The LEADR study is designed to assess the safety and efficacy of the Next Generation ICD lead. The LEADR LBBAP study is being conducted under the existing US FDA Investigational Device Exemption (IDE) for the Next Generation ICD Lead and is designed to confirm the safety and defibrillation efficacy of the Next Generation ICD Lead when placed in the LBBAP location in ICD and LOT-CRT patient population.
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LEADR: Estimate the rate of major Lead complication-free rate at 6 months
Timeframe: Implant to 6 Months
LEADR: Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead
Timeframe: Day 1
LEADR LBBAP: Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead
Timeframe: Day 1
LEADR LBBAP: The lead-related major complication rate at 3-months
Timeframe: Implant to 3 Months