The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker

Study Overview
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Brief Summary
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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.

Detailed Description
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The purpose of this study is to evaluate the safety and effectiveness of the leadless pacemaker system in treating patients with a slow heart rate or irregular heartbeats. The Nanostim leadless pacemaker provides bradycardia pacing as a pulse generator with built-in battery and electrodes, for permanent implantation in the right ventricle. As a leadless pacemaker, it does not need a connector, pacing lead, or pulse generator pocket, but it has the same operating principles as a conventional pacemaker.

Official Title
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The LEADLESS II IDE Study (Phase I): Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker

Conditions
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Bradycardia

Intervention / Treatment
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* Device: Leadless Pacemaker


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 ≥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

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: Leadless Pacemaker<br>VVIR pacing | Device: Leadless Pacemaker<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 months | 
| Pacing thresholds and R-wave amplitudes within the therapeutic range |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| appropriate and proportional rate response during graded exercise testing |  | 3-6 months |