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.
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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
998
Required electrical testing for pacing, sensing, impedance and defibrillation will be completed
Required electrical testing for pacing, sensing, impedance and defibrillation will be completed
LEADR: Estimate the rate of major Lead complication-free rate at 6 months
Subjects free of Next Generation ICD lead-related complication at 6 months post-implant.
Time frame: Implant to 6 Months
LEADR: Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead
Defibrillation testing will be completed in a subset of subjects at implant.
Time frame: Day 1
LEADR LBBAP: Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead
Defibrillation testing will be completed with the Next Generation ICD Lead in the LBBAP location in a subset of subjects at implant.
Time frame: Day 1
LEADR LBBAP: The lead-related major complication rate at 3-months
Subjects free of Next Generation ICD lead-related complication at 3 months post-implant.
Time frame: Implant to 3 Months
LEADR: Estimate the fracture-free rate of the Next Generation ICD lead
Subjects will be assessed at certain time points for Next Generation ICD lead fracture related to the Next Generation ICD lead.
Time frame: up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
LEADR: Heart Center Research
Huntsville, Alabama, United States
LEADR LBBAP: Torrance Memorial Medical Center
Torrance, California, United States
LEADR: Hartford Hospital
Hartford, Connecticut, United States
LEADR: University of South Florida
Tampa, Florida, United States
LEADR & LEADR LBBAP: Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
LEADR: Saint Luke's Mid America Heart Institute
Kansas City, Missouri, United States
LEADR: Washington University School of Medicine
St Louis, Missouri, United States
LEADR: Lourdes Cardiology Services
Voorhees Township, New Jersey, United States
LEADR: Presbyterian Heart Group
Albuquerque, New Mexico, United States
LEADR & LEADR LBBAP: South Shore University Hospital/Northwell Health
Bay Shore, New York, United States
...and 45 more locations