Plain-English translation of NCT05935007 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This is a safety monitoring study for the Aveir DR leadless pacemaker, a small device implanted in the heart to help it beat at a normal rhythm. Instead of running traditional clinic visits, researchers will collect information from your existing Medicare records and Abbott's medical records to track how well the device works and how safe it is over time.
The FDA approved this pacemaker with a requirement to continue monitoring its long-term safety in real patients. This study fulfills that requirement by gathering information from thousands of patients who have already received the device, rather than conducting separate clinic visits.
You likely qualify if…
You likely don't qualify if…
You don't need to do anything active — the research team will simply review your existing Medicare and Abbott medical records to track your pacemaker's performance and any complications. There are no extra clinic visits, tests, or procedures required. The study will follow your records for an extended period after your implant to ensure the device continues to work safely.
AI-generated summary from trial data · Aug 24, 2026 · Not medical advice
United States
Enrollment target
~1,805 participants
Started
October 2023
Primary completion
December 2030
Age range
18 Years and older
Last updated on clinicaltrials.gov in May 2026.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Nicole Harbert
Abbott
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.