Leadless II Study

General Information Age Group Adults Status Recruiting Protocol Number NCT02030418, IDE number G130138 Background Information Phase 2 of this 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. Sponsor will conduct the study at up to 80 centers worldwide that contributed enrollments to Phase 1 of this IDE study or contributed enrollments in the Leadless Observational Study in Europe. The Sponsor expects to enroll up to 200 newly implanted (de novo) subjects. Offered At Inova Fairfax Hospital 3300 Gallows Rd. Falls Church, VA 22042 Principal Investigator Marc Wish, MD Eligibility Information Subjects who are at least 18 years of age at the time of informed consent Subject must have one of the clinical indications before device implant in adherence with Medicare, ACC/AHA/HRS/ESC guidelines: Chronic and/ or permanent atrial fibrillation with 2 or 3 degree AV block Sinus Bradycardia with infrequent pauses or unexplained syncope with EP findings Subject is not pregnant Ineligibility Information Subject has known pacemaker syndrome, has retrograde VA conduction, or suffers aa drop in arterial blood pressure with the onset of ventricular pacing Subject is allergic or hypersensitive to < 1 mg of dexamethasone sodium phosphate Subject has a mechanical tricuspid valve prosthesis Subject has pre-existing endocardial pacing defibrillation leads Contact Information Contact Name Tracy Plummer Contact Phone 703-776-3567 Contact Email Send Email