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Plexa ICD Lead Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103503
Recruitment Status : Terminated (Collection of long term lead performance is being transferred to an alternate data collection methodology.)
First Posted : April 6, 2017
Results First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.

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

Condition or disease
Implantable Defibrillator User

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Study Type : Observational [Patient Registry]
Actual Enrollment : 901 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Plexa ICD Lead Registry
Actual Study Start Date : May 18, 2017
Actual Primary Completion Date : September 27, 2019
Actual Study Completion Date : September 27, 2019



Primary Outcome Measures :
  1. Percentage of Subjects Free From Plexa Lead Related Adverse Events [ Time Frame: Up to 2.5 years ]
    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.


Secondary Outcome Measures :
  1. Plexa Lead Safety-Individual Adverse Events [ Time Frame: Up to 2.5 years ]
    Evaluate the individual types of adverse events contributing to primary outcome measure 'Percentage of Subjects Free From Plexa Lead Related Adverse Events'

  2. Pacing Threshold Measurements for the Plexa Lead Through Study Termination [ Time Frame: Up to 2.5 years ]
    Pacing threshold measurements at pulse width of 0.4 for the Plexa leads at completed follow-up visits.

  3. Sensing Measurements for the Plexa Lead Through Study Termination [ Time Frame: Up to 2.5 years ]
    Sensing measurements for the Plexa leads at completed follow-up visits.

  4. Pacing Impedance Measurements for the Plexa Lead Through Study Termination [ Time Frame: Up to 2.5 years ]
    Pacing impedance measurements for the Plexa leads at completed follow-up visits.

  5. Shock Impedance for the Plexa Lead Through Study Termination [ Time Frame: Up to 2.5 years ]
    Shock impedance measurements for the Plexa leads at completed follow-up visits.

  6. Percentage of Subjects Free From Protocol Defined Adverse Events [ Time Frame: Up to 2.5 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103503


Locations
Show Show 28 study locations
Sponsors and Collaborators
Biotronik, Inc.
  Study Documents (Full-Text)

Documents provided by Biotronik, Inc.:
Additional Information:

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Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT03103503    
Other Study ID Numbers: Plexa Registry
First Posted: April 6, 2017    Key Record Dates
Results First Posted: October 14, 2020
Last Update Posted: October 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No