TerminatedNot Applicable

Plexa ICD Lead Registry

Stopped: Collection of long term lead performance is being transferred to an alternate data collection methodology.

United States901 participantsStarted 2017-05-18

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Subjects Free From Plexa Lead Related Adverse Events

Timeframe: Up to 2.5 years

Trial details

NCT IDNCT03103503

SponsorBiotronik, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-09-27

Results submitted2020-08-25

View on ClinicalTrials.gov More Implantable Defibrillator User trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.