N/A
Completed N=952
The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker
Bradycardia
Source: ClinicalTrials.gov NCT02030418 ↗
Enrolled (actual)
952
Serious AEs
45.8%
Results posted
Jul 2025
Primary outcomePrimary: Complication-Free Rate — 93.3 percentage of participants — p=<0.001
Summary
Prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR pacemaker.
Following completion of enrollments in the IDE, patients will continue to be enrolled in the continued access phase of the study under the same protocol.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complication-Free Rate |
93.3 | <0.001 sig |
| PRIMARY Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range |
93.4 | <0.001 sig |
| SECONDARY Appropriate and Proportional Rate Response During Graded Exercise Testing |
0.83 | 0.001 sig |
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 ≥18 years of age; and
- Subject has 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 written informed consent, approved by the IRB; and
- Subject is not pregnant and does not plan to get pregnant during the course of the study.
Exclusion Criteria
- Subject has 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; or
- 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); 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 has an implanted leadless cardiac pacemaker; or
- Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment
Data sourced from ClinicalTrials.gov (NCT02030418). 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. Informational only — not medical advice.