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Leadless Pacemaker System

Leadless Pacemaker System for Arrhythmia

San Diego, CA
N/A
Waitlist Available
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must have at least one of the clinical indications before device implant in adherence with ACC/AHA/HRS/ESC dual chamber pacing guidelines
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is evaluating a new, leadless pacemaker system to see if it is safe and effective.

See full description
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks of pacemaker systems may include infection at the implant site, bleeding or bruising, lead displacement, allergic reactions to materials in the device including dexamethasone sodium phosphate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I meet the guidelines for needing a dual chamber pacemaker.
 show original

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Free From Aveir DR System-Related Complications at 12-months
Percentage of Participants Free From Aveir DR System-Related Complications at 3-months
Percentage of Participants With AV Synchrony Success Rate at Rest While Seated
+2 more
Secondary study objectives
Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 12-months
Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 3-months
Slope of the Normalized Increase in the Sensor Indicated Rate Versus Normalized Workload of the Aveir Atrial Leadless Pacemaker During Exercise Testing

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Non randomized arm

Find a Location

Closest Location:University of California at San Diego (UCSD) Medical Center· San Diego, CA

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
655 Previous Clinical Trials
417,541 Total Patients Enrolled
8 Trials studying Arrhythmia
3,684 Patients Enrolled for Arrhythmia
Nicole HarbertStudy DirectorAbbott
6 Previous Clinical Trials
7,368 Total Patients Enrolled
1 Trials studying Arrhythmia
586 Patients Enrolled for Arrhythmia
Clay CohornStudy DirectorAbbott
6 Previous Clinical Trials
13,969 Total Patients Enrolled
Grant KimStudy DirectorAbbott
10 Previous Clinical Trials
42,513 Total Patients Enrolled

Media Library

Aveir DR Leadless Pacemaker System (Leadless Pacemaker System) Clinical Trial Eligibility Overview. Trial Name: NCT05252702 — N/A
Arrhythmia Research Study Groups: Single Arm
Arrhythmia Clinical Trial 2023: Aveir DR Leadless Pacemaker System Highlights & Side Effects. Trial Name: NCT05252702 — N/A
Aveir DR Leadless Pacemaker System (Leadless Pacemaker System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05252702 — N/A
~116 spots leftby Feb 2026