NCT04863664

Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 998 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The LEADR and LEADR LBBAP studies will enroll subjects who are indicated to receive an implantable single or dual chamber ICD, or CRT-D, and who meet all of the inclusion criteria and none of the exclusion criteria. Subjects will receive an investigational Next Generation ICD Lead. Subjects in the LEADR study will be followed for at least 18 months following Next Generation ICD Lead implantation in a septal (non-LBBAP) or apical implant location. Enrollment in the LEADR study has been completed (675 subjects enrolled). Subjects in the LEADR LBBAP study will be followed for at least 3 months (ICD-indicated subjects) or 6 months (CRT-indicated subjects) following Next Generation ICD Lead implantation in an LBBAP implant location. Enrollment in the LEADR LBBAP study has been completed (323 subjects enrolled).

Conditions

• Tachyarrhythmia

Interventions

Type	Name	Description
DEVICE	Defibrillation (RV Implant)	Required electrical testing for pacing, sensing, impedance and defibrillation will be completed
DEVICE	Defibrillation (LBBAP Implant)	Required electrical testing for pacing, sensing, impedance and defibrillation will be completed

Timeline

• Start date: 2021-06-21
• Primary completion: 2025-09-03
• Completion: 2025-11-06
• First posted: 2021-04-28
• Last updated: 2025-12-09

Locations

55 sites across 20 countries: United States, Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Japan, Malaysia, Netherlands, Poland, Portugal, Serbia, Singapore, Spain, United Kingdom

Regulatory

• FDA-regulated device study