Aveir DR i2i Study

Last updated: August 13, 2025
Sponsor: Abbott Medical Devices
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Dysrhythmia

Low Blood Pressure (Hypotension)

Heart Disease

Treatment

Aveir DR Leadless Pacemaker System

Clinical Study ID

NCT05252702
ABT-CIP-10416
  • Ages > 18
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  1. Subject must have at least one of the clinical indications before device implant inadherence 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 toreturn 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 itsprovisions and has provided a signed written informed consent, approved by theIRB/EC

Exclusion

Exclusion Criteria:

  1. Subject is currently participating in another clinical investigation that mayconfound the results of this study as determined by the Sponsor

  2. Subject is pregnant or nursing and those who plan pregnancy during the clinicalinvestigation 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 theassessment of the investigational device and/or implant procedure, limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements of the clinical investigation results

  4. Subject has a known allergy or hypersensitivity to < 1 mg of dexamethasone sodiumphosphate 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 (doesnot include lead fragments)

  7. Subject has current implantation of either conventional or subcutaneous implantablecardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device

  8. Subject has an implanted leadless cardiac pacemaker (except for an Aveir ventricularleadless pacemaker)

  9. Subject is implanted with an electrically-active implantable medical device withstimulation capabilities (such as neurological or cardiac stimulators)

  10. Subject is unable to read or write

Study Design

Total Participants: 464
Treatment Group(s): 1
Primary Treatment: Aveir DR Leadless Pacemaker System
Phase:
Study Start date:
February 02, 2022
Estimated Completion Date:
November 30, 2025

Study 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

Connect with a study center

  • Kepler Universitätsklinikum GmbH

    Linz, Upper Austria 4021
    Austria

    Site Not Available

  • UZ Gasthuisberg

    Leuven, Flemish Brabant 3000
    Belgium

    Site Not Available

  • Foothills Medical Centre

    Calgary, Alberta T2N 4N1
    Canada

    Site Not Available

  • HSC, Eastern Health

    Saint John's, Newfoundland and Labrador A1B 3V6
    Canada

    Site Not Available

  • QE II Health Sciences

    Halifax, Nova Scotia B3H 3A7
    Canada

    Site Not Available

  • Southlake Regional Health Centre

    Newmarket, Ontario L3Y2P9
    Canada

    Site Not Available

  • Institut de Cardiologie de Montreal (Montreal Heart Inst.)

    Montréal, Quebec
    Canada

    Site Not Available

  • Nemocnice Na Homolce

    Prague,
    Czechia

    Site Not Available

  • Hopital d'adulte de la Timone

    Marseille, Alpes 13005
    France

    Site Not Available

  • CHRU Albert Michallon

    Grenoble, 38043
    France

    Site Not Available

  • Kerckhoff-Klinik gGmbH

    Bad Nauheim, 61231
    Germany

    Site Not Available

  • Herzzentrum Leipzig GmbH

    Leipzig, 04289
    Germany

    Site Not Available

  • Prince of Wales Hospital

    Hong Kong, Hk Sar
    Hong Kong

    Site Not Available

  • Queen Mary Hospital

    Hong Kong, HK SAR
    Hong Kong

    Site Not Available

  • Centro Cardiologico Monzino

    Milano, 20138
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56100
    Italy

    Site Not Available

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka
    Japan

    Site Not Available

  • Kurashiki Central Hospital

    Kurashiki-shi, Okayama
    Japan

    Site Not Available

  • National Cerebral & Cardiovascular Center Hospital

    Suita, Osaka
    Japan

    Site Not Available

  • Tokyo Women's Medical University

    Tokyo,
    Japan

    Site Not Available

  • Amsterdam Academic Medical Centre (AMC)

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Hospital Universitario de Badajoz

    Badajoz, Extmdra 06080
    Spain

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • National Taiwan University Hospital

    Taipei,
    Taiwan

    Site Not Available

  • John Radcliffe Hospital

    Oxford, Soeast OX3 9DU
    United Kingdom

    Site Not Available

  • Royal Brompton Hospital

    London, SW3 6NP
    United Kingdom

    Site Not Available

  • Cardiology Associates of Mobile, Inc.

