Tachyarrhythmia
Conditions
Brief 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).
Interventions
DEVICEDefibrillation (RV Implant)
Required electrical testing for pacing, sensing, impedance and defibrillation will be completed
DEVICEDefibrillation (LBBAP Implant)
Required electrical testing for pacing, sensing, impedance and defibrillation will be completed
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
LEADR Inclusion Criteria: * Subject meets current clinical practice guidelines for implantation of ICD or CRT-D and will undergo one of the following: * de novo Medtronic CRT-D system implant * de novo Medtronic ICD system implant (single or dual chamber) * Subject has, per local law and requirements, the minimum age for autonomously signing an ICF (minimum age of 18 years) * Subject is willing to undergo implant defibrillation testing if requested. * Subject is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up. LEADR
Exclusion criteria
* Subject is unwilling or unable to personally provide Informed Consent. * Subject has contraindications for standard RV transvenous lead placement (e.g., mechanical right heart valve). * Subject is contraindicated for ≤1 mg dexamethasone acetate. * Subject has a life expectancy of less than 12 months * For subject undergoing defibrillation testing the following medical conditions exclude them: * Pre-existing or suspected pneumothorax during implant * Current intracardiac left atrial or left ventricular (LV) thrombus * Severe aortic stenosis * Severe proximal three-vessel or left main coronary artery disease without revascularization * Unstable angina * Ejection Fraction less than 25% * Recent stroke or transient ischemic attack (within the last 6 months) * Known inadequate external defibrillation * Any other known medical condition not listed that precludes their participation in the opinion of the investigator * Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager. * Subject with any
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LEADR: Estimate the rate of major Lead complication-free rate at 6 months | Implant to 6 Months | Subjects free of Next Generation ICD lead-related complication at 6 months post-implant. |
| LEADR: Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead | Day 1 | Defibrillation testing will be completed in a subset of subjects at implant. |
| LEADR LBBAP: Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead | Day 1 | Defibrillation testing will be completed with the Next Generation ICD Lead in the LBBAP location in a subset of subjects at implant. |
| LEADR LBBAP: The lead-related major complication rate at 3-months | Implant to 3 Months | Subjects free of Next Generation ICD lead-related complication at 3 months post-implant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LEADR: Estimate the fracture-free rate of the Next Generation ICD lead | up to 24 months | Subjects will be assessed at certain time points for Next Generation ICD lead fracture related to the Next Generation ICD lead. |
Countries
Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Japan, Malaysia, Netherlands, Poland, Portugal, Serbia, Singapore, Spain, United Kingdom, United States
Outcome results
None listed