The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System

Recruiting in Palo Alto (17 mi)

+52 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Abbott Medical Devices

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing the safety and effectiveness of the Aveir LP System, a pacemaker for patients with slow heart rhythms. The device helps the heart maintain a regular beat by sending electrical signals.

Research Team

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:

Subject is ≥18 years of age; and

Subject has a life expectancy of at least one year; and

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Exclusion Criteria

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

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