Evaluating the long-term safety of the Aveir DR leadless pacemaker

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods. It is a non-randomized, multi-center study that combines various real-world datasets from Abbott and the Center for Medicare Services to evaluate the safety of the Aveir DR device in a large patient population. The findings will fulfill the FDA's Condition of Approval requirements for the Aveir DR device by providing essential long-term safety data.

Why it matters

Who can join: the full rules

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

Where it's running

• Abbott
  Sylmar, California, United States Recruiting

Study contacts

• Study coordinator: Nicole Harbert
• Email: nicole.harbert@abbott.com
• Phone: 972-526-4841

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BIOTRONIK CSP Lead Registry for Left Bundle Branch Area Pacing

  This registry tests BIOTRONIK’s CSP-based pacing lead in patients needing a pacemaker or CRT, to see how it performs in real-life use.

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• Leadless Conduction System Pacemaker for Chronic Bradycardia

  This study tests a leadless AVEIR CSP pacemaker to see if it safely and reliably keeps heart rhythm in adults who need a pacemaker.

  Recruiting Abbott Medical Devices · Prague · NCT07287423

• Evaluating the Aveir Atrial Leadless Pacemaker for Medicare Patients

  This study is testing how well the Aveir Atrial Leadless Pacemaker works and what complications it might cause for Medicare patients compared to a regular pacemaker.

  Recruiting Abbott Medical Devices · Sylmar, California · NCT06100770

• SPIKE FLOW endocardial pacing lead safety and performance study

  This study tests whether the SPIKE FLOW temporary endocardial pacing lead is safe and effective in adults needing temporary pacing during heart-related conditions.

  Recruiting at 2 sites FIAB SpA · Acquaviva delle Fonti, Bari and 2 other locations · NCT07820072

• Factors Linked to Slow Heart Rate After Pulsed Field Ablation for Atrial Fibrillation

  This study looks for factors that might cause bradycardia during the hospital stay after AF ablation using pulsed field technology.

  Recruiting Wroclaw Medical University · Wroclaw, Lower Silesian Voivodeship · NCT07809347

• Transjugular implantation of a leadless pacemaker (Aveir VR) for ventricular pacing

  This study tests whether placing an Aveir VR leadless pacemaker through the neck vein can safely provide ventricular pacing in adults with bradycardia.

  Recruiting Xijing Hospital · Xi'an, Shaanxi · NCT07802119

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.