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Plexa ICD Lead Registry

NCT03103503•Biotronik, Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (28)

Thomas Hospital Research Office

Fairhope, Alabama, United States

Jeffrey S Goodman MD

Los Angeles, California, United States

Eisenhower Desert Cardiology

Rancho Mirage, California, United States

Florida Hospital

Orlando, Florida, United States

Advent Health Tampa

Tampa, Florida, United States

St. Louis Cardiology Consultants

Alton, Illinois, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Heartland Cardiology

Wichita, Kansas, United States

Research Integrity LLC

Owensboro, Kentucky, United States

Northern Light Cardiology

Bangor, Maine, United States

Key Dates

Start Date

May 18, 2017

Primary Completion Date

September 27, 2019

Completion Date

September 27, 2019

Last Updated

October 14, 2020

Enrollment

901

ACTUAL participants

Conditions

Implantable Defibrillator User

Self-Management Interventions After an ICD Shock

NCT06037785

Implantable Defibrillator UserStress Reaction+3 more

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RECRUITING

French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator

NCT03837574

Tetralogy of FallotImplantable Defibrillator User+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 14, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Plexa ICD Lead Registry

Inclusion Criteria

Exclusion Criteria

Self-Management Interventions After an ICD Shock

French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator

Scandinavian Multicenter Study to Advance Risk Stratification in Heart Disease- Ventricular Arrhythmias

Advancing Understanding of Transportation Options

Analysis of Both Sex and Device Specific Factors on Outcomes in Patients with Non-Ischemic Cardiomyopathy

Utilising Lifemap to Investigate Malignant Arrhythmia Therapy