Aveir DR i2i Study
Aveir Dual-Chamber Leadless i2i IDE Study
1 other identifier
interventional
464
13 countries
78
Brief Summary
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2022
Longer than P75 for not_applicable
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 2, 2022
CompletedFirst Submitted
Initial submission to the registry
February 9, 2022
CompletedFirst Posted
Study publicly available on registry
February 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2023
CompletedResults Posted
Study results publicly available
November 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedAugust 15, 2025
August 1, 2025
1.5 years
February 9, 2022
August 1, 2024
August 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Percentage of Participants Free From Aveir DR System-Related Complications at 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
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
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
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
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 Outcomes (3)
Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 3-months
3 months
Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 12-months
12 months
Slope of the Normalized Increase in the Sensor Indicated Rate Versus Normalized Workload of the Aveir Atrial Leadless Pacemaker During Exercise Testing
3 months
Study Arms (1)
Single Arm
OTHERNon randomized arm
Interventions
Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
HonorHealth
Scottsdale, Arizona, 85258, United States
Arrhythmia Research Group
Jonesboro, Arkansas, 72401, United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72211, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
USC University Hospital
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Premier Cardiology, Inc
Newport Beach, California, 92663, United States
Providence Medical Foundation
Orange, California, 92868, United States
Huntington Memorial Hospital
Pasadena, California, 91105, United States
University of California at San Diego (UCSD) Medical Center
San Diego, California, 92118-8411, United States
Pacific Heart Institute
Santa Monica, California, 90404, United States
South Denver Cardiology Associates PC
Littleton, Colorado, 80120, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Baptist Medical Center
Jacksonville, Florida, 32207, United States
Naples Heart Rhythm Specialists, PA
Naples, Florida, 34119, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
Emory University Hospital
Atlanta, Georgia, 30342, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Prairie Education & Research Cooperative
Springfield, Illinois, 62769, United States
Iowa Heart Center
West Des Moines, Iowa, 50266, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Charlton Memorial Hospital
Fall River, Massachusetts, 02720, United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
Providence Hospital
Southfield, Michigan, 48075, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Bryan Heart
Lincoln, Nebraska, 68506, United States
Catholic Medical Center
Manchester, New Hampshire, 03102, United States
Jersey Shore University Medical Center
Ocean City, New Jersey, 07712, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
New York University Hospital
New York, New York, 10016, United States
New York Presbyterian Hospital/Cornell University
New York, New York, 10021, United States
Mount Sinai Hospital
New York, New York, 10029, United States
New York-Presbyterian/Columbia University Medical Center
New York, New York, 10032, United States
Cardiac Arrhythmia & Pacemaker Center
Roslyn, New York, 11576, United States
Wake Forest University Medical Center Clinical Sciences
Winston-Salem, North Carolina, 27157, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio Health Research Institute
Columbus, Ohio, 43214, United States
Hightower Clinical
Oklahoma City, Oklahoma, 73102, United States
Oklahoma Heart Hospital South
Oklahoma City, Oklahoma, 73135, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17602, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Donald Guthrie Foundation for Education & Research
Sayre, Pennsylvania, 18840, United States
Sanford USD Medical Center
Sioux Falls, South Dakota, 57104, United States
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee, 37232, United States
Texas Cardiac Arrhythmia
Austin, Texas, 78705, United States
South Texas Cardiovascular Consultants
San Antonio, Texas, 78201, United States
Memorial Hermann Hospital
The Woodlands, Texas, 77380, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
Franciscan Heart & Vascular Associates
Tacoma, Washington, 98405, United States
Aurora Medical Group
Milwaukee, Wisconsin, 53215, United States
Aspirus Wausau Hospital
Wausau, Wisconsin, 54401, United States
Kepler Universitätsklinikum GmbH
Linz, Upper Austria, 4021, Austria
UZ Gasthuisberg
Leuven, Flemish Brabant, 3000, Belgium
Foothills Medical Centre
Calgary, Alberta, T2N 4N1, Canada
HSC, Eastern Health
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
QE II Health Sciences
Halifax, Nova Scotia, B3H 3A7, Canada
Southlake Regional Health Centre
Newmarket, Ontario, L3Y2P9, Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, Canada
Nemocnice Na Homolce
Prague, Czechia
Hopital d'adulte de la Timone
Marseille, Alpes, 13005, France
CHRU Albert Michallon
Grenoble, 38043, France
Prince of Wales Hospital
Hong Kong, HK SAR, Hong Kong
Queen Mary Hospital
Hong Kong, HK SAR, Hong Kong
Centro Cardiologico Monzino
Milan, 20138, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56100, Italy
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
Kurashiki Central Hospital
Kurashiki-shi, Okayama-ken, Japan
National Cerebral & Cardiovascular Center Hospital
Suita, Osaka, Japan
Tokyo Women's Medical University
Tokyo, Japan
Amsterdam Academic Medical Centre (AMC)
Amsterdam, 1105 AZ, Netherlands
Hospital Universitario de Badajoz
Badajoz, Extmdra, 06080, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
National Taiwan University Hospital
Taipei, Taiwan
John Radcliffe Hospital
Oxford, Soeast, OX3 9DU, United Kingdom
Royal Brompton Hospital
London, SW3 6NP, United Kingdom
Related Publications (7)
Defaye P, Reddy VY, Ip JE, Doshi RN, Exner DV, Canby RC, Bongiorni MG, Shoda M, Hindricks G, Rashtian MY, Neuzil P, Nevo JR, Badie N, Walker L, Knops RE. Atrioventricular Synchrony Maintained by a Dual-Chamber Leadless Pacemaker in Real-World Conditions. Europace. 2026 Jan 19:euag012. doi: 10.1093/europace/euag012. Online ahead of print.
