Leadless PacemakerNCT07106788
Aveir Leadless Pacemaker Japan PMS
An observational study of Leadless Pacemaker, run by Abbott Medical Devices at 14 sites in Japan.
Trial summary
The primary purpose of the PMS is to collect safety information on the Aveir DR leadless cardiac pacemaker (LP) system in a population indicated for de novo dual-chamber pacing. Additionally, the PMS will collect data on rollover patients from the Aveir DR i2i IDE, Aveir AR LP in patients indicated for single-chamber… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leadless Pacemaker
- What is being tested?
- Aveir DR Leadless Pacemaker Implant, Single-chamber atrial Aveir patients and Upgrades
- Type of treatment
- Medical device
- How many people
- 304 participants
- Where
- 14 sitesJapan
- Study dates
- 26 May 2025to Nov 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The Surveillance will register patients who are indicated for dual-chamber leadless pacemaker, single-chamber atrial leadless pacemaker, roll-over patients with existing Aveir DR leadless pacemaker system from the Aveir DR i2i IDE study, and upgrade patients with existing single-chamber Aveir leadless pacemaker that require an upgrade to a dual-chamber Aveir leadless pacemaker system.
Who may be able to join
- Patient is indicated for dual-chamber or single-chamber atrial leadless pacemaker system
- Patient is a roll-over patient with existing Aveir DR leadless pacemaker system from the Aveir DR i2i IDE study
- Patient is an upgrade patient with existing single-chamber Aveir leadless pacemaker that requires an upgrade to a dual-chamber Aveir leadless pacemaker system
Who cannot join
- N/A
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Stephanie Delgado contact
14 sites in 1 country
Japan14 sites, 14 recruiting
- Recruiting
Chiba University Hospital
Chiba, 260-8677
Yusuke Kondo, 043-222-7171, trad-project@chiba-u.jp
- Recruiting
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191
Yoko Miyasaka, 072-804-0101, kmuccr@kmu.ac.jp
- Recruiting
Juntendo University Shizuoka Hospital
Izunokuni, Shizuok, 410-2295
Tomoyuki Shiozawa, t-shio@juntendo.ac.jp
- Recruiting
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagwa, 2168511
Ikutaro Nakajima, (044) 977-8111, ikutaro0817@marianna-u.ac.jp
- Recruiting
Kokura Memorial Hospital
Kitakyushu, Fukuoka, 802-8555
Kenji Ando, Dr, 81935112000, kenji.ando.rkc@gmail.com
- Recruiting
Kurashiki Central Hospital
Kurashiki, Okayama-ken, 710-0052
Hiroshi Tasaka, 81-86-422-0210, ht10970@kchnet.or.jp
- Recruiting
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8550
Yasuya Inden, 052-789-5111, inden@med.nagoya-u.ac.jp
- Recruiting
Osaka Keisatsu Hospital
Osaka, Osaka, 543-8922
Hitoshi Minamiguchi, hminamiguchi@gmail.com
- Recruiting
Toho University - Omori Medical Center
Ōta-ku, Tokyo, 143-8541
Masaya Shinohara, 03-3762-4151, masaya.shinohara@med.toho-u.ac.jp
- Recruiting
Sendai Kousei Hospital
Sendai, Miyagi, 981-0914
Kennosuke Yamashita, kennosuke.atmm3@gmail.com
- Recruiting
Showa Medical University Hospital
Shinagawa-ku, Tokyo, 142-8666
Taku Asano, 03-3784-8000, ctsc.admin@ofc.showa-u.ac.jp
- Recruiting
National Cerebral & Cardiovascular Center Hospital
Suita, Osaka, 564-8565
Kengo Kusano, MD
- Recruiting
Tokyo Medical University Hospital
Tokyo, 160-0023
Kazuhiro Satomi, 81333426111, ksatomi@tokyo-med.ac.jp
- Recruiting
Tokyo Women's Hospital
Tokyo, 162-8666
Daigo Yagishita, 03-3353-8111, yagishita.daigo@twmu.ac.jp
About this study
Official title: Aveir Leadless Pacemaker Japan Post Marketing Surveillance
The primary purpose of the PMS is to collect safety information on the Aveir DR leadless cardiac pacemaker (LP) system in a population indicated for de novo dual-chamber pacing. Additionally, the PMS will collect data on rollover patients from the Aveir DR i2i IDE, Aveir AR LP in patients indicated for single-chamber pacing in the right atrium, and upgradeability in patients implanted with single-chamber Aveir atrial or ventricular LP that require an upgrade to a dual-chamber Aveir LP.
