The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System

  • End date
    Mar 27, 2022
  • participants needed
  • sponsor
    Abbott Medical Devices
Updated on 27 June 2021


prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.

Treatment Aveir Leadless Pacemaker System
Clinical Study IdentifierNCT04559945
SponsorAbbott Medical Devices
Last Modified on27 June 2021


Yes No Not Sure

Inclusion Criteria

Subject must have one of the clinical indications before device implant in adherence with Medicare, ACC/AHA/HRS/ESC single chamber pacing guidelines including
Chronic and/or permanent atrial fibrillation with 2 or 3 AV or bifascicular bundle branch block (BBB block), including slow ventricular rates (with or without medication) associated with atrial fibrillation; or
Normal sinus rhythm with 2 or 3 AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or
Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and
Subject is 18 years of age; and
Subject has a life expectancy of at least one year; and
Subject is not enrolled in another clinical investigation; and
Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
Subject has been informed of the nature of the study, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC; and
Subject is not pregnant and does not plan to get pregnant during the course of the study

Exclusion Criteria

Subject has known pacemaker syndrome, has retrograde VA conduction, or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or
Subject is allergic or hypersensitive to < 1 mg of dexamethasone sodium phosphate (DSP)
Subject has a mechanical tricuspid valve prosthesis; or
Subject has a pre-existing endocardial pacing or defibrillation leads; or
Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device; or
Subject has an implanted vena cava filter; or
Subject has evidence of thrombosis in one of the veins used for access during the procedure; or
Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment; or
Subject has an implanted leadless cardiac pacemaker
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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