N/A
N=324
The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System
Cardiac Rhythm Disorder · Bradycardia
Bottom Line
View on ClinicalTrials.gov: NCT04559945 ↗Enrolled (actual)
324
Serious AEs
30.3%
Results posted
May 2026
Primary outcome: Primary: Complication-Free Rate (CFR) — 96.0 percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aveir VR Leadless Pacemaker System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complication-Free Rate (CFR) |
93.2 | <0.0001 sig |
| PRIMARY Complication-Free Rate (CFR) |
93.2 | <0.0001 sig |
| PRIMARY Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range |
95.1 | <0.0001 sig |
| PRIMARY Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range |
95.1 | <0.0001 sig |
| SECONDARY Appropriate and Proportional Rate Response During Graded Exercise Testing |
0.93 | 0.001 sig |
| SECONDARY Survival Rate of Patients Implanted With the Nanostim Leadless Pacemaker |
85.3 | <0.0001 sig |
Summary
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT04559945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.