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.
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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