The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).
This CED study utilizes a real-world evidence (RWE) method merging multiple real-world datasets from Abbott and the Center for Medicare Services to assess Aveir DR LP health outcomes among Medicare beneficiaries. The study will enroll all Medicare patients with continuous claims data implanted with the Aveir DR LP system or a dual-chamber transvenous pacemaker system from any manufacturer. Due to the RWE data collection methods used in this study, a central institutional review board (IRB) approved informed consent waiver has been granted. Due to this waiver and the sponsor's use of the central IRB, individual hospitals are not required to consent patients or complete local IRB submissions for this RWE study.
Study Type
OBSERVATIONAL
Enrollment
2,812
This study will utilize real-world data from patients implanted with the Aveir DR Leadless Pacemaker System. No device intervention is required in this study.
This study will utilize real-world data from patients implanted with a dual-chamber transvenous pacemaker as a comparator to the Aveir DR LP system study arm. No device intervention is required in this study.
Abbott
Sylmar, California, United States
RECRUITINGAcute device related complication rate
Assess the acute (30-day) complication rate of the Aveir DR LP, compared to dual chamber transvenous pacemakers. An acute complication is defined as a peri-procedural, device-related adverse event occurring within 30 days post-implant.
Time frame: 30 days
Two-year survival rate
Assess (2-year) survival rate of subjects implanted with an Aveir DR LP, compared to dual chamber transvenous pacemakers.
Time frame: 2 years
Chronic complication rate
Assess the chronic (6-month) complication rate of the Aveir DR LP, compared to dual chamber transvenous pacemakers. A chronic complication is defined as a post-procedural, device-related adverse event that requires invasive intervention to resolve, occurring more than 30 days through six months post implant.
Time frame: 6 months
Device-related re-intervention rates
Assess (2-year) device-related re-intervention rates of the Aveir DR LP, compared to dual chamber transvenous pacemakers
Time frame: 2 years
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