- Conditions
- Leadless Pacemaker
- Being tested
- Aveir DR Leadless Pacemaker Implant, Single-chamber atrial Aveir patients, Upgrades, Roll-over
- Keywords
- leadless pacemaker, AVEIR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aveir DR Leadless Pacemaker ImplantDevice
Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium
Single-chamber atrial Aveir patientsDevice
Patients will undergo a single chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right atrium
UpgradesDevice
Patients with an existing single-chamber leadless pacemaker will undergo a leadless pacemaker system implant wherein an additional leadless pacemaker will be implanted in either the right ventricle or right atrium to form a dual-chamber LP system.
Roll-overDevice
Patients with an existing active Aveir DR leadless pacemaker system are eligible to be rolled into the Aveir Japan PMS upon consent for ongoing follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Primary Analysis Cohort | This survey targets the registration of 194 patients indicated for de novo dual-chamber LP's. All de novo patients will be followed until the last de novo dual-chamber patient (Aveir Japan PMS primary analysis cohort) reaches 3 years of follow-up Receives: Device: Aveir DR Leadless Pacemaker Implant | |
| Single-chamber atrial Aveir patients | Up to 50 patients indicated for a de novo atrial LP may be registered during the primary de novo dual-chamber LP registration period. Data will be analyzed separately, and the patients will be followed until the last de novo dual-chamber patient (primary analysis cohort) reaches 3 years of follow-up Receives: Device: Single-chamber atrial Aveir patients | |
| Upgrade Patients | Up to 36 upgrade patients (existing ventricular LP to dual-chamber LP system or existing atrial LP to dual-chamber LP system) may be registered during the primary de novo dual-chamber LP registration period. Data will be analyzed separately, and the patients will be followed until the last de novo dual-chamber patient (primary analysis cohort) reaches 3 years of follow-up Receives: Device: Upgrades | |
| Rollover | All patients from Japan sites with existing active Aveir LPs from the Aveir DR IDE i2i Study (up to 24 patients) are eligible to roll over into the Aveir Japan PMS upon consent for ongoing follow-up. Data from the rollover patients will be summarized separately. Rollover patients will be followed until the last de novo dual-chamber patient (Aveir Japan PMS primary analysis cohort) reaches 3 years of follow-up Receives: Device: Roll-over |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
The primary safety endpoint of this PMS evaluates the 3-year Aveir DR LP system complication-free rate in de novo Aveir DR patients (primary analysis group).
A complication is defined as a device-or-procedure-related serious adverse device effect (SADE), including those that prevent initial implantation (includes both Atrial LP and Ventricular LP related complications and implant procedure-related complications).
