Lead EvaluAtion for Defibrillation and Reliability (LEADR)
The number of patients recruited by Canberra Heart Rhythm: 24
Prospective, multi-center, single-arm, nonrandomized, Bayesian, adaptive study design, pre-market, interventional pivotal clinical study.
SYNOPSIS OF THE STUDY:
The expected total study duration is approximately 3 years from the study’s first enrollment.
The enrollment period is expected to take approximately 15 months.
Individual subjects may be participating in the study for a period of minimum 18 months to approximately 3 years. Subjects will undergo assessments at baseline, implant, pre-hospital discharge, 3 months, 6 months, and every 6 months thereafter until official study closure.
The number of enrolled subjects in the study may vary from 500 to 900 subjects depending on the number of fractures observed during the study and on the number of implants.
Maximum number of subjects enrolled at each site will be capped at 25 (5% of minimum number of enrollments (500)). If the sample size is increased by a certain number of patients based on the adaptive study
design, the enrollment cap will increase by 10% of the sample size increase.
Primary Safety Objective: Demonstrate that the freedom from major complications related to the Next Generation ICD lead at 6 months postimplant exceeds a pre-specified threshold of 90%.
The endpoint is defined as a subject’s first occurrence of a major complication related to the Next Generation ICD lead, as determined by an independent Clinical Events Committee (CEC), the event must have occurred within 182 days (inclusive) of the Next Generation ICD lead implant attempt.
Primary Efficacy Objective: Demonstrate the percentage of patients successfully defibrillated at implant with the Next Generation ICD lead exceeds a prespecified threshold of 88%.
Inclusion Criteria
1. Subject meets current clinical practice guidelines for ICD or CRT-D implantation and will undergo one of the following:
• de novo Medtronic CRT-D system implant
• de novo Medtronic ICD system implant (single or dual chamber)
2. Subject has, per local law and requirements, the minimum age for autonomously signing an ICF
3. Subject is willing to undergo implant defibrillation testing if requested.
4. Subject is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up.
Exclusion Criteria
1. Subject is unwilling or unable to personally provide Informed Consent.
2. Subject has contraindications for standard RV transvenous lead placement (e.g., mechanical right heart valve).
3. Subject is contraindicated for ≤1 mg dexamethasone acetate.
4. Subject has a life expectancy of less than 12 months.
5. Subject is unable to undergo defibrillation testing due to physician judgement or medical conditions such as
• 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
6. 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.
7. Subject with any exclusion criteria as required by local law (e.g., age or other).
8. Pregnant women or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence.
9. Subject with an existing pacemaker (including transcatheter pacing system), ICD, or CRT device or leads.
10. Subject with any evidence of active infection or undergoing treatment for an infection.
11. Recent (or planned) cardiac surgery or stenting less than 1 month before implant.
12. End stage renal disease.
13. Subjects with NYHA IV classification.
14. Subjects with a transplanted heart.
15. Subjects with a history of extracted leads.
16. Subjects with Left Ventricular Assist Device.