Rationale and design of the Lead Evaluation for Defibrillation and Reliability study: Safety and efficacy of a novel ICD lead design

Abstract

Background: Implantable cardioverter defibrillators (ICD) are indicated for primary and secondary prevention of sudden cardiac arrest. Despite enhancements in design and technologies, the ICD lead is the most vulnerable component of the ICD system and failure of ICD leads remains a significant clinical problem. A novel, smalldiameter, lumenless, catheter-delivered, defibrillator lead was developed with the aim to improve long-term reliability. Methods and Results:The Lead Evaluation for Defibrillation and Reliability (LEADR) study is a multi-center, single-arm, Bayesian, adaptive design, pre-market interventional pivotal clinical study. Up to 60 study sites from around the world will participate in the study. Patients indicated for a de novo ICD will undergo defibrillation testing at implantation and clinical assessments at baseline, implant, pre-hospital discharge, 3 months, 6 months, and every 6 months thereafter until official study closure. Patients may be participating for a minimum of 18 months to approximately 3 years. Fracture-free survival will be evaluated using a Bayesian statistical method that incorporates both virtual patient data (combination of bench testing to failure with in-vivo use condition data) with clinical patients. The clinical subject sample size will be determined using decision rules for number of subject

Implantable Cardioverter Defibrillator Tachycardia Therapies: Past, Present and Future Directions

“…It may provide greater reliability and allow placement in more challenging and smaller anatomies, in addition to reducing chronic vascular complications and tricuspid regurgitation, which is one of the weaknesses of bulkier defibrillator leads and the use of multiple leads. An ongoing study is taking place to assess the safety and efficacy of such a design [ 174 ]. A standard defibrillator lead was successfully implanted in the left bundle branch area (LBBa) in five patients, achieving LBBa pacing and successful DFT testing [ 175 ].…”