsilanti, Michigan, 48197, United States

Location

Mercy Clinic Cardiology

Springfield, Missouri, 65804, United States

Location

St. Louis Heart and Vascular

St Louis, Missouri, 63122, United States

Location

Gateway Cardiovascular Research Center

St Louis, Missouri, 63128, United States

Location

Mercy Clinic Heart and Vascular

St Louis, Missouri, 63141, United States

Location

Glacier View Research Institute Cardiology

Kalispell, Montana, 59901, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Novant Health

Winston-Salem, North Carolina, 27103, United States

Location

Sanford Medical Center

Fargo, North Dakota, 58102, United States

Location

The Ohio State Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Toledo Cardiology

Toledo, Ohio, 43608, United States

Location

The Arrhythmia Institute

Newtown, Pennsylvania, 18940, United States

Location

Upstate Cardiology

Greenville, South Carolina, 29607, United States

Location

Carolina Heart Specialists

Lancaster, South Carolina, 29720, United States

Location

Carolina Cardiology Associates

Rock Hill, South Carolina, 29732, United States

Location

Cardiovascular Associates Ltd

Virginia Beach, Virginia, 23454, United States

Location

Results Point of Contact

• Title: Clinical Studies Engineer Manager
• Organization: BIOTRONIK

crystal.miller@biotronik.com

800-547-0394

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 6, 2017
• Study Start: May 18, 2017
• Primary Completion: September 27, 2019
• Study Completion: September 27, 2019
• Last Updated: October 14, 2020
• Results First Posted: October 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (28)