PMID: 41554110DERIVEDKnops RE, Ip JE, Doshi R, Exner DV, Defaye P, Canby R, Bongiorni MG, Shoda M, Hindricks G, Neuzil P, Rashtian M, Breeman KTN, Nevo JR, Ganz L, Hubbard C, Bulusu A, Reddy VY. One-Year Safety and Performance of a Dual-Chamber Leadless Pacemaker. Circ Arrhythm Electrophysiol. 2025 Apr;18(4):e013619. doi: 10.1161/CIRCEP.124.013619. Epub 2025 Mar 27.
PMID: 40143804DERIVEDDoshi RN, Ip JE, Defaye P, Reddy VY, Exner DV, Canby R, Shoda M, Bongiorni MG, Hindricks G, Neuzil P, Callahan T, Sundaram S, Booth DF, Richer LP, Badie N, Knops RE. Dual-chamber leadless pacemaker implant procedural outcomes: Insights from the AVEIR DR i2i study. Heart Rhythm. 2025 Sep;22(9):2391-2400. doi: 10.1016/j.hrthm.2025.03.1941. Epub 2025 Mar 13.
PMID: 40089049DERIVEDRashtian MY, Ip JE, Exner DV, Reddy VY, Doshi RN, Defaye P, Canby RC, Bongiorni MG, Shoda M, Hindricks G, Nevo JR, Ligon D, Bulusu A, Knops RE. Temperature-based rate response in a leadless pacemaker system. Heart Rhythm. 2025 Jun;22(6):1533-1540. doi: 10.1016/j.hrthm.2024.11.032. Epub 2024 Nov 22.
PMID: 39581426DERIVEDDoshi RN, Ip JE, Defaye P, Exner DV, Reddy VY, Hindricks G, Canby R, Shoda M, Bongiorni MG, Neuzil P, Callahan T, Badie N, Ligon D, Knops RE. Chronic wireless communication between dual-chamber leadless pacemaker devices. Heart Rhythm. 2025 Apr;22(4):1010-1020. doi: 10.1016/j.hrthm.2024.10.020. Epub 2024 Oct 19.
PMID: 39427688DERIVEDKnops RE, Reddy VY, Ip JE, Doshi R, Exner DV, Defaye P, Canby R, Bongiorni MG, Shoda M, Hindricks G, Neuzil P, Rashtian M, Breeman KTN, Nevo JR, Ganz L, Hubbard C, Cantillon DJ; Aveir DR i2i Study Investigators. A Dual-Chamber Leadless Pacemaker. N Engl J Med. 2023 Jun 22;388(25):2360-2370. doi: 10.1056/NEJMoa2300080. Epub 2023 May 20.
PMID: 37212442DERIVEDReddy VY, Exner DV, Doshi R, Tomassoni G, Bunch TJ, Friedman P, Estes NAM, Neuzil P, de la Concha JF, Cantillon DJ; LEADLESS II Investigators. 1-Year Outcomes of a Leadless Ventricular Pacemaker: The LEADLESS II (Phase 2) Trial. JACC Clin Electrophysiol. 2023 Jul;9(7 Pt 2):1187-1189. doi: 10.1016/j.jacep.2023.01.031. Epub 2023 Mar 22. No abstract available.
PMID: 36951813DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nicole Harbert, Director of Clinical Research
- Organization
- Abbott Medical Devices, Cardiac Rhythm Management
Study Officials
- STUDY DIRECTOR
Nicole Harbert
Abbott
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2022
First Posted
February 23, 2022
Study Start
February 2, 2022
Primary Completion
August 2, 2023
Study Completion
November 1, 2025
Last Updated
August 15, 2025
Results First Posted
November 5, 2024
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- IPD will be available following publication of primary results for 25 years following study completion date.
- Access Criteria
- Proposals for requesting individual data may be submitted to the Sponsor at AveirDR\ IDE@abbott.com.
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.