Leadless Pacemaker System for Arrhythmia

Recruiting at 81 trial locations

Overseen By Binh Ngo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Disqualifiers: Pregnancy, Mechanical tricuspid valve, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

464 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the Aveir DR Leadless Pacemaker System treatment for arrhythmia?

The Aveir leadless pacemaker system has been approved by the FDA, indicating it meets safety and effectiveness standards for treating arrhythmias (irregular heartbeats). It offers a reliable alternative to traditional pacemakers, avoiding complications related to wires and pockets used in older systems. ^{1 2 3 4 5}

Is the Aveir leadless pacemaker system safe for humans?

The Aveir leadless pacemaker system has been approved by the FDA, indicating it meets safety standards for use in humans. It is designed to avoid some complications associated with traditional pacemakers, and early reports suggest it is safe, though more real-world safety data is still being gathered. ^{1 2 3 4 6}

How is the Aveir DR Leadless Pacemaker System treatment different from other treatments for arrhythmia?

The Aveir DR Leadless Pacemaker System is unique because it is a leadless pacemaker, meaning it does not require wires (leads) to connect to the heart, reducing complications associated with traditional pacemakers. It also offers the ability to be retrieved and repositioned if necessary, which is not possible with many other pacemaker systems. ^{1 2 3 5 7}

What is the purpose of this trial?

Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.

Research Team

Nicole Harbert

Principal Investigator

Abbott

Eligibility Criteria

This trial is for adults over 18 with a slow heart rate or other arrhythmias who need a pacemaker, can follow the study procedures, and have at least one year life expectancy. It's not for those with other active implants, existing pacing leads (except fragments), pregnant or nursing women, or anyone in another conflicting study.

Inclusion Criteria

I am at least 18 years old or the age of legal consent in my country.

I meet the guidelines for needing a dual chamber pacemaker.

Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC

Exclusion Criteria

You have a special filter or mechanical valve in your body.

You have a leadless cardiac pacemaker, except for a specific type called Aveir ventricular leadless pacemaker.

Subject has presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could confound the assessment of the investigational device and/or implant procedure, limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implant Procedure

Participants undergo the implant procedure for the Aveir DR Leadless Pacemaker system

1 day

1 visit (in-person)

Initial Follow-up

Participants are monitored for safety and effectiveness at 1 month, 3 months, and 6 months post-implant

6 months

3 visits (in-person)

Extended Follow-up

Participants continue to be monitored every 6 months until study completion

6 months to 12 months

2 visits (in-person)

Treatment Details

Interventions

• Aveir DR Leadless Pacemaker System

Trial Overview The Aveir DR Leadless Pacemaker System is being tested to see if it's safe and effective. This international study isn't random; all participants get the new device. They'll be monitored closely to see how well it works and what issues might come up.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

Non randomized arm

Who Is Running the Clinical Trial?

Abbott Medical Devices

Lead Sponsor

Trials

659

Recruited

420,000+

Founded

1888

Headquarters

Abbott Park, Illinois, USA

Known For

Medical Devices Innovation

Top Products

FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford

Abbott Medical Devices

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

References

1. United States pubmed.ncbi.nlm.nih.gov

The Aveir Leadless Pacing System receives FDA approval. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Leadless cardiac ventricular pacing using helix fixation: Step-by-step guide to implantation. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

First report of an Aveir retrievable leadless pacemaker in a pediatric patient, via internal jugular vein access. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A comparative study of the two leadless pacemakers in clinical practice. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Adverse events associated with AveirTM VR leadless pacemaker: A Food and Drug Administration MAUDE database study. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy and safety of leadless pacemaker: A systematic review, pooled analysis and meta-analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Leadless Cardiac Pacemakers: Back to the Future. [2015]