Leadless Pacemaker System for Arrhythmia

Not currently recruiting at 85 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of pacemaker called the Aveir™ Dual-Chamber (DR) Leadless Pacemaker. The goal is to determine if this device is safe and effective for individuals needing help with heartbeat regulation due to arrhythmia (irregular heartbeat). As a single-arm study, all participants will receive the same treatment. This trial may suit those who require a dual-chamber pacemaker and do not already have certain types of pacemakers or defibrillators implanted. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment option.

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 prior data suggests that the Aveir DR Leadless Pacemaker System is safe?

Research has shown that the Aveir™ Dual-Chamber (DR) Leadless Pacemaker System is generally safe for people. Studies have found that this pacemaker can address heart rhythm problems without the typical issues of traditional pacemakers, such as wire complications and chest infections.

In one study, 99% of patients successfully received pacemaker implants. Another study found that safety goals were met after one year, consistent with results seen after three months. This consistent safety over time is reassuring.

Overall, the Aveir DR Leadless Pacemaker System appears well-tolerated, with evidence suggesting it is a safe choice for those needing a pacemaker. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional pacemakers, which require leads to connect the device to the heart, the Aveir DR Leadless Pacemaker System is entirely self-contained and implanted directly into the heart. This innovative design eliminates the need for leads, which can sometimes cause complications such as infections or lead dislodgement. Researchers are excited about this treatment because it simplifies the implantation procedure, potentially reduces recovery time, and lowers the risk of long-term complications associated with lead-based systems.

What evidence suggests that the Aveir DR Leadless Pacemaker System is effective for arrhythmia?

Research shows that the Aveir DR Leadless Pacemaker System effectively treats irregular heartbeats. Studies have found that this pacemaker maintains a steady heart rhythm without traditional wires, reducing wire-related complications. One study found that the pacemaker provided reliable heart pacing and synchronized the heart's rhythm. Another study confirmed its safety and effectiveness for patients requiring heart pacing. Overall, the evidence supports its effectiveness in managing heart rhythm issues. ^{1 3 6 7 8}

Who Is on the Research Team?

Nicole Harbert

Principal Investigator

Abbott

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.124.013619?doi=10.1161/CIRCEP.124.013619

One-Year Safety and Performance of a Dual-Chamber ... A dual-chamber leadless pacemaker can provide bradycardia therapy to most patients with pacemaker indications without the complications associated with a lead ...

2. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)02176-9/fulltext

Dual-chamber leadless pacemaker implant procedural ... The purpose of this study was to evaluate procedural outcomes and learning curve for de novo implantation of the dual-chamber LP (AVEIR DR, Abbott, Abbott Park ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05252702

Study Details | NCT05252702 | Aveir DR i2i Study The purpose of this clinical investigation is to evaluate the clinical safety and effectiveness of the Aveir DR Leadless Pacemaker system in a patient ...

4. cardiovascular.abbott cardiovascular.abbott/us/en/hcp/products/cardiac-rhythm-management/pacemakers/aveir-dr-dual-chamber-leadless-pacemaker-system/clinical-evidence.html

AVEIR Clinical Evidence The key findings of clinical studies outlined here have contributed to our understanding of the safety and efficacy profile of leadless pacemakers.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2300080

A Dual-Chamber Leadless Pacemaker The dual-chamber leadless pacemaker system met the primary safety end point and provided atrial pacing and reliable atrioventricular synchrony ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40143804

One-Year Safety and Performance of a Dual-Chamber ... Conclusions: Both primary safety and performance end points were met after 1 year, demonstrating consistency with previously reported 3-month outcomes of a dual ...

7. cardiovascular.abbott cardiovascular.abbott/us/en/hcp/products/cardiac-rhythm-management/blog/evidence-shows-leadless-improving-patient-quality-of-life.html

Real-World Evidence Demonstrates Leadless Pacing ... This real-world evidence (RWE) from a US nationwide study shows that leadless pacemakers prevent lead complications and chest pocket infections.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf15/P150035S003B.pdf

summary of safety and effectiveness data (ssed) The test results demonstrate that the Aveir. Leadless Pacemaker is conditionally safe for use in the MRI environments when used according to the ...