Munson Medical Center | Cancer Research Department
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About
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.
Enrollment
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Volunteers
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
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
Primary purpose
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Interventional model
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326 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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