Aveir DR i2i Study

May 11, 2026 updated by: Abbott Medical Devices

Aveir Dual-Chamber Leadless i2i IDE Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

464

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Upper Austria
      • Linz, Upper Austria, Austria, 4021
        • Kepler Universitatsklinikum GmbH
  • Belgium
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium, 3000
        • Uz Gasthuisberg
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Foothills Medical Centre
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • HSC, Eastern Health
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QE II Health Sciences
    • Ontario
      • Newmarket, Ontario, Canada, L3Y2P9
        • Southlake Regional Health Centre
    • Quebec
      • Montreal, Quebec, Canada
        • Institut de Cardiologie de Montreal (Montreal Heart Inst.)
  • Czechia
      • Prague, Czechia
        • Nemocnice na Homolce
  • France
      • Grenoble, France, 38043
        • CHRU Albert Michallon
    • Alpes
      • Marseille, Alpes, France, 13005
        • Hopital d'adulte de la Timone
  • Hong Kong
      • Hong Kong, Hong Kong, HK SAR
        • Queen Mary Hospital
    • HK SAR
      • Hong Kong, HK SAR, Hong Kong
        • Prince of Wales Hospital
  • Italy
      • Milan, Italy, 20138
        • Centro Cardiologico Monzino
      • Pisa, Italy, 56100
        • Azienda Ospedaliero Universitaria Pisana
  • Japan
      • Tokyo, Japan
        • Tokyo Women's Medical University
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan
        • Kokura Memorial Hospital
    • Okayama-ken
      • Kurashiki-shi, Okayama-ken, Japan
        • Kurashiki Central Hospital
    • Osaka
      • Suita, Osaka, Japan
        • National Cerebral & Cardiovascular Center Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Amsterdam Academic Medical Centre (AMC)
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
    • Extmdra
      • Badajoz, Extmdra, Spain, 06080
        • Hospital Universitario de Badajoz
  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital
  • United Kingdom
      • London, United Kingdom, SW3 6NP
        • Royal Brompton Hospital
    • Soeast
      • Oxford, Soeast, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Arrhythmia Research Group
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Heart Hospital
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Los Angeles, California, United States, 90033
        • USC University Hospital
      • Newport Beach, California, United States, 92663
        • Premier Cardiology, Inc
      • Orange, California, United States, 92868
        • Providence Medical Foundation
      • Pasadena, California, United States, 91105
        • Huntington Memorial Hospital
      • San Diego, California, United States, 92118-8411
        • University of California at San Diego (UCSD) Medical Center
      • Santa Monica, California, United States, 90404
        • Pacific Heart Institute
    • Colorado
      • Littleton, Colorado, United States, 80120
        • South Denver Cardiology Associates PC
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Medical Center
      • Naples, Florida, United States, 34119
        • Naples Heart Rhythm Specialists, PA
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Heart Institute
      • Atlanta, Georgia, United States, 30342
        • Emory University Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Springfield, Illinois, United States, 62769
        • Prairie Education & Research Cooperative
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Heart Center
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • Charlton Memorial Hospital
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Sparrow Clinical Research Institute
      • Southfield, Michigan, United States, 48075
        • Providence Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Bryan Heart
    • New Hampshire
      • Manchester, New Hampshire, United States, 03102
        • Catholic Medical Center
    • New Jersey
      • Ocean City, New Jersey, United States, 07712
        • Jersey Shore University Medical Center
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10016
        • New York University Hospital
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
      • New York, New York, United States, 10032
        • New York-Presbyterian/Columbia University Medical Center
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital/Cornell University
      • Roslyn, New York, United States, 11576
        • Cardiac Arrhythmia & Pacemaker Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Medical Center Clinical Sciences
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43214
        • Ohio Health Research Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Hightower Clinical
      • Oklahoma City, Oklahoma, United States, 73135
        • Oklahoma Heart Hospital South
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence St. Vincent Medical Center
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17602
        • Lancaster General Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
      • Sayre, Pennsylvania, United States, 18840
        • Donald Guthrie Foundation for Education & Research
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford USD Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Heart & Vascular Institute
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia
      • San Antonio, Texas, United States, 78201
        • South Texas Cardiovascular Consultants
      • The Woodlands, Texas, United States, 77380
        • Memorial Hermann Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital
    • Washington
      • Tacoma, Washington, United States, 98405
        • Franciscan Heart & Vascular Associates
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Medical Group
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Wausau Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  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

