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Leadless Pacemaker System
Leadless Pacemaker System for Arrhythmia
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
Study Summary
This trial is evaluating a new, leadless pacemaker system to see if it is safe and effective.
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 belowSelect...
I meet the guidelines for needing a dual chamber pacemaker.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Subjects Free from Aveir DR System-Related Complications
Percentage of Subjects with Acceptable Atrial Threshold and Amplitude Measurements
Percentage of Subjects with a Ventricular Beat Followed by an Atrial Beat
Secondary outcome measures
Appropriate Rate Response of the Aveir Atrial Leadless Pacemaker During Exercise Testing
Number of Subjects Free from Aveir Atrial Leadless Pacemaker-Related Complications
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Non randomized arm
Find a Location
Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
638 Previous Clinical Trials
403,996 Total Patients Enrolled
18 Trials studying Arrhythmia
10,434 Patients Enrolled for Arrhythmia
Nicole HarbertStudy DirectorAbbott
4 Previous Clinical Trials
5,259 Total Patients Enrolled
1 Trials studying Arrhythmia
586 Patients Enrolled for Arrhythmia
Clay CohornStudy DirectorAbbott
6 Previous Clinical Trials
13,969 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.You are allergic to a small amount of dexamethasone sodium phosphate or any materials used in blood or tissue contact.You currently have an implanted defibrillator or cardiac therapy device.You have a medical device inside you that can send electrical signals, like a neurological or cardiac stimulator.You have permanent heart pacing or defibrillation leads in place.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current opportunities to participate in this clinical experiment?
"Conforming to information on the clinicaltrials.gov website, this exploration is currently enrolling participants. The initial post was published on February 3rd 2022 and its most recent update was November 15th 2022."
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