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. 2023 Feb;34(2):257-267.
doi: 10.1111/jce.15747. Epub 2023 Jan 8.

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

George H Crossley  1 , Prashanthan Sanders  2 , Paolo De Filippo  3 , Khaldoun G Tarakji  4 , Bert Hansky  5 , Maully Shah  6 , Pamela Mason  7 , Baerbel Maus  8 , Keith Holloman  9
Affiliations

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

George H Crossley et al. J Cardiovasc Electrophysiol. 2023 Feb.

Erratum in

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, small-diameter, 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 enrollments and follow-up time based upon the observed number of fractures at certain time points in the study. The adaptive study design will therefore result in a minimum of 500 and a maximum of 900 patients enrolled.

Conclusion: The LEADR Clinical Study was designed to efficiently provide evidence for short- and long-term safety and efficacy of a novel lead design using Bayesian methods including a novel virtual patient approach.

Keywords: adaptive design; defibrillation lead; virtual patient modeling.

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Figures

Figure 1
Figure 1
Cross‐sectional comparison of Sprint Quattro Model 6947M, LEADR ICD, and SelectSecure Model 3830 leads. Lead diameter is shown below each lead. Note that the LEADR Lead has thicker outer insulation. Fr, French; ICD, implantable cardioverter defibrillator.
Figure 2
Figure 2
Diagram outlining the process of SSVA induction and defibrillation testing. Depiction of the schematic for defibrillation testing. For defibrillation success, a patient will need to have successful conversion of a single induced sustained shockable ventricular arrhythmia (SSVA) by an 18 J shock or successful conversion of two consecutive induced SSVAs at 25 Joules.
Figure 3
Figure 3
Overview of the LEADR Clinical Study. Study flow diagram. AE, adverse event; ICD, implantable cardioverter defibrillator; PHD, pre‐hospital discharge.
Figure 4
Figure 4
Bayesian and adaptive design combines virtual + clinical patients for analysis of conductor fractures. The Bayesian and adaptive study design is shown for both the clinical and virtual patient cohorts. DFT, defibrillation testing.
See this image and copyright information in PMC

Comment in

  • The LEADR ICD lead study: Is thinner better?
    Anderson C, Olshansky B. Anderson C, et al. J Cardiovasc Electrophysiol. 2023 Feb;34(2):268-269. doi: 10.1111/jce.15750. Epub 2022 Nov 15. J Cardiovasc Electrophysiol. 2023. PMID: 36378785 No abstract available.

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