Leadless Pacemaker System for Arrhythmia

Recruiting in Palo Alto (17 mi)

+81 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Abbott Medical Devices

No Placebo Group

Trial Summary

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.

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

See 2 more

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

See 7 more

Treatment Details

Interventions

Aveir DR Leadless Pacemaker System (Leadless Pacemaker System)

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Non randomized arm