The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 1,276
- Locations
- 93
- Primary Endpoint
- Complication-Free Rate
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Aveir VR Leadless Pacemaker
VVIR pacing
Intervention: Aveir VR Leadless Pacemaker System (Device)
Outcomes
Primary Outcomes
Complication-Free Rate
Time Frame: 12 months
Pacing thresholds and R-wave amplitudes within the therapeutic range
Time Frame: 12 months
Complication-Free Rate (CFR)
Time Frame: 6 weeks
Complication is any device-or-procedure related serious adverse event, or serious adverse device effect, including those that prevented initial implantation. Complications possibly related or related to COVID-19 were excluded. Percentage of participants free from complications are reported
Complication-Free Rate (CFR)
Time Frame: 12 months
Complication is any device-or-procedure related serious adverse event, or serious adverse device effect, including those that prevented initial implantation. Complications possibly related or related to COVID-19 were excluded. The complication free rate reported describes the Kaplan-Meier estimate of the percentage of patients that had no complications at the given time point.
Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range
Time Frame: 6 Weeks (Aveir VR Leadless Pacemaker arm)
Success Rate is percentage of subjects who have acceptable pacing threshold and sensing amplitudes, which are defined as pacing threshold \<=2.0V at 0.4 ms pulse width and R-wave amplitude =\>5.0 mV or =\> value at implant.
Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range
Time Frame: 12 months
Success Rate is percentage of subjects who have acceptable pacing threshold and sensing amplitudes at 12-Month post-implant visit, which are defined as pacing threshold \<=2.0V at 0.4 ms pulse width and R-wave amplitude =\>5.0 mV or =\> value at implant.
Secondary Outcomes
- Survival Rate of Patients implanted with the Nanostim Leadless Pacemaker(2 years)
- Appropriate and proportional rate response during graded exercise testing(3 month follow up)
- 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)