Aveir DR Real-World Evidence Post-Approval Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aveir DR Leadless Pacemaker System.
- Who it may be relevant to
- Registry conditions: Cardiac Pacemaker, Arrythmia, Bradycardia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Aveir Dual-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study
Overview
The purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.
Detailed description
This is a non-randomized, multi-center study leveraging real-world evidence methods that merge multiple real-world datasets from Abbott and the Center for Medicare Services to assess Aveir DR leadless pacemaker safety in a large patient population. The results from this study will provide long-term safety data for the Aveir dual chamber LP and the Aveir atrial LP to fulfill the Condition of Approval requirements for the Aveir DR device from FDA.
Due to the RWE data collection methods used in this study, a central 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.
Interventions
- Device Aveir DR Leadless Pacemaker System
This study will utilize real-world data from patients implanted with the Aveir DR Leadless Pacemaker System. No device intervention will be conducted in this study.
Primary outcome measures
- Number of Subjects Free from Acute Aveir DR System-Related Complications [Time frame: 30 Days]
- Number of Subjects Free from Chronic Aveir DR System-Related Complications [Time frame: 5 Years]
Secondary outcome measures (2)
- Number of Subjects Free from Individual Aveir DR Leadless Pacemaker-Related [Time frame: 5 Years]
- Number of Subjects with End of Device Service Events [Time frame: 5 Years]
Eligibility criteria
Eligibility Criteria:
- Implanted with an Aveir DR leadless pacemaker
- Continuous enrollment in Medicare Part A and Part B for 12 months prior to implant and for -30 days after implant, except in the case of death within the 30-day period
- Ability to link with Medicare fee-for-service data
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Abbott — Sylmar
Identifiers
NCT: NCT05935007 · ABT-CIP-10454