Clinical Trial: BIO|CONCEPT.Amvia Study
Study Status: COMPLETED
Recruit Status: COMPLETED
Condition: Bradycardia
Study Type: INTERVENTIONAL
Official Title: BIO|CONCEPT.Amvia, First in Human Study for the Amvia/Solvia Pacemaker Family
Brief Summary:
The goal of this exploratory study is to test the preliminary safety and product performance of the new Amvia/Solvia pacemaker family in subjects that require a pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation.The study will be conducted at sites in Australia and New Zealand.It is planned to include 50 subjects in the study.Participants will visit sites at enrollment in the study, at implantation, pre-hospital discharge, 1- 3- and 12-month follow-up visits.At the visits the device…
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