Measured: 36-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start26 May 2025
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leadless PacemakerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 304 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106788
- Sponsor's protocol ID
- CL1027565
- Status last verified
- May 2026
- First submitted
- 30 Jul 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Any de-identified individual participant data collected will be shared with investigators whose proposed use of the data has been approved by Abbott
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aveir Leadless Pacemaker Japan Post Marketing Surveillance
- ClinicalTrials.gov ID
- NCT07106788
- Acronym / sponsor ID
- CL1027565
- Conditions
- Leadless Pacemaker
- Keywords
- leadless pacemaker, AVEIR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 26 May 2025 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the PMS is to collect safety information on the Aveir DR leadless cardiac pacemaker (LP) system in a population indicated for de novo dual-chamber pacing. Additionally, the PMS will collect data on rollover patients from the Aveir DR i2i IDE, Aveir AR LP in patients indicated for single-chamber pacing in the right atrium, and upgradeability in patients implanted with single-chamber Aveir atrial or ventricular LP that require an upgrade to a dual-chamber Aveir LP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Primary Analysis Cohort | – | Device: Aveir DR Leadless Pacemaker ImplantThis survey targets the registration of 194 patients indicated for de novo dual-chamber LP's. All de novo patients will be followed until the last de novo dual-chamber patient (Aveir Japan PMS primary analysis cohort) reaches 3 years of follow-up |
| Single-chamber atrial Aveir patients | – | Device: Single-chamber atrial Aveir patientsUp to 50 patients indicated for a de novo atrial LP may be registered during the primary de novo dual-chamber LP registration period. Data will be analyzed separately, and the patients will be followed until the last de novo dual-chamber patient (primary analysis cohort) reaches 3 years of follow-up |
| Upgrade Patients | – | Device: UpgradesUp to 36 upgrade patients (existing ventricular LP to dual-chamber LP system or existing atrial LP to dual-chamber LP system) may be registered during the primary de novo dual-chamber LP registration period. Data will be analyzed separately, and the patients will be followed until the last de novo dual-chamber patient (primary analysis cohort) reaches 3 years of follow-up |
| Rollover | – | Device: Roll-overAll patients from Japan sites with existing active Aveir LPs from the Aveir DR IDE i2i Study (up to 24 patients) are eligible to roll over into the Aveir Japan PMS upon consent for ongoing follow-up. Data from the rollover patients will be summarized separately. Rollover patients will be followed until the last de novo dual-chamber patient (Aveir Japan PMS primary analysis cohort) reaches 3 years of follow-up |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The Surveillance will register patients who are indicated for dual-chamber leadless pacemaker, single-chamber atrial leadless pacemaker, roll-over patients with existing Aveir DR leadless pacemaker system from the Aveir DR i2i IDE study, and upgrade patients with existing single-chamber Aveir leadless pacemaker that require an upgrade to a dual-chamber Aveir leadless pacemaker system.
Key inclusion criteria (3 listed)
- Patient is indicated for dual-chamber or single-chamber atrial leadless pacemaker system
- Patient is a roll-over patient with existing Aveir DR leadless pacemaker system from the Aveir DR i2i IDE study
- Patient is an upgrade patient with existing single-chamber Aveir leadless pacemaker that requires an upgrade to a dual-chamber Aveir leadless pacemaker system
Key exclusion criteria (1 listed)
- N/A
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 ImplantPatients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium | Device | Primary Analysis Cohort |
| Single-chamber atrial Aveir patientsPatients will undergo a single chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right atrium | Device | Single-chamber atrial Aveir patients |
| UpgradesPatients with an existing single-chamber leadless pacemaker will undergo a leadless pacemaker system implant wherein an additional leadless pacemaker will be implanted in either the right ventricle or right atrium to form a dual-chamber LP system. | Device | Upgrade Patients |
| Roll-overPatients with an existing active Aveir DR leadless pacemaker system are eligible to be rolled into the Aveir Japan PMS upon consent for ongoing follow-up. | Device | Rollover |
Primary outcome
Primary Safety Endpoint
Time frame: 36-month
The primary safety endpoint of this PMS evaluates the 3-year Aveir DR LP system complication-free rate in de novo Aveir DR patients (primary analysis group). A complication is defined as a device-or-procedure-related serious adverse device effect (SADE), including those that prevent initial implantation (includes both Atrial LP and Ventricular LP related complications and implant procedure-related complications).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Yes. Any de-identified individual participant data collected will be shared with investigators whose proposed use of the data has been approved by Abbott
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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.
Stephanie Delgado contact
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leadless Pacemaker, run by Abbott Medical Devices at 14 sites in Japan.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 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 14 sites in Japan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mieko Otake (+81-80-5866-9006, mieko.otake@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 36-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2026.