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Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 12 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2021-06-21
Primary completion: 2025-07-31
Study completion finish: 2027-11-30
Study type
TREATMENT
Phase
NA
Trial ID
NCT04863664
Intervention or treatment
DEVICE: Defibrillation (RV Implant)
DEVICE: Defibrillation (LBBAP Implant)
Conditions
- • Tachyarrhythmia
Find a site
Closest Location:
LEADR & LEADR LBBAP: The Prince Charles Hospital
Research sites nearby
Select from list below to view details:
LEADR & LEADR LBBAP: The Prince Charles Hospital
Chermside, Queensland, Australia
LEADR: Ashford Hospital
Ashford, South Australia, Australia
LEADR: Royal Adelaide
Norwood, South Australia, Australia
LEADR &LEADR LBBAP: Canberra Hospital
Garran, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Intervention/Treatment (LEADR)
| DEVICE: Defibrillation (RV Implant)
|
EXPERIMENTAL: Intervention/Treatment (LEADR LBBAP)
| DEVICE: Defibrillation (LBBAP Implant)
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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. | 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. | 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. | 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. | Implant to 3 Months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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. | up to 24 months |
Frequently Asked Questions
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