AVEIR DR Coverage With Evidence Development (CED) Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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The AVEIR DR Coverage With Evidence Development (DRIVE) Study

Conditions
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Cardiac Pacemaker, Arrythmia, Bradycardia

Intervention / Treatment
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* Device: Aveir DR Leadless Pacemaker System
* Device: Dual Chamber Transvenous Pacemaker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medicare beneficiaries implanted with an Aveir DR leadless pacemaker on or after the study start date (i.e., the date of Aveir DR market approval) will be included in the study. OR Medicare beneficiaries implanted with a full system (e.g. lead and generator) dual-chamber transvenous pacemaker on or after the study start date Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aveir DR Leadless Pacemaker System<br>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. | Device: Aveir DR Leadless Pacemaker System<br>* 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.<br>|
| Dual Chamber Transvenous Pacemaker<br>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. | Device: Dual Chamber Transvenous Pacemaker<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute 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. | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dual chamber, sick sinus rhythm, pacemaker, AV Block