Exclusion Criteria:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm
Non randomized arm
Device: Aveir DR Leadless Pacemaker System
Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Free From Aveir DR System-Related Complications at 3-months
Time Frame: 3 months
Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects. A complication was defined as a device-or-procedure-related serious adverse event. Complications included Atrial LP, Ventricular LP, and implant procedure-related complications. Complications possibly related or related to COVID-19 were excluded.
3 months
Percentage of Participants Free From Aveir DR System-Related Complications at 12-months
Time Frame: 12 months
Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects. A complication was defined as a device-or-procedure-related serious adverse event. Complications included Atrial LP, Ventricular LP, and implant procedure-related complications. Complications possibly related or related to COVID-19 were excluded.
12 months
Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 3-months
Time Frame: 3 months
Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. A subject was considered to have met the primary effectiveness endpoint #1 if the pacing threshold voltage was ≤ 3.0 V at 0.4 ms at the 3-month visit and the sensed P-wave amplitude was ≥ 1.0 mV at the 3-month visit.
3 months
Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 12-months
Time Frame: 12 months
Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. A subject was considered to have met the success criteria for the endpoint if the pacing threshold voltage was ≤ 3.0 V at 0.4 ms at the 12-month visit and the sensed P-wave amplitude was ≥ 1.0 mV at the 12-month visit.
12 months
Percentage of Participants With AV Synchrony Success Rate at Rest While Seated
Time Frame: 3 months
AV synchrony success was defined as subjects with a paced or sensed ventricular beat within 300 ms following a paced or sensed atrial beat (i.e., a synchronous cycle) for at least 70% of evaluable cardiac cycles.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 3-months
Time Frame: 3 months
The secondary safety endpoint evaluated a 3-month Atrial LP related complication-free rate based on CEC adjudication of adverse events. An Atrial LP complication was defined as an atrial device-or-procedure-related serious adverse event. Complications that were exclusively related to the Ventricular LP or its delivery/retrieval were not considered Atrial LP complications and were excluded from the evaluation. For a conservative approach, complications that could not exclusively be determined to be related to the ventricular or Atrial LP were still considered Atrial LP complications. For example, procedure-related femoral access complications were adjudicated as Atrial LP complications.
3 months
Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 12-months
Time Frame: 12 months
The secondary safety endpoint analysis evaluated the 12-month Atrial LP related complication-free rate (CFRA) based on CEC adjudication of adverse events. An Atrial LP complication was defined as an atrial device-or-procedure-related serious adverse event. Complications that were exclusively related to the Ventricular LP or its delivery/retrieval were not considered Atrial LP complications and were excluded from the evaluation. For a conservative approach, complications that could not exclusively be determined to be related to the ventricular or Atrial LP were still considered Atrial LP complications. For example, procedure-related femoral access complications were adjudicated as Atrial LP complications. Complications possibly related or related to COVID-19 were excluded.
12 months
Slope of the Normalized Increase in the Sensor Indicated Rate Versus Normalized Workload of the Aveir Atrial Leadless Pacemaker During Exercise Testing
Time Frame: 3 months
Appropriate and proportional rate response of the Aveir Atrial Leadless Pacemaker in de novo subjects was tested during staged exercise testing. Exercise test data provided an estimate of the slope of the normalized increase in sensor-indicated rate versus normalized workload for each subject. Normalizing a variable eliminates the unit and expresses it from 0-1.0. Since both axes are normalized sensor rate and workload, there is no distinct unit of measure. Values on the vertical axis are derived from the difference of the sensor indicated rate at each exercise stage and the base rate, divided by the difference of the age-predicted maximum heart rate and base rate. Values on the horizontal axis are derived from the difference in the workload at each exercise stage and resting workload, divided by the difference of the maximum achieved workload and resting workload. A slope value of 1.0 indicates the pacemaker's sensor-indicated rate increases linearly with an increase in workload.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Study Director: Nicole Harbert, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2022

Primary Completion (Actual)

August 2, 2023

Study Completion (Actual)

February 3, 2026

Study Registration Dates

First Submitted

February 9, 2022

First Submitted That Met QC Criteria

February 17, 2022

First Posted (Actual)

February 23, 2022

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT-CIP-10416

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Any de-identified individual participant data collected will be shared with investigators or other study committee members whose proposed use of the data has been approved by the Aveir DR i2i Study Steering Committee.

IPD Sharing Time Frame

IPD will be available following publication of primary results for 25 years following study completion date.

IPD Sharing Access Criteria

Proposals for requesting individual data may be submitted to the Sponsor at AveirDR_IDE@abbott.com.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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