    Mobile, Alabama 36608
    United States

    Site Not Available

  • HonorHealth

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Arrhythmia Research Group

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Arkansas Heart Hospital

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California 90027
    United States

    Site Not Available

  • USC University Hospital

    Los Angeles, California 90033
    United States

    Site Not Available

  • Premier Cardiology, Inc

    Newport Beach, California 92663
    United States

    Site Not Available

  • Providence Medical Foundation

    Orange, California 92868
    United States

    Site Not Available

  • Huntington Memorial Hospital

    Pasadena, California 91105
    United States

    Site Not Available

  • University of California at San Diego (UCSD) Medical Center

    San Diego, California 92118-8411
    United States

    Site Not Available

  • Pacific Heart Institute

    Santa Monica, California 90404
    United States

    Site Not Available

  • South Denver Cardiology Associates PC

    Littleton, Colorado 80120
    United States

    Site Not Available

  • Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Baptist Medical Center

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Naples Heart Rhythm Specialists, PA

    Naples, Florida 34119
    United States

    Site Not Available

  • AdventHealth Orlando

    Orlando, Florida 32803
    United States

    Site Not Available

  • Sarasota Memorial Hospital

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Piedmont Heart Institute

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Prairie Education & Research Cooperative

    Springfield, Illinois 62769
    United States

    Site Not Available

  • Iowa Heart Center

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Kansas City Cardiac Arrhythmia Research Foundation

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • Baptist Health Lexington

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Ochsner Medical Center

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Charlton Memorial Hospital

    Fall River, Massachusetts 02720
    United States

    Site Not Available

  • Sparrow Clinical Research Institute

    Lansing, Michigan 48912
    United States

    Site Not Available

  • Providence Hospital

    Southfield, Michigan 48075
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Bryan Heart

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • Catholic Medical Center

    Manchester, New Hampshire 03102
    United States

    Site Not Available

  • Jersey Shore University Medical Center

    Ocean City, New Jersey 07712
    United States

    Site Not Available

  • North Shore University Hospital

    Manhasset, New York 11030
    United States

    Site Not Available

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • New York Presbyterian Hospital/Cornell University

    New York, New York 10021
    United States

    Site Not Available

  • New York University Hospital

    New York, New York 10016
    United States

    Site Not Available

  • New York-Presbyterian/Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Cardiac Arrhythmia & Pacemaker Center

    Roslyn, New York 11576
    United States

    Site Not Available

  • Wake Forest University Medical Center Clinical Sciences

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Ohio Health Research Institute

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Hightower Clinical

    Oklahoma City, Oklahoma 73102
    United States

    Site Not Available

  • Oklahoma Heart Hospital South

    Oklahoma City, Oklahoma 73135
    United States

    Site Not Available

  • Providence St. Vincent Medical Center

    Portland, Oregon 97225
    United States

    Site Not Available

  • Lancaster General Hospital

    Lancaster, Pennsylvania 17602
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Donald Guthrie Foundation for Education & Research

    Sayre, Pennsylvania 18840
    United States

    Site Not Available

  • Pinnacle Health System

    Wormleysburg, Pennsylvania 17043
    United States

    Site Not Available

  • Sanford USD Medical Center

    Sioux Falls, South Dakota 57104
    United States

    Site Not Available

  • Vanderbilt Heart & Vascular Institute

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Texas Cardiac Arrhythmia

    Austin, Texas 78705
    United States

    Site Not Available

  • The Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • South Texas Cardiovascular Consultants

    San Antonio, Texas 78201
    United States

    Site Not Available

  • Memorial Hermann Hospital

    The Woodlands, Texas 77380
    United States

    Site Not Available

  • University of Utah Hospital

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Franciscan Heart & Vascular Associates

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Aurora Medical Group

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

  • Aspirus Wausau Hospital

    Wausau, Wisconsin 54401
    United States

    Site Not Available

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