Active — Not RecruitingNot Applicable

LEAP 2 Chronic EFS

Czechia20 participantsStarted 2025-12-13

Plain-language summary

Prospective, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIR™ Conduction System Pacing (CSP) Leadless Pacemaker system.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subject must have at least one standard pacemaker indication
✓. Subject must be at least 18 years of age
✓. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
✓. Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, as approved by the local EC

Exclusion criteria

✕. Subject has a mechanical tricuspid valve, percutaneous tricuspid valve repair or replacement, or an implanted vena cava filter
✕. Subject has evidence of tricuspid stenosis, tricuspid atresia, or presence of any condition that precludes appropriate vascular access for the study procedure
✕. Subject has previous myocardial infarction
✕. Subject is expected to be pacemaker dependent
✕. Subject has a previous or existing lead or device in the right heart or interventricular septum (includes lead fragments, temporary pacing leads, and closure devices)
✕. Subject has an active implantable electronic device that cannot be turned off during the study procedure
✕. Subject has recent cardiovascular or peripheral vascular surgery within 30 days of enrollment
✕. Subject has known allergy or hypersensitivity to \< 1 mg of dexamethasone sodium phosphate or any blood or tissue contacting material used in the study procedure

What they're measuring

Percentage of Participants Free From AVEIR CSP related Complications at 1-month

Timeframe: 1 month

Average AVEIR CSP LP Pacing Thresholds and Sense Amplitude Measurements at 1-month

Timeframe: 1 month

Trial details

NCT IDNCT07287423

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-16

View on ClinicalTrials.gov More Cardiac Pacemaker trials