Aveir DR i2i Study

  • STATUS
    Recruiting
  • End date
    Nov 14, 2025
  • participants needed
    550
  • sponsor
    Abbott Medical Devices
Updated on 7 October 2022
Investigator
Ashley Hunt
Primary Contact
HSC, Eastern Health (1.6 mi away) Contact
+77 other location

Summary

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

Description

The purpose of this clinical investigation is to evaluate the clinical safety and effectiveness of the Aveir DR Leadless Pacemaker system in a patient population indicated for a DDD(R) pacemaker.

Subjects participating in the study are followed through at least 12 months with data collected at baseline, implant procedure, pre (hospital) discharge, and follow-up at 1 month, 3 months, 6 months, 12 months, and every 6 months thereafter until study completion

Details
Condition Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder, Bradycardia
Treatment Aveir DR Leadless Pacemaker System
Clinical Study IdentifierNCT05252702
SponsorAbbott Medical Devices
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject must have at least one of the clinical indications before device implant in adherence with ACC/AHA/HRS/ESC dual chamber pacing guidelines
Subject is ≥ 18 years of age or age of legal consent, whichever age is greater
Subject has a life expectancy of at least one year
Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
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

Subject is currently participating in another clinical investigation that may confound the results of this study as determined by the Sponsor
Subject is pregnant or nursing and those who plan pregnancy during the clinical investigation follow-up period
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
Subject has a known allergy or hypersensitivity to < 1 mg of dexamethasone sodium phosphate or any blood or tissue contacting material listed in the IFU
Subject has an implanted vena cava filter or mechanical tricuspid valve prosthesis
Subject has pre-existing, permanent endocardial pacing or defibrillation leads (does not include lead fragments)
Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
Subject has an implanted leadless cardiac pacemaker (except for an Aveir ventricular leadless pacemaker)
Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators)
Subject is unable to read or write
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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