NCT07005232
Lead Evaluation for Defibrillation and Reliability Post Approval Study
Enrolling by Invitation
Not specifiedAll AgesObservationalMedtronic
~2,000 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:defibrillation lead
At a glance
Recruiting sites
0 of 73 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complication Survival Rate
Measured over 5 years
Conditions
Where it's being run
73 sites across 32 statesFrance8
Florida5
Minnesota5
New York5
Pennsylvania4
Spain4
Missouri3
Ohio3
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
Patient has, or is intended to receive or be treated with an OmniaSecure™ defibrillation lead.
Patient is consented prior to or within 30 days of the therapy received or consented as continuation from the LEADR Pivotal study
Exclusion
Patient who is, or is expected to be, inaccessible for follow-up
Patient is excluded by local local law
Patient is currently enrolled or plans to enroll in any concurrent drug and/or device study that may confound the Product Surveillence Registyr (PSR) results
What this trial measures
- Complication Survival Rate5 years
Estimate OmniaSecure lead-related complication-free survival through 5 years post implant.