Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Ulrika Birgersdotter-Green
Headshot of Ulrika Birgersdotter-Green
Ulrika Birgersdotter-Green

Description

Summary

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

Official Title

Aveir Dual-Chamber Leadless i2i IDE Study

Details

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

Keywords

Cardiac Pacemaker, Artificial Cardiac Rhythm Disorder Bradycardia Sick Sinus Syndrome Pacemaker AV Block Vasovagal Syncope Arrhythmias, Cardiac Aveir DR Leadless Pacemaker System

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Subject must have at least one of the clinical indications before device implant in adherence with ACC/AHA/HRS/ESC dual chamber pacing guidelines
  2. Subject is ≥ 18 years of age or age of legal consent, whichever age is greater
  3. Subject has a life expectancy of at least one year
  4. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
  5. 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

You CAN'T join if...

  1. Subject is currently participating in another clinical investigation that may confound the results of this study as determined by the Sponsor
  2. Subject is pregnant or nursing and those who plan pregnancy during the clinical investigation follow-up period
  3. 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
  4. 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
  5. Subject has an implanted vena cava filter or mechanical tricuspid valve prosthesis
  6. Subject has pre-existing, permanent endocardial pacing or defibrillation leads (does not include lead fragments)
  7. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
  8. Subject has an implanted leadless cardiac pacemaker (except for an Aveir ventricular leadless pacemaker)
  9. Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators)
  10. . Subject is unable to read or write

Locations

  • University of California at San Diego (UCSD) Medical Center accepting new patients
    San Diego California 92118-8411 United States
  • Premier Cardiology, Inc accepting new patients
    Newport Beach California 92663 United States

Lead Scientist at UCSD

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Abbott Medical Devices
ID
NCT05252702
Study Type
Interventional
Participants
Expecting 550 study participants
Last Updated