Lead EvaluAtion for Defibrillation and Reliability (LEADR)

Study Overview
=================
Brief Summary
-----------------
The study is designed to assess the safety and efficacy of the Next Generation ICD lead.

Detailed 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.

Official Title
-----------------
Lead EvaluAtion for Defibrillation and Reliability (LEADR)

Conditions
-----------------
Tachyarrhythmia

Intervention / Treatment
-----------------
* Device: Defibrillation


Participation Criteria
=================
Eligibility Criteria
-----------------
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 an ICF Subject is willing to undergo implant defibrillation testing if requested. 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 is contraindicated for ≤1 mg dexamethasone acetate. Subject has a life expectancy of less than 12 months 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 is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager. Subject with any exclusion criteria as required by local law (e.g., age or other). Pregnant women or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence Subject with an existing pacemaker (including transcatheter pacing system), ICD, or CRT device or leads 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention/Treatment<br>Patients will be implanted with a Next Generation ICD Lead and undergo required electrical testing | Device: Defibrillation<br>* Required electrical testing for pacing, sensing, impedance and defibrillation will be completed<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the rate of major Lead complication-free rate at 6 months | Subjects free of Next Generation ICD lead-related complication at 6 months post-implant. | Implant to 6 Months | 
| Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead | Defibrillation testing will be completed in a subset of subjects at implant. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the fracture-free rate of the Next Generation ICD lead | Subjects will be assessed at certain time points for Next Generation ICD lead fracture related to the Next Generation ICD lead. | up to 24 months |