The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiac Rhythm Disorder, Bradycardia

Intervention / Treatment
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* Device: Aveir VR Leadless Pacemaker System


Participation Criteria
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Eligibility Criteria
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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 or Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aveir VR Leadless Pacemaker<br>VVIR pacing | Device: Aveir VR Leadless Pacemaker System<br>* Patients will undergo an attempted leadless pacemaker implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication-Free Rate |  | 6 weeks | 
| Complication-Free Rate |  | 12 months | 
| Pacing thresholds and R-wave amplitudes within the therapeutic range |  | 6 Weeks | 
| Pacing thresholds and R-wave amplitudes within the therapeutic range |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appropriate and proportional rate response during graded exercise testing |  | 3 month follow up | 
| Survival Rate of Patients implanted with the Nanostim Leadless Pacemaker |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bradycardia, Pacemaker, Leadless