Cardiac Pacemaker, ArtificialNCT05252702
Aveir DR i2i Study
A study testing Aveir DR Leadless Pacemaker System in people with Cardiac Pacemaker, Artificial and Cardiac Rhythm Disorder, run by Abbott Medical Devices at 78 sites in 13 countries.
Trial summary
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder, Bradycardia
- What is being tested?
- Aveir DR Leadless Pacemaker System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 464 participants
- Where
- 78 sitesin 13 countries
- Study dates
- 2 Feb 2022to 3 Feb 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
78 sites in 13 countries.
78 sites in 13 countries
United States54 sites
Piedmont Heart Institute
Atlanta, Georgia, 30309
Emory University Hospital
Atlanta, Georgia, 30342
Texas Cardiac Arrhythmia
Austin, Texas, 78705
Rush University Medical Center
Chicago, Illinois, 60612
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio Health Research Institute
Columbus, Ohio, 43214
Charlton Memorial Hospital
Fall River, Massachusetts, 02720
Baptist Medical Center
Jacksonville, Florida, 32207
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
Baptist Health Lexington
Lexington, Kentucky, 40503
Bryan Heart
Lincoln, Nebraska, 68506
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
South Denver Cardiology Associates PC
Littleton, Colorado, 80120
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
USC University Hospital
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Catholic Medical Center
Manchester, New Hampshire, 03102
North Shore University Hospital
Manhasset, New York, 11030
Aurora Medical Group
Milwaukee, Wisconsin, 53215
Naples Heart Rhythm Specialists, PA
Naples, Florida, 34119
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee, 37232
New York University Hospital
New York, New York, 10016
New York Presbyterian Hospital/Cornell University
New York, New York, 10021
Mount Sinai Hospital
New York, New York, 10029
New York-Presbyterian/Columbia University Medical Center
New York, New York, 10032
Premier Cardiology, Inc
Newport Beach, California, 92663
Jersey Shore University Medical Center
Ocean City, New Jersey, 07712
Hightower Clinical
Oklahoma City, Oklahoma, 73102
Oklahoma Heart Hospital South
Oklahoma City, Oklahoma, 73135
Providence Medical Foundation
Orange, California, 92868
AdventHealth Orlando
Orlando, Florida, 32803
Huntington Memorial Hospital
Pasadena, California, 91105
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Mayo Clinic
Rochester, Minnesota, 55905
Cardiac Arrhythmia & Pacemaker Center
Roslyn, New York, 11576
University of Utah Hospital
Salt Lake City, Utah, 84132
South Texas Cardiovascular Consultants
San Antonio, Texas, 78201
University of California at San Diego (UCSD) Medical Center
San Diego, California, 92118-8411
Pacific Heart Institute
Santa Monica, California, 90404
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Donald Guthrie Foundation for Education & Research
Sayre, Pennsylvania, 18840
HonorHealth
Scottsdale, Arizona, 85258
Sanford USD Medical Center
Sioux Falls, South Dakota, 57104
Providence Hospital
Southfield, Michigan, 48075
Prairie Education & Research Cooperative
Springfield, Illinois, 62769
Franciscan Heart & Vascular Associates
Tacoma, Washington, 98405
Memorial Hermann Hospital
The Woodlands, Texas, 77380
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Aspirus Wausau Hospital
Wausau, Wisconsin, 54401
Iowa Heart Center
West Des Moines, Iowa, 50266
Wake Forest University Medical Center Clinical Sciences
Winston-Salem, North Carolina, 27157
Canada5 sites
Foothills Medical Centre
Calgary, Alberta, T2N 4N1
QE II Health Sciences
Halifax, Nova Scotia, B3H 3A7
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec
Southlake Regional Health Centre
Newmarket, Ontario, L3Y2P9
HSC, Eastern Health
St. John's, Newfoundland and Labrador, A1B 3V6
Japan4 sites
Kokura Memorial Hospital
Kitakyushu, Fukuoka
Kurashiki Central Hospital
Kurashiki-shi, Okayama-ken
National Cerebral & Cardiovascular Center Hospital
Suita, Osaka
Tokyo Women's Medical University
Tokyo
France2 sites
CHRU Albert Michallon
Grenoble, 38043
Hopital d'adulte de la Timone
Marseille, Alpes, 13005
Hong Kong2 sites
Prince of Wales Hospital
Hong Kong, HK SAR
Queen Mary Hospital
Hong Kong, HK SAR
Italy2 sites
Centro Cardiologico Monzino
Milan, 20138
Azienda Ospedaliero Universitaria Pisana
Pisa, 56100
Spain2 sites
Hospital Universitario de Badajoz
Badajoz, Extmdra, 06080
Hospital Clínic de Barcelona
Barcelona, 08036
United Kingdom2 sites
Royal Brompton Hospital
London, SW3 6NP
John Radcliffe Hospital
Oxford, Soeast, OX3 9DU
Netherlands1 site
Amsterdam Academic Medical Centre (AMC)
Amsterdam, 1105 AZ
About this study
Official title: 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.
