Lead EvaluAtion for Defibrillation and Reliability (LEADR)

  • STATUS
    Recruiting
  • End date
    Apr 30, 2024
  • participants needed
    500
  • sponsor
    Medtronic Cardiac Rhythm and Heart Failure
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Updated on 23 October 2022
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Summary

The study is designed to assess the safety and efficacy of the Next Generation ICD lead.

Description

The study will enroll subjects who are indicated to receive an implantable single or dual chamber ICD, or CRT-D and who meet all of the inclusion criteria and none of the exclusion criteria. Subjects will receive an investigational Next Generation ICD Lead. Subjects will be followed for at least 18 months following Next Generation ICD Lead implantation.

Details
Condition Tachyarrhythmia
Treatment Defibrillation
Clinical Study IdentifierNCT04863664
SponsorMedtronic Cardiac Rhythm and Heart Failure
Last Modified on23 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subject meets current clinical practice guidelines for implantation of ICD or CRT-D and will undergo one of the following
de novo Medtronic CRT-D system implant
de novo Medtronic ICD system implant (single or dual chamber)
Subject has, per local law and requirements, the minimum age for autonomously signing
Subject is willing to undergo implant defibrillation testing if requested
an ICF
Subject is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up

Exclusion Criteria

Subject is unwilling or unable to personally provide Informed Consent
Subject has contraindications for standard RV transvenous lead placement (e.g., mechanical right heart valve)
Subject has a life expectancy of less than 12 months
Subject is contraindicated for ≤1 mg dexamethasone acetate
For subject undergoing defibrillation testing the following medical conditions exclude
them
Pre-existing or suspected pneumothorax during implant
Current intracardiac left atrial or left ventricular (LV) thrombus
Severe aortic stenosis
Severe proximal three-vessel or left main coronary artery disease without revascularization
Unstable angina
Ejection Fraction less than 25%
Recent stroke or transient ischemic attack (within the last 6 months)
Known inadequate external defibrillation
Any other known medical condition not listed that precludes their participation in the opinion of the investigator
Subject with any exclusion criteria as required by local law (e.g., age or other)
Subject is enrolled or planning to enroll in a concurrent clinical study that may
Pregnant women or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence
confound the results of this study, without documented pre-approval from a
Subject with an existing pacemaker (including transcatheter pacing system), ICD, or CRT device or leads
Medtronic study manager
Subject with any evidence of active infection or undergoing treatment for an infection
Recent (or planned) cardiac surgery or stenting less than 1 month before implant
End stage renal disease
Subjects with NYHA IV classification
Subjects with a transplanted heart
Subjects with previously extracted leads
Subjects with Left Ventricular Assist Device
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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