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Clinical Trials in the USA / NCT05935007
Recruiting Observational

Aveir DR Real-World Evidence Post-Approval Study

NCT05935007 · tracked via the Priya Life Science USA tracker
Sponsor
Abbott Medical Devices
Phase
Observational
Started
2023-10-31
Last updated
2026-05-20

Condition(s) studied

Cardiac PacemakerArrythmiaBradycardia

Investigational drug(s) / intervention(s)

Aveir DR Leadless Pacemaker System

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of Subjects Free from Acute Aveir DR System-Related Complications — 30 Days
    Freedom from key acute complications through 30 days post implant procedure
  • Number of Subjects Free from Chronic Aveir DR System-Related Complications — 5 Years
    Freedom from key chronic complications from 31 days through 5 years post implant procedure procedure

Trial sites (1)

FacilityCityRegionStatus
Abbott Sylmar California Recruiting

More Abbott Medical Devices trials in the USA

Cephea Early Feasibility Study Recruiting
SyncAV Post-Market Trial Active, not recruiting
AVEIR DR Coverage With Evidence Development (CED) Study Active, not recruiting
AMPLATZER PFO Occluder Post Approval Study Active, not recruiting
Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation Active, not recruiting

Other trials for the same condition

AVEIR DR Coverage With Evidence Development (CED) Study Active, not recruiting
Cardiac Implantable Electronic Device (CIED) Research Study Active, not recruiting
Micra Transcatheter Pacing System Post-Approval Registry Active, not recruiting
HeartBeam ECG Registry Recruiting
Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers (Micra AV CED) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05935007 on ClinicalTrials.gov ↗ ← All trials in the USA