Read the 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
- Being tested
- Aveir DR Leadless Pacemaker System
- Keywords
- Bradycardia, Sick Sinus Syndrome, Pacemaker, AV Block, Vasovagal Syncope
- Medical subject headings
- Arrhythmias, Cardiac, Bradycardia, Sick Sinus Syndrome, Atrioventricular Block, Syncope, Vasovagal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aveir DR Leadless Pacemaker SystemDevice
Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Non randomized arm Receives: Device: Aveir DR Leadless Pacemaker System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (3)
Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 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.
Measured: 3 months
Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 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.
Measured: 12 months
Slope of the Normalized Increase in the Sensor Indicated Rate Versus Normalized Workload of the Aveir Atrial Leadless Pacemaker During Exercise Testing
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start2 Feb 2022
- Primary completion2 Aug 2023
- Study completion3 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiac Pacemaker, ArtificialStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multi-center, international, single-arm, pivotal investigational study
- Masking
- None (open label)
- Enrolment
- 464 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicole Harbert, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252702
- Sponsor's protocol ID
- ABT-CIP-10416
- Status last verified
- May 2026
- First submitted
- 9 Feb 2022
- Last updated
- 27 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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 Feb 3;28(2):euag012. doi: 10.1093/europace/euag012.
PubMed 41554110Knops 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.
PubMed 40143804Doshi 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.
PubMed 40089049Rashtian 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.
PubMed 39581426Doshi 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.
PubMed 39427688Hindricks G, Doshi R, Defaye P, Exner DV, Reddy VY, Knops RE, Canby R, Shoda M, Bongiorni MG, Neuzil P, Callahan T, Sundaram S, Badie N, Ip JE. Six-month electrical performance of the first dual-chamber leadless pacemaker. Heart Rhythm. 2024 Oct;21(10):1929-1938. doi: 10.1016/j.hrthm.2024.04.091. Epub 2024 Apr 30.
PubMed 38697271Knops 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.
PubMed 37212442Reddy 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.
PubMed 36951813
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aveir Dual-Chamber Leadless i2i IDE Study
- ClinicalTrials.gov ID
- NCT05252702
- Acronym / sponsor ID
- ABT-CIP-10416
- Keywords
- Bradycardia, Sick Sinus Syndrome, Pacemaker, AV Block, Vasovagal Syncope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 464 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 2 Aug 2023 (actual)
- Study completion
- 3 Feb 2026 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Posted 5 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multi-center, international, single-arm, pivotal investigational study
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: Aveir DR Leadless Pacemaker SystemNon randomized arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aveir DR Leadless Pacemaker SystemPatients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium | Device | Single Arm |
Primary outcome
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.
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.
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.
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.
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 secondary outcomes
Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 3-months
Time frame: 3 months
Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 12-months
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41554110Defaye 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 Feb 3;28(2):euag012. doi: 10.1093/europace/euag012.
- Derived from this study: PubMed 40143804Knops 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.
- Derived from this study: PubMed 40089049Doshi 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.
- Derived from this study: PubMed 39581426Rashtian 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.
- Derived from this study: PubMed 39427688Doshi 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.
- Derived from this study: PubMed 38697271Hindricks G, Doshi R, Defaye P, Exner DV, Reddy VY, Knops RE, Canby R, Shoda M, Bongiorni MG, Neuzil P, Callahan T, Sundaram S, Badie N, Ip JE. Six-month electrical performance of the first dual-chamber leadless pacemaker. Heart Rhythm. 2024 Oct;21(10):1929-1938. doi: 10.1016/j.hrthm.2024.04.091. Epub 2024 Apr 30.
- Derived from this study: PubMed 37212442Knops 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.
- Derived from this study: PubMed 36951813Reddy 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.
- Individual participant dataSharing planned: Yes. 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.
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Predicting Severe Cardiac Arrhythmias in the Perioperative Period Using AI-ECG
Atrial Fibrillation, Atrioventricular Block, Second and Third Degree
Enrolling by invitationObservational study
OPTimising a Screening Program to Detect Pacemaker-associated Heart Failure Using Artificial Intelligence
Heart Failure, Pacemaker
RecruitingObservational study
Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
Pacemaker, Leadless Pacemaker
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Harbert study director
Abbott
78 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aveir DR Leadless Pacemaker System in people with Cardiac Pacemaker, Artificial and Cardiac Rhythm Disorder, run by Abbott Medical Devices at 78 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in United States, Canada, Japan, France, Hong Kong and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Free From Aveir DR System-Related Complications at 3-months (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05252702, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.