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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P240036 / PAS001 |
| Date Original Protocol Accepted |
04/22/2025
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| Date Current Protocol Accepted |
04/24/2026
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| Study Name |
LEADR PAS
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| Device Name |
OmniaSecure™ MRI SureScan™ Lead Model 3930M
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| Clinical Trial Number(s) |
NCT04863664
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
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| Comparison Group |
No Control
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| Analysis Type |
Analytical
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| Study Population |
Adolescent: 13-18 yrs,
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of this study is to characterize the long-term safety and estimate the lead-related complication-free survival of the Model 3930M Lead using registry data (Product Surveillance Registry)
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| Study Population |
Adolescent pediatric (>12 years old) and adults.
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| Sample Size |
Approximately up to 2000 patients will be enrolled into LEADR PAS across an estimated 250 active PSR global sites where the Model 3930M is commercially available. Dependent on market approval, participating geographies may include, but are not limited to, US/Canada, EMEA, APAC, SEA, and Greater China.
125 adolescent pediatric patients will be enrolled and included within the total patient enrollment count. Approximately 5 pediatric specific sites are planned to be added to the PSR to support enrollment of this population.
A minimum of 339 patients with LBBA placement will be included in the total patients enrollment count who have completed 5 years of follow up at the time of final analysis.
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| Key Study Endpoints |
Primary Objective: Estimate Model 3930M Lead-related complication-free survival through five (5) years post implant. For an adverse event to meet the endpoint, defined as a first occurrence of a complication related to the Model 3930M Lead of an enrolled patient as determined by the CEC, the event must have occurred within five (5) years post-lead implant and be adjudicated by the CEC as being a complication related to the lead.
a. The following complications will be included in the analysis:
i. Failure to capture
ii. Failure to sense/undersensing
iii. Oversensing
iv. Elevated threshold
v. Abnormal pacing/defibrillation impedance
vi. Lead insulation breach
vii. Lead conductor fracture
viii. Extracardiac Stimulation
ix. Lead migration/dislodgement
x. Cardiac perforation
xi. Lead structural failure
xii. Erosion/extrusion
xiii. Infection
xiv. Transvenous lead-related thrombosis
Ancillary objectives will include the following:
1. Summarize patient demographics
2. Summarize Model 3930M Lead-related adverse events
3. Summarize patient deaths
4. Summarize all Model 3930M Lead system modifications
5. Summarize Model 3930M Lead electrical performance
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| Follow-up Visits and Length of Follow-up |
The study will complete when approximately 500 patients have completed 5 years of follow-up. The total estimated PAS duration is 